2015 quality management system vendor benchmark

INTRODUCTIONThe purpose of this survey was to collect data from companies on enabling technology currently used to support

key areas of their Quality Management System.

Data was collected from the LinkedIn Quality & Regulatory Network group representing over 100,000

professionals worldwide. Over 716 members from multiple industries participated.

Percentages do not reflect data for market share, only selections from survey participants.

Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix. Not all

vendors may be represented in their category. If you are a Vendor that is not currently on our list, we welcome the

chance to have you participate in the 2016 QMS Vendors Benchmark Survey.

Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality & Regulatory

Network.

The Quality & Regulatory Network would like to thank Hiren Patel and Jacqueline Birkel for their help in creating

this report. I would also like to give special recognition and thanks to C.M. Schramm for her on-going support and

her help in getting this report finished.

2Q U A L I T Y & R E G U L A T O R Y N E T W O R KC o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k

*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

LinkedIn, the LinkedIn logo, the IN logo and InMail are registered trademarks or trademarks of

LinkedIn Corporation and its affiliates in the United States and/or other countries. All other references

to company and product names are copyright in their own right.

Copyright 2015. Quality & Regulatory Network by Nikki Willett. All rights reserved.

https://www.surveymonkey.com/r/QMS_vendors_2016

mailto:[email protected]?subject=QMS Software Vendor Survey

http://www.linkedin.com/groups?home=&gid=80327&trk=anet_ug_hm

OBSERVATIONS

Q U A L I T Y & R E G U L A T O R Y N E T W O R KC o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 3

The top 5 vendors selected

overall cover 37% of the total

vendor footprint

MasterControl

Trackwise (Sparta Systems)

SAP

ACE (PSC Software)

SharePoint

Manual processes still

predominant over automation

Of the companies leveraging 100%

SaaS solutions, 50% were small

companies ($1-25M revenue)

On average, companies’ oldest

systems (>10 years) are their

Calibration, EH&S, MES, PLM, SPC

and Supplier Quality systems

(43%)

Most companies’ systems are

between 1-3 years old (57%).

Increase of participants from

discrete industries such as Medical

Device

Custom developed systems

reducing probably to adoption

of available Out-of-the-Box

applications


Demographics

SaaS / Cloud Systems Used

Internal/External Audit

Calibration & Maintenance

CAPA (Corrective & Preventive Actions)

Change Control

Complaints

Document Management

Exceptions (Deviations, Nonconformances)

Environmental Health & Safety (EH&S)

Laboratory Management (LIMS, ELN)

Manufacturing Execution System (MES)

Product Lifecycle Management (PLM)

Statistical Process Control (SPC/PAT)

Supplier Quality

Training

Selected Comments from Participants

Appendix I – Selected Vendor Profiles

Appendix II – Vendor List

DEMOGRAPHICSREPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY


Note: Some answers were consolidated under one industry while those with only a single response were allocated to "Other."


2015COMPARISON

TO 2014

TOC

DEMOGRAPHICS 2015REPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE


Annual Revenue

2015


Annual Revenue

Comparison to 2014

33.1%

27.9%

12.2%

26.8%

less than 25M 26-500M

500-999M more than 1B

TOC

DEMOGRAPHICS – COMPARISON 2014REPRESENTATION FROM PARTICIPANTS ABOUT THEIR ROLE OR FUNCTION WITHIN

THE COMPANY


Role / Function

2015

Role / Function

Comparison to 2014


8.2% 5.7%

8.7%

3.1%

50.7%

7.5%

2.7% 13.4%

Compliance

C-Suite/Executive Office

IT

Manufacturing

Quality

Regulatory

R&D

Other

TOC

DEMOGRAPHICS 2015REPRESENTATION FROM PARTICIPANTS ABOUT THEIR GEOGRAPHICAL REGION


Geographical Regions

2015

*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015TOC

PERCENT OF SAAS / CLOUD-BASED SYSTEMS USED

FOR QUALITY MANAGEMENT SOLUTIONS



14.0%

7.8%

5.1%7.4%

7.6%

8.5%

Less than 10%

Between 11-25%

Between 26-50%

Between 51-75%

Between 76-99%

100% are SaaS/Cloudbased

100% SaaS/Cloud!Growing Trend

TOC


Please note that each Category has three parts:

• 2015 Response

• Time & Satisfaction with the System

• Vendor list of those with less than 1% response

For those Categories that were in the 2014 QMS

Benchmark, we have provided an additional page

to show the 2015 vs. 2014 comparison.

11

Note: Some participants may have selected multiple systems if represented within their organizations.

Those software vendors with less than a 1% response are not reflected in the chart but are included in the

list of other Vendors.


Q U A L I T Y & R E G U L A T O R Y N E T W O R KC o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k

INTERNAL/EXTERNAL AUDIT

TOC

TIME & SATISFACTION WITH AUDIT SYSTEM


Rating for from 1-Awful to 5-Excellent

Average Rating for System: 3.75 Predominant System Usage: 1-3 years


TOC

COMPARISON TO 2014 SURVEY


TOC


OTHER VENDORS FOR AUDIT*


ActiveQ (Open Mind Solutions)

AssurX

Audit Weaver

BLUe-CAT Synergy

CAQ AG

Cebos

Centurion Quality Management

CIQA

CIS Software

CloudQMS (Cambio Services LLC)

Compliance 360 (SAI Global)

Compliance Control

ComplianceQuest

Enovia PLM (Dassault Systemes)

Entropy (BSI)

FlinkISO open source (Techmentis)

Formpipe.GxP (Formpipe Software AB)

GMPPro (MOTTO Systems)

Greenlight.Guru

GSQA (EMNS Inc.)

Harrington Group International

IBS US

Ideagen PLC

IHS

Infotehna

Intelex

Interax Group

Integrum Management Systems

IQRC, Inc.

IQS, Inc.

Isoma (E Squared UK)

isoTracker (Lenox Hill Ltd.)

isoXpress (AQA Company)

MetricStream

Microsoft Navision

Montium

Muddy Boots Software

New Generation Computing,

Inc. (NGC)

NextDocs

Novatek International

Omnex

Optiva PLM (Infor)

Oracle

Pastel Auditor (Sage)

Pilgrim Quality Solutions

Q5 Systems

QAD

QAI (Quality Institute of

America)

QMSrs Ltd

QPR Software PLC

QT9 (World Quality Systems)

Quality Link Software

Quality Systems Toolbox

Qualtrax

Quarta (Blulink)

Qumas (Dassault Systemes)

Rescop

Rivo Safeguard

Salesforce

New Generation Computing,

Inc. (NGC)

NextDocs


Omnex

Optiva PLM (Infor)

Oracle

Pastel Auditor (Sage)

Sercle QMS

ServiceNOW

SimpleTrak (ION Quality

Systems)

SoftExpert Software

Solabs

Sword Achiever

The Lean Machine

Tip Technologies

Title21 Health Solutions

uniPoint Software

Verse Solutions

Vintara

Windchill Quality Suite (PTC)

*Vendors having less than 1% responseTOC


15






CALIBRATION AND MAINTENANCE

TOC

TIME & SATISFACTION WITH CALIBRATION AND

MAINTENANCE SYSTEM



Average Rating for System: 3.38 Predominant System Usage: > 10 years

TOC


OTHER VENDORS FOR CALIBRATION AND

MAINTENANCE*




4Sight (GE)

A2Z Manager (Reetec)

Access Automation


Ambrit

Ape Software

Aras Corp

AssetSmart

Bright Interactive

Caliber Series (Dhruthi Technologies)

Caliso

Calspex (Vantek Software)

CalTrak (Transcat)

CAMA Software LLC

Cebos

CERDAC (Simco Electronics)

ChartHouse Data Management

CIQA

CIS Software

CMX (Beamex)

CompuCal Calibration Solutions

CPRO 2000 Plus (BDR Systems)

DataLyzer

EasyCal (Time Electronics)

ETQ

Fast Track (Aust) Pty LTD.

GageControl (Quality Software

Concepts)

Gage Insite (Indysoft

Corporation)

GageList (Expresso Moon)

GageManager (Altegra)

GAGEpack (PQ Systems)

Grand Avenue Software

Greenlight.Guru


iBASEt

IBS US

IN-CAL

Infor

Interax Group


IQMS

IQRC, Inc.

IQS, Inc.

MAPEX Software

Neomatics


Omnex

ProCAL (Prime Technologies)

QAD

QAI (Quality Institute of America)

QMSrs Ltd

Qualisyst Ltd.



Rescop

Sercle QMS

SimpleTrak (ION Quality

Systems)

Sirwill FBM (Global Quality

Village)

SISTRADE Solutions

SoftExpert Software

SoftTech Health LLC

Solabs

Tech-X (Cetex)


TrackPro

uniPoint Software

Vintara

Visual Enterprise Solutions

V-Soft computers

Wonderware (Invensys /

Schneider Electric)

xTrak (usCalibration)

CAPA (CORRECTIVE & PREVENTATIVE ACTION)

18






0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

Ma

nu

al

Cu

sto

m D

eve

lop

ed

AC

E (

PS

CS

oft

wa

re)

Ag

ile P

LM

(O

racle

)

ET

Q

GM

PP

ro (

MO

TT

OS

yste

ms)

iCO

LO

GIQ

(fo

rme

rly

Qu

alit

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nlin

e)

Ma

ste

rCo

ntr

ol

QA

Syste

ms

(QA

SY

S)

Q-P

uls

e (

Ga

el)

SA

P

Sh

are

Po

int

(Mic

roso

ft)

Tra

ckw

ise

(S

pa

rta

Syste

ms) O

the

r

What system or systems do you use for CAPA within your company?

TOC

TIME & SATISFACTION WITH CAPA SYSTEM




TOC




TOC


OTHER VENDORS FOR CAPA*




123Compliance


Adaptive BMS

AssurX

BLUe-CAT Synergy

Bugzilla

CAMA Software LLC

Cebos

CIQA

CIS Software


Compliance Control

Compliance Quest

Empower PLM (Omnify Software)

Ensur (Docxellent)

Entropy (BSI)





Greenlight.Guru


HP Quality Center

iBASEt

IBS US

Ideagen PLC

Infotehna

Intelex

Interax Group


IQMS

IQRC, Inc

IQS, Inc.


JIRA (Atlassian)

Job BOSS (Exact Business Software)

MetricStream

Montium

Neomatics

NetRegulus (PTC)

NextDocs


Omnex


ProMation Systems Inc. (PSI)

Q5 Systems


QMSrs Ltd

QPR Software PLC

QUAD (Aster Technologies)



Qualtrax

Quarta (Blulink)


Redmine

Rescop

ReSol Technologies

Rivo Safeguard

Sercle QMS

ServiceNOW

SimpleTrak (ION Quality Systems)

SoftExpert Software

SoftTech Health LLC

Solabs

Sword Achiever

TeamPage (Traction Software)

Tech-X (Cetex)

Tip Technologies


TQS-9000 (ISP Software Solutions)

uniPoint Software

Verse Solutions

Vintara

Vivaldi Software


ZenQMS (formerly The QAB)

CHANGE CONTROL

22






0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

Ma

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12

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om

plia

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AC

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(O

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Gra

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iCO

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(fo

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On

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)

Info

teh

na

Ma

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SA

P

Sh

are

Po

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(Mic

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Tra

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(S

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Ze

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MS

(fo

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he

QA

B)

Oth

er

TOC

TIME & SATISFACTION WITH CHANGE CONTROL

SYSTEM




TOC




TOC


OTHER VENDORS FOR CHANGE CONTROL*




123Compliance

Aras Corp

Arena Solutions

AssurX

Autodesk PLM

BLUe-CAT Synergy

Bugzilla

CAMA Software LLC

CAQ AG

CIQA


eMatrix/Matrix One PLM (Dassault Systemes)



Ensur (Docxellent)

Entropy (BSI)


Greenlight.Guru

IBS US

iCOLOGIQ (formerly Quality Online)

Ideagen PLC

IHS

Infotehna

Intelex

IQMS

IQS, Inc.

ISTM (Remedy)

JD Edwards

JIRA (Atlassian)

Kintana (HP/Mercury Interactive)

MetricStream

Montium

NextDocs


Optiva PLM (Infor)

PDXpert PLM (Active Sensing)


Q5 Systems

QAD

QA Systems (QASYS)


Qualtrax


Rational (IBM)

Rescop

ReSol Technologies

Selerant

Siemens PLM

Solabs

Sopheon

Sword Achiever

Tip Technologies


Trace One

Veeva

ZenQMS (formerly The QAB)

COMPLAINTS






0.0%

5.0%

10.0%

15.0%

20.0%

25.0%M

an

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12

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(fo

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On

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)

IQM

S

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Pilg

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Qu

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tio

ns

Sa

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SA

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(Mic

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Tra

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(S

pa

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Win

dch

ill Q

ua

lity S

uite

(PT

C)

Oth

er

TOC

TIME & SATISFACTION WITH COMPLAINTS

SYSTEM




TOC




TOC


-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Ma

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12

3C

om

plia

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AC

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PS

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oft

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Arg

us (

Ora

cle

)

ETQ

Fa

st

Tra

ck

(A

ust

) P

ty L

TD

.

GM

PP

ro (

MO

TTO

Sys

tem

s)

iCO

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(fo

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Qu

ality

On

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e)

IQM

S

Ma

ste

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Pilgri

m Q

ua

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So

luti

on

s

Sa

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SA

P

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Tra

ck

wis

e (

Sp

art

a S

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Win

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ill Q

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Su

ite

(P

TC

)

Oth

er

OTHER VENDORS FOR COMPLAINTS*




Aris Global

AssurX

BLUe-CAT Synergy

Breeze Software

Bugzilla

CAMA Software LLC

CAP Software

CAQ AG

CIS Software


Complaints Pro (Coretec Solutions)

Compliance Control

Compliance Quest

Documentum (EMC)

DRM (Donor Dialog)

Entropy (BSI)

ePowerCenter (Astute Solutions)

Ethics Point (NAVEX Global)

eTracker

Everest (Lynk Software)


Greenlight.Guru

IBS US

Ideagen PLC

Infotehna

Intelex

Interax Group

IQRC, Inc

IQS, Inc.

i-Sight (Customer Expressions)


IssueTrak

JIRA (Atlassian)

M3 (Rover Data Systems, LLC)

MetricStream

mHelpDesk

Microsoft Dynamics

Montium

NetRegulus (PTC)


Onyx (Aptean)

Optiva PLM (Infor)

Pinnacle Business Solutions

PIVOTAL (Aptean)

QT9 (World Quality Systems)


Quarta (Blulink)


Sage PLM

Samanage

Sercle QMS

ServiceNOW

Siebel (Oracle)


SISTRADE Solutions

Tip Technologies


uniPoint Software

Veeva

Velocity Software

Verse Solutions

Vintara

Vivaldi Software

DOCUMENT MANAGEMENT






0.0%2.0%4.0%6.0%8.0%

10.0%12.0%14.0%16.0%18.0%20.0%

Ma

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12

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Ag

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(O

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Do

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Info

teh

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Q-P

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Ga

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Qu

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Da

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P

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(Mic

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Ve

eva

Win

dch

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uite

(PT

C)

Ze

nQ

MS

(fo

rme

rly T

he

QA

B)

Oth

er

TOC

TIME & SATISFACTION WITH DOCUMENT

MANAGEMENT SYSTEM




TOC




TOC


-20.0%

-10.0%

0.0%

10.0%

20.0%

30.0%

40.0%

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Ma

nu

al

Cu

sto

m D

eve

lop

ed

AC

E (

PS

C S

oft

wa

re)

Agile

PLM

(O

racle

)

Do

cum

en

tum

(E

MC

)

ETQ

Fa

st

Tra

ck

(A

ust

) P

ty L

TD

.

GM

PP

ro (

MO

TTO

Sys

tem

s)

Gra

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Ave

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wa

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(fo

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Qu

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On

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Ma

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Q-P

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Ga

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Qu

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s (

Da

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Sys

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SA

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(Mic

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Ve

eva

Oth

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OTHER VENDORS FOR DOCUMENT

MANAGEMENT*





Arena Solutions

AssurX

BLUe-CAT Synergy

Blue Mountain

CAMA Software LLC

Camstar (Siemens)

Cebos

CIQA



Compliance Control

ComplianceQuest

Documentum (EMC)

eDOCS (OpenText)

Matrix One PLM (Dassault Systemes)



Ensur (Docxellent)

Entropy (BSI)

Epicor

Epiware




Greenlight.Guru


iBASEt

IHS

Infotehna

Intelex

Interax Group


IQMS

IQRC, Inc

IQS, Inc.


Lotus Notes

MetricStream

Montium

Neomatics

NextDocs


Omnex

Oracle


Q5 Systems


QA Systems (QASYS)

QMSrs Ltd



Quality-Works (KvalitetsGruppen)

Qualtrax

Quarta (Blulink)


Redmine

Rescop

ReSol Technologies

Rivo Safeguard

Rockwell

ServiceNOW

SIMATIC (Siemens)


SoftExpert Software

Solabs

Sword Achiever


Tech-X (Cetex)

Tip Technologies


uniPoint Software

Verse Solutions

Vintara


Vivaldi Software


Windchill PLM (PTC)

EXCEPTIONS(DEVIATIONS, EVENTS, NONCONFORMANCES, OUT OF SPEC/TOLERANCE/TREND)






0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

Ma

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12

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A (

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TOC

TIME & SATISFACTION WITH EXCEPTIONS

DEVIATIONS/NON-CONFORMANCES) SYSTEM




TOC




TOC


OTHER VENDORS FOR EXCEPTIONS

DEVIATIONS/NON-CONFORMANCES) *





Arena Solutions

AssurX

BLUe-CAT Synergy

Blue Mountain

CAMA Software LLC

Camstar (Siemens)

Cebos

CIQA



Compliance Control

ComplianceQuest

Documentum (EMC)

eDOCS (OpenText)




Ensur (Docxellent)

Entropy (BSI)

Epicor

Epiware




Greenlight.Guru


iBASEt

IHS

Infotehna

Intelex

Interax Group


IQMS

IQRC, Inc

IQS, Inc.


Lotus Notes

MetricStream

Montium

Neomatics

NextDocs


Omnex

Oracle


Q5 Systems


QA Systems (QASYS)

QMSrs Ltd



Quality-Works (KvalitetsGruppen)

Qualtrax

Quarta (Blulink)


Redmine

Rescop

ReSol Technologies

Rivo Safeguard

Rockwell

ServiceNOW

SIMATIC (Siemens)


SoftExpert Software

Solabs

Sword Achiever


Tech-X (Cetex)

Tip Technologies


uniPoint Software

Verse Solutions

Vintara


Vivaldi Software


Windchill PLM (PTC)

EH&S COMPLIANCE MANAGEMENT






0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

Ma

nu

al

Cu

sto

m D

eve

lop

ed

AC

E (

PS

C S

oft

wa

re)

MS

DS

on

line

SA

P

ZL

C S

oft

wa

re

Oth

er

TOC

TIME & SATISFACTION WITH EH&S

COMPLIANCE MANAGEMENT SYSTEM




TOC


OTHER VENDORS FOR EH&S COMPLIANCE

MANAGEMENT *




Affytrac (Affygility Solutions)

Arena Solutions

Aris Global

ASKEHS Engineering

AssessNet

Assure (SHE Software)

BLUe-CAT Synergy

Cintellate (SAI Global)

CIQA

CloudSDS

CMO Software

COMPASS (Process Data Control)

Compli

Cyanic Automation

DataPipe (Knorr Associates)

DoneSafe

e3 Solutions

Ecocion

EcoIntense

ecoLOGIC Systems

eCompliance Management

Solutions

EHASoft

EHelioS

EHS Data Limited

EHS Insight (StarTex Software)

EMEX

EMSolution (Solution Foundry)

Enablon

Entropy (BSI)

Enviance

ERA Environmental Management

Solutions

ETQ


Field iD (Master Lock)

FlexMMS (CGA Software)

Hamsagars

HAZMIN (Logical Technology)


ImageWave

IndustrySafe (TRA, Inc.)

Intelex

KMI

Knowledge Global

Medgate

MIRS (A V Systems)

Neosystems

Open Mind Solutions

Proactive Health and Safety

Solutions

ProntoForms

Prospecta Software

QPR Software PLC

Remedy Interactive

Rivo Safeguard

Saeker Systems

Safety Concepts Group

Safety Tracker Software

SafetyReports.com

SafetySync

SFS Chemical Safety

Simply Safety (CCD Systems)

Smaat (Maerix)

SOAR Solutions

SoftExpert Software

Spiramid

uniPoint Software

webOSCAR (Verdi Technology

Assoc.)

ZeraWare

LABORATORY MANAGEMENT




Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those software

vendors with less than a 1% response are not reflected in the chart but are included in the list of other

Vendors.

TOC

TIME & SATISFACTION WITH LABORATORY

MANAGEMENT SYSTEM



Average Rating for System: 3.25 Predominant System Usage: 1-3 years but

close to over 10 years

TOC




TOC


OTHER VENDORS FOR LABORATORY

MANAGEMENT *




ABB LIMS

Accelerys (Dassault Systemes)

Apollo LIMS (Common Cents Systems)

Blaze LIMS (Blaze Systems)

BLISS LIMS (Baytek International)

Clinsys Group

CORE LIMS (Core Informatics)

CSC LIMS

Csols Ltd

Eusoft Srl

IDBS ELN

Labsoft (Computing Solutions)

LIMS / LABWORKS (PerkinElmer)

LabVantage (SQL*LIMS)

mHelpDesk


Oracle Harvest

Rescop

UniLab (Siemens)

Wavefront Software

Zumatrix (Autoscribe Informatics)

MANUFACTURING EXECUTION SYSTEM /

MANUFACTURING OPERATIONS MANAGEMENT






Vendors.

TOC

TIME & SATISFACTION WITH MES/MOM SYSTEM




TOC


OTHER VENDORS FOR MES/MOM *




Aegis

Apriso (Dassault Systemes)

AspenTech

CIMx Software

Cincom

Critical Manufacturing

Epicor

Eyelit, Inc

Factory (Aptean)

Fusion Systems

HighJump Software

Honeywell Process Solutions

iBASEt

IBS US

iTac Software

JDA

Lighthouse Systems Limited

MAPEX Software

MPDV USA

NetSuite

Performix, Inc

Plex Systems

Prodac Systems

QAD

SIMATIC (Siemens)

SISTRADE Solutions

TrakSYS (Parsec Automation)

PRODUCT LIFECYCLE MANAGEMENT (PLM)






Vendors.

TOC

TIME & SATISFACTION WITH PLM SYSTEM




TOC


OTHER VENDORS FOR PLM*




Aras Corp

Arena Solutions

Autodesk PLM

Dexma

eMatrix/Matrix One PLM (Dassault Systemes)



Greenlight.Guru

IFS

Infor

IQMS

Kalypso

New Generation Computing, Inc. (NGC)

OnePlace (Eclipse Computing Australia Pty Ltd)

PDXpert PLM (Active Sensing)

Selerant

SLIM (InterCAX)

SofTech Inc.

Sopheon

Trace One

STATISTICAL PROCESS CONTROL (SPC) / PROCESS

ANALYTICAL TECHNOLOGY (PAT)






Vendors.

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

Ma

nu

al

Cu

sto

m D

eve

lop

ed

Ce

bo

s

Infin

ity Q

S

IQM

S

Mic

roso

ft E

xce

l

Min

ita

b

No

rth

we

st

An

aly

tics

(NW

A)

Oth

er

TOC

TIME & SATISFACTION WITH SPC/PAT SYSTEM




TOC


OTHER VENDORS FOR SPC/PAT*




Aegis

ASI DataMyte

CAMO Software AS

Cebos

DataLyzer

Dimensional Control Systems

Intrastage

IQS, Inc.

ISP Software Solutions

PlantNet (Altegra)

PQ Systems

QTi

Qualitron Systems

SIMATIC (Siemens)

Sirwill FBM (Global Quality Village)

SoftExpert Software

Symbion Systems, Inc.

Synergy (Zontec)

WinSPC (DataNet Quality Systems)

SUPPLIER QUALITY






TOC

TIME & SATISFACTION WITH SUPPLIER QUALITY

SYSTEM




TOC




TOC


OTHER VENDORS FOR SUPPLIER QUALITY*




Adaptive BMS

Aras Corp

Arena Solutions

Ariba

AssurX

Audit Weaver

BLUe-CAT Synergy

CAMA Software LLC

CAQ AG

CIQA

Civerex Systems Inc.



Compliance Control

ComplianceQuest

GAGEtrak/SUPPLIERtrak (CyberMetrics

Corporation)

Documentum (EMC)


Entropy (BSI)

Epicor

EPIQ Technologies, Inc.



GSQA (EMNS Inc.)

iBASEt

IBS US

Infor

Infotehna

Intelex

Interax Group

IQMS

IQRC, Inc

IQS, Inc.

JDA

Job BOSS (Exact Business Software)

M3 (Rover Data Systems, LLC)

MetricStream

Microsoft Navision

Muddy Boots Software

Net-Inspect

New Generation Computing, Inc. (NGC)

Pharmschul (GMP Software)


Pinnacle Business Solutions

Plex Systems

ProcessPro

QAD


QA Systems (QASYS)



Qualtrax

Qube Software


Rivo Safeguard

Sercle QMS


Sword Achiever

Tip Technologies



uniPoint Software

Vintara


TRAINING/LEARNING MANAGEMENT






TOC

TIME & SATISFACTION WITH TRAINING SYSTEM




TOC




TOC


OTHER VENDORS FOR TRAINING/LEARNING

MANAGEMENT*




123Compliance


AssurX

CAMA Software LLC

CAP Software

CAQ AG

Cebos

CIQA

Claromentis


Compliance Control

ComplianceQuest

Cornerstone OnDemand

Dokeos

ecoLOGIC Systems



Ensur (Docxellent)

Entropy (BSI)

eTraininfo (CIMCON Software)




GMPPro (MOTTO Systems)

Greenlight.Guru

Halogen Software


HealthStream

IBS US


iLearning (Seertech)

Infotehna

Intelex

Interax Group


IQRC, Inc

IQS, Inc.

Learn.com (Oracle)

LearningPlus

MetricStream

Montium

Neomatics

NextDocs


Noverant

Pharmschul (GMP Software)



QMSrs Ltd



Qualtrax


Rescop

ReSol Technologies

Seertech

Sercle QMS


SoftExpert Software

SumTotal

Sword Achiever

Taleo (Oracle)

TEDS Inc.

Tip Technologies


TMS (Collaborative Quality Systems)


uniPoint Software

uPerform (ANCILE)

Verse Solutions

Vintara

Vivaldi Software

ZenDoc (GetZenDoc)

SELECTED COMMENTS BY PARTICIPANTS


• We want regulatory agencies to encourage the use of enabling technology for QMS• From our research, these tools are too expensive for a small company• In our experience, MasterControl works well in our Manufacturing and Quality Processes and contributed to our Audit success• We are a PET radiopharmaceutical manufacturer and find that many of the "out-of-the-box" systems are too broad for our

needs.

• There need to be more systems available on a trial basis• Systems need to have tutorial/demo videos for the main users and stakeholders• We’re seeing a trend towards purely SaaS solutions where the TCO is very competitive. This simplifies the way software is managed

from a client perspective• Aadvark is a newer system that we’re leveraging and is set to impact Supply Chain Quality Management• A simpler User Interface is something we need and want to start seeing among these technologies• Technologies can be poorly mapped to process because vendors cannot always know what the requirements are• We have a concern regarding continuous connectivity and speed of processing data• Our company typically invests more in new product and customer acquisition than they do in QA• We’re changing our PLM system and are interested in what other companies are doing• We try to automate a lean process and customize too often in doing so. There need to be more industry-accurate out-of-the-box

functionalities• Integrated Software that can be added onto existing ERPs could cater to Quality and Supplier Document Management• We need to increase SaaS conceptual education within our company so that our average employee understands what SaaS is

TOC


SELECTED COMMENTS BY PARTICIPANTS


• Our group has identified a BI (Business Intelligence) solution sitting on top of core ERP and databases as making the most sense• My company invests more money in new product and customer acquisition than they do in Quality Assurance.

• We are currently changing to a PLM system and is interested in knowing what people think i.e. the result of the survey

• Integration in existing IT landscape and what is really the single source of truth for quality data

• I want all quality related practices should come under one software

• We often do not define a lean process before we try to automate it. We often try to customize too much instead of utilizing out

of the box

• Global corporate-wide solutions have become the standard. Unfortunately many - even market-leading - SW vendors do often

not offer according technologies / functionality.

• Another typical deficiency are insufficient QMS at the SW vendor, and vendor documentation often does not well support the

validation of the system.

• Responsibility for data entry, and time management negotiations for such activities are sticking points

• Currently our company has LIMS installed and we are in the process of implementing ELN. The reporting aspect of the LIMS

system is severely lacking. The system provides no standard reports; however you can create and validate your own reports

using Crystal Reports. This can become very costly if you do not have the skills in house.

• Lack of harmonization.

• Enterprise Integration Capabilities and if systems are used as true EQMS-platform for all quality related processes. Best of

Breed vs.Enterprise Platforms

TOC



Interested in having a Vendor Profile in next

year’s Survey? Fill out the 2016 Vendor

Profile Survey (now Open) or watch for next

request in the LinkedIn Quality & Regulatory

Network group in February 2016.

https://www.surveymonkey.com/r/QMS_vendors_2016

123Compliance Corporation

Website: www.123compliance.com

Contact: Rosalind BeasleyEmail: [email protected] Phone : +1 805 626 8666

HQ: 1525 State Street, Santa Barbara CA 93101 USA

Facts: Number of employees: 1-50Years in Business, Since: 2012Annual Revenue: Privately HeldGeographic Regions: Europe, North AmericaPrimary Industries: Biotechnology, Food & Beverages, Medical Device, Pharmaceuticals

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Exception Management (deviations, non-conformances, OOS, OOT, events), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Training Management

FDA 21 Part 11 Compliant: Yes License Type: SaaS (multi-tenant)

123Compliance is the first regulatory compliance solution built on Salesforce.com, the leading enterprise cloud platform. Designed specifically for the rigorous compliance needs of the life science industry, we offer out-of-the-box functionality to meet FDA requirements for the pharmaceutical, food, and medical device industries. Empowering companies to connect with customers in entirely new ways, 123Compliance taps into the power of social and mobile cloud technologies to transform the way our customers sell, service, market, and innovate.

L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 66

SELECTED VENDOR PROFILES*

* Vendors submitted profiles in support of the Survey

Arena Solutions

Website: www.arenasolutions.com

Contact: Umesh MalhotraEmail: [email protected] : +6505133587

HQ: United States

Facts: Number of employees: 51-200Years in Business, Since: 2000Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Biotechnology, Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Electrical & Electronic Manufacturing, Industrial Automation, Machinery, Medical Device, Oil, Gas, Renewables & Energy, Pharmaceuticals, Plastics, Railroad Manufacturing, Semiconductors, Telecommunications, Transportation/Trucking/Railroad

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Electronic Laboratory Notebook (ELN), Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Laboratory Information Management (LIMS, LIS, LES), Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release, Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Sample Management, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: SaaS (single tenant)

3 of the Top 5 Medical Device companies use Arena PLM.

http://www.123compliance.com/

http://www.arenasolutions.com/




AssetSmart

Website: www.assetsmart.com

Contact: Christopher J. Campbell

Email: [email protected]

Phone : +310-450-2566

HQ: 2800 28th Street Suite 109, Santa Monica, CA 90405

Facts: Number of employees: 1-50

Years in Business, Since: 1971

Annual Revenue: Privately Held

Geographic Regions: North America

Primary Industries: Defense & Space/Military, Logistics & Supply

Chain, Oil, Gas, Renewables & Energy

Solutions Offered: Equipment Calibration & Maintenance Management,

Test Asset Management

FDA 21 Part 11 Compliant: Yes

License Type: On-Premise

Founded in 1971, PMSC dba AssetSmart continues to provide industry

leading global asset management and calibration maintenance

management solutions for the Global 2000, space, defense,

communications, electronics and manufacturing companies as well as

major government facilities.

AssurX, Inc.

Website: http://www.assurx.com

Contact: Tamar JuneEmail: [email protected] : +408-778-1376, ext. 705

HQ: 18525 Sutter Blvd. Suite 150, Morgan Hill, CA 95037

Facts: Number of employees: 51-200Years in Business, Since: 1993Annual Revenue: Privately HeldGeographic Regions: Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Financial Services, Food & Beverages, Hospital & Health Care, Industrial Automation, Information Technology & Services, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Pharmaceuticals, Plastics, Semiconductors, Telecommunications, Tobacco, Utilities

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Product (Batch/Lot) Quality Release, Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, eMDR (Electronic Medical Device Reporting), UDI (Unique Device Identifier) system reporting

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant)

AssurX’s powerfully versatile software unites and coordinates information, activities and documentation in one reliable enterprise system, effectively managing any quality-, risk- or compliance-related operations.

http://www.assetsmart.com/

http://www.assurx.com/




Baytek International

Website: http://www.baytekinternational.com/

Contact: Walter McNeil


Phone : +(361) 887-8988

HQ: 401 North Shoreline Blvd, Corpus Christi, TX 78401




Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,

North America

Primary Industries: Chemicals, Computer Hardware, Software, Networking,

Cosmetics, Food & Beverages, Industrial Automation, Information Technology

& Services, Oil, Gas, Renewables & Energy, Pharmaceuticals, Plastics,

Utilities, Wine & Spirits

Solutions Offered: Laboratory Information Management (LIMS, LIS, LES). Product

(Batch/Lot) Quality Release, Sample Management, Statistical Process Control

(SPC), Training Management


License Type: 3rd Party Hosted, SaaS (multi-tenant), SaaS (single tenant), On-Premise

VortalBLISS, Baytek International's all web LIMS for the Chemical, Refining, Petrochemical, Water,

and Pharmaceutical process industries. Innovative architecture and leading technology shortens

implementation time, reduces cost, and provides zero footprint workstation and rugged security.

Enterprise Product Spec Management offers secure web interface and integrated automation.

iPRO offers instrument interface for all types of instruments: GC, GC/MS, etc.. TurboTube offers

patented vial distribution for the entire laboratory. BayID offers advanced RFID sample tracking for

exact time/location sample collecting. Ask about our Award Winning 24-7 Support.

CAMA Software, LLC

Website: http://camasoftware.com/

Contact: Carl KernEmail: [email protected] Phone : +949 766-1607

HQ: 19 Gingham St. Suite 100, Trabuco Canyon, CA 92679

Facts: Number of employees: 1-50Years in Business, Since: 2001Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Electrical & Electronic Manufacturing, Food & Beverages, Industrial Automation, Logistics & Supply Chain, Machinery, Medical Device, Packaging & Containers, Pharmaceuticals, Plastics

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise

QCBD’s software suite is an affordable and fully integrated Quality Management Software for managing all your quality system data. Designed specifically for manufacturing companies, QCBD dramatically reduces the cost of achieving and maintaining compliance to quality management. Manage Standards ISO 9001, ISO 13485, AS9100, TS 16949 and SQF 2000 / ISO 22000.

http://www.baytekinternational.com/

http://camasoftware.com/




CEBOS

Website: www.cebos.com

Contact: Bob HerdoizaEmail: [email protected] : +820.534.2222

HQ: 5936 Ford Court Suite 203, Brighton, MI 48116

Facts: Number of employees: 51-200Years in Business, Since: 1995Annual Revenue: 101-500MGeographic Regions: Asia Pac, Europe, Latin America, North AmericaPrimary Industries: Automotive, Biotechnology, Chemicals, Food & Beverages, Furniture, Medical Device, Pharmaceuticals, Plastics, Railroad Manufacturing, Semiconductors, Telecommunications

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Product (Batch/Lot) Quality Release, Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Sample Management, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (single tenant)

Compliance Control Ltd.

Website: WWW.COMPLIANCE-CONTROL.COM

Contact: David ForrestEmail: [email protected] : +44 1606871113

HQ: Winnington Hall, Winnington, Northwich, Cheshire CW8 2AS United Kingdom

Facts: Number of employees: 1-50Years in Business, Since: 2006Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverages, Hospital & Health Care, Information Technology & Services, Medical Device, Pharmaceuticals

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality Risk Management, Training Management

FDA 21 Part 11 Compliant: YesLicense Type: SaaS (multi-tenant)

The system is an ISPE GAMP 3 Categorized system, which means for clients that need a formally validated system in line with MHRA/FDA, etc.. requirements ComplianceControl Centre can be up and running and formally validated within 4,5 days ! For lesser regulated clients, users can be up and running within 1 hour.

http://www.cebos.com/

http://www.compliance-control.com/




ComplianceQuest

Website: www.compliancequest.com

Contact: Jack ThomasEmail: [email protected] : +408-458-8343

HQ: United States

Facts: Number of employees: 1-50Years in Business, Since: 2014Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, North AmericaPrimary Industries: Automotive, Biotechnology, Chemicals, Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Electrical & Electronic Manufacturing, Industrial Automation, Medical Device, Package/Freight Delivery, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Railroad Manufacturing, Semiconductors, Tobacco, Transportation/Trucking/Railroad, Warehousing, Wholesale, Wine & Spirits

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Social Collaboration, Reporting & Analytics


Our solution is built using Force.com technologies. We are the only solution in the EQMS space that has an enterprise grade solution and running on an enterprise grade multi-tenant oriented cloud platform. Furthermore, we have a very strong mobile strategy. All of the solutions we offer has a mobile component and allows to access, view, approve, create records using Mobile. This would also be a industry first.

CyberMetrics Corporation

Website: http://www.cybermetrics.com

Contact: Chris Richardson


Phone : +1-800-777-7020

HQ: 1523 W. Whispering Wind Drive Suite 100, Phoenix, AZ 85085




Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle

East, North America

Primary Industries: All industries

Solutions Offered: Equipment Calibration & Maintenance Management,

Quality Risk Management, Supplier Quality Management (contract

services - CMOs, CROs, etc..)


License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd

Party Hosted

http://www.compliancequest.com/

http://www.cybermetrics.com/




DataLyzer International

Website: www.datalyzer.com

Contact: John HallEmail: [email protected] : +248-960-3535

HQ: 29445 Beck Road, A207, Wixom, MI 48393

Facts: Number of employees: 1-50Years in Business, Since: 1979Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Biotechnology, Building Materials, Chemicals, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Food & Beverages, Glass, Ceramics & Concrete, Machinery, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Railroad Manufacturing, Semiconductors, Tobacco, Wine & Spirits

Solutions Offered: APQP (Advanced Product Quality Planning), CAPA Management, Equipment Calibration & Maintenance Management, Inspection Management (raw material, parts, components), Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Sample Management, Statistical Process Control (SPC), Supplier Quality Management (contract services - CMOs, CROs, etc..), OEE, FMEA, MSA


Available in 18 languages, offices in USA, Europe and Asia and experienced distributors in major countries

Dimensional Control Systems

Website: www.3dcs.com

Contact: Benjamin ReeseEmail: [email protected] : +2482699777

HQ: 580 Kirts Blvd, Suite 309, Troy, MI 48084

Facts: Number of employees: 51-200Years in Business, Since: 1994Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, Latin America, North AmericaPrimary Industries: Automotive, Consumer Electronics, Goods, Services, Defense & Space/Military, Electrical & Electronic Manufacturing, Machinery, Medical Device, Oil, Gas, Renewables & Energy

Solutions Offered: APQP (Advanced Product Quality Planning), Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Root Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..)


Dimensional Control Systems (DCS) is an engineering services and software provider. We provide QDM, our QMS system, as well as 3DCS, our CAD based simulation tool, as well as services which can provide a customer a short term proof of concept or case study to demonstrate value of the products. We have a global partner network to provide support in all of our serviced regions.

http://www.datalyzer.com/

http://www.3dcs.com/




DocXellent

Website: www.docxellent.com

Contact: Gary CarignanEmail: [email protected] : +860-887-2900

HQ: 257 Main Street, Norwich, CT 06360

Facts: Number of employees: 1-50Years in Business, Since: 1983Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Cosmetics, Education Management/E-learning, Electrical & Electronic Manufacturing, Food & Beverages, Gambling & Casinos, Hospital & Health Care, Industrial Automation, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Pharmaceuticals, Semiconductors, Telecommunications, Utilities

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Product (Batch/Lot) Quality Release, Quality Risk Management, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (single tenant), 3rd Party Hosted

EMNS, Inc.

Website: www.gsqa.com

Contact: John McGlinnEmail: [email protected] : +888.900.5033

HQ: 2815 Centre Circle Dr., Downers Grove, IL 60515

Facts: Number of employees: 1-50Years in Business, Since: 2001Annual Revenue: Privately HeldGeographic Regions: North AmericaPrimary Industries: Building Materials, Chemicals, Consumer Electronics, Goods, Services, Defense & Space/Military, Electrical & Electronic Manufacturing, Food & Beverages, Glass, Ceramics & Concrete, Machinery, Mining & Metals, Oil, Gas, Renewables & Energy, Packaging & Containers, Paper & Forest Products, Plastics, Railroad Manufacturing, Semiconductors, Supermarkets, Telecommunications, Tobacco, Transportation/Trucking/Railroad, Wine & Spirits

Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Electronic Laboratory Notebook (ELN), Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Laboratory Information Management (LIMS, LIS, LES), Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release, Quality Risk Management, Sample Management, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services -CMOs, CROs, etc..)

FDA 21 Part 11 Compliant: NoLicense Type: SaaS (single tenant), SaaS (multi-tenant)

http://www.docxellent.com/

http://www.gsqa.com/




E Squared UK Ltd

Website: www.isoma.systems

Contact: David KeyEmail: [email protected]

HQ: 2 Wellington Place, Leeds LS1 4AP United Kingdom

Facts: Number of employees: 1-50Years in Business, Since: 2008Annual Revenue: 1-25MGeographic Regions: Asia Pac, Europe, Middle East, North AmericaPrimary Industries: Automotive, Construction, Defense & Space/Military, Electrical & Electronic Manufacturing, Logistics & Supply Chain, Telecommunications

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Document Management, EHS (Environmental, Health & Safety) Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release, Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Sample Management, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..)

FDA 21 Part 11 Compliant: NoLicense Type: On-Premise, SaaS (multi-tenant), 3rd Party Hosted

Isoma is enterprise software for building and operating Integrated Management Systems. Designed for standards management professionals by standards management professionals it generates insight, drives improvement and refocuses organizations.

Fast Track (Aust) Pty Ltd

Website: www.fasttrack365.com

Contact: Greg CarrollEmail: [email protected]

HQ: Level 4, 50 Marine Pde, Southport, QLD 2415 Australia

Facts: Number of employees: 1-50Years in Business, Since: 1981Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Middle EastPrimary Industries: Defense & Space/Military, Gambling & Casinos, Hospital & Health Care, Mining & Metals, Utilities, Govt Administration

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Product (Batch/Lot) Quality Release, Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Governance - Objectives, KPIs, Obligations, Strategic Planning

FDA 21 Part 11 Compliant: Not assessedLicense Type: On-Premise, SaaS (single tenant)

For 30 years Fast Track has specialized in regulatory compliance and enterprise risk management for medium and large organizations, providing enterprise solutions for Quality, Risk, Contract and Asset Management. Clients include Aust Dept of Defence, Motorola, Serco as well as Utilities and Healthcare industries. Privately owned, based on the Gold Coast, Australia looking after clients as far afield as Mali and Colombia. Founded 1981, throughout our longevity our products and services have remained industry leading, as we are still looking after the likes of Fosters and Motorola since the early nineties attests. Positioned in the mission critical marketplace and aimed at those pursuing best practices, our product is about providing insight and decision making support proactively instead of the traditional record administration approach.

http://www.isoma.systems/

mailto:[email protected]

http://www.fasttrack365.com/

mailto:[email protected]




Formpipe Software AB (Formpipe.GxP)

Website: www.formpipegxp.com

Contact: Keith WilliamsEmail: [email protected] : +44 115 924 8475

HQ: 13 Populars Court, Lenton Lane, Nottingham NG7 2RR

Facts: Number of employees: 201-500Years in Business, Since: 1999Annual Revenue: 1-25MGeographic Regions: Europe, North AmericaPrimary Industries: Biotechnology, Hospital & Health Care, Medical Device, Pharmaceuticals

Solutions Offered: Audit Management (Internal/External), CAPA Management, Document Management, Quality Risk Management, Supplier Quality Management (contract services - CMOs, CROs, etc.), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted

Formpipe.GxP, the Life Science division of Formpipe Software AB, simplify complex process and technology environments to help Life Science organizations achieve their compliance goals. We achieve this through a combination of EQMS Solutions and Compliance Consultancy that enable our customers to ‘Get Compliant’ and ‘Stay Compliant’. Founded in 1999, the company has successfully delivered over 350 compliance based projects within the EU and US regulatory landscape. Formpipe.GxP works with 12 of the top 20 leading global organizations to help them Stay Compliant with offices in the US, Sweden and the UK. Parent company Formpipe Software AB develops ECM products and solutions for structuring information and supplies them to major companies, authorities and organizations. ECM products help organizations to capture, manage and distribute information, and to place it in context. The company's software helps improve efficiency, cut costs and reduce risk exposure. Formpipe was founded in 2004 and has offices in Stockholm, Uppsala and Linköping in Sweden, and in Copenhagen, Denmark. The Formpipe share is listed on NASDAQ OMX Nordic

Gael Limited (Q-Pulse)

Website: www.gaelquality.com

Contact: Tony McCutcheonEmail: [email protected] : +01355 593 400

HQ: Orion House S.E. Technology Park, East Kilbride, South Lanarkshire G75 0RD Scotland

Facts: Number of employees: 51-200Years in Business, Since: 1992Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Computer Hardware, Software, Networking, Defense & Space/Military, Education Management/E-learning, Hospital & Health Care, Industrial Automation, Information Technology & Services, Logistics & Supply Chain, Medical Device, Pharmaceuticals, Transportation/Trucking/Railroad, Other (please specify) Aviation & Rail

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Laboratory Information Management (LIMS, LIS, LES), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Risk Management Compliance Management


http://www.formpipegxp.com/

http://www.gaelquality.com/





Website: www.grandavenue.com

Contact: Ron Schmitz


Phone : +651-204-1743

HQ: 180 5th St E Suite 256, Saint Paul, MN 55101




Geographic Regions: Asia Pac, Europe, Latin America, North America

Primary Industries: Medical Device

Solutions Offered: Audit Management (Internal/External), CAPA

Management, Change Control Management, Complaints (Product

Quality, Technical), Document Management, Equipment Calibration

& Maintenance Management, Training Management


License Type: On-Premise, 3rd Party Hosted

greenight.guru

Website: www.greenlight.guru

Contact: Nick TippmannEmail: [email protected] : +260-438-8708

HQ: 1060 N. Capitol Ave Suite C100, Indianapolis, IN 46204

Facts: Number of employees: 1-50Years in Business, Since: 2013Annual Revenue: Privately HeldGeographic Regions: Europe, North AmericaPrimary Industries: Computer Hardware, Software, Networking, Information Technology & Services, Medical Device

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management


http://www.grandavenue.com/





Website: http://www.hgint.com

Contact: Tom QuinnEmail: [email protected] : +256-451-3508

HQ: 111501 Lake Underhill Road, Orlando, FL 32825

Facts: Number of employees: 1-50Years in Business, Since: 1991Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Biotechnology, Building Materials, Chemicals, Computer Hardware, Software, Networking, Construction, Defense & Space/Military, Electrical & Electronic Manufacturing, Environmental/Facilities Services, Food & Beverages, Furniture, Hospital & Health Care, Hospitality, Industrial Automation, Information Technology & Services, Logistics & Supply Chain, Machinery, Maritime/Shipbuilding, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Package/Freight Delivery, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Semiconductors, Telecommunications, Transportation/Trucking/Railroad, Utilities, Warehousing, Wholesale

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management


Complete QMS & Supplier Quality Management Software Solutions & Consulting Services

HyperTeam USA Inc.

Website: www.hyperteam.com

Contact: Arpad Solti


Phone : +2396879806

HQ: 5841 Cinzano Ct, Naples, FL 34119



Annual Revenue: 1-25M

Geographic Regions: Europe, North America

Primary Industries: Banking, Biotechnology, Chemicals, Financial

Services, Information Technology & Services, Insurance, Logistics &

Supply Chain, Medical Device, Pharmaceuticals, Retail, Utilities

Solutions Offered: Complaints (Product Quality, Technical), Document

Management, Product (Batch/Lot) Quality Release, Supplier Quality

Management (contract services - CMOs, CROs, etc..), Complaint

Handling SharePoint Solution Policy & Regulation Manager

SharePoint Solution


License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd

Party Hosted

http://www.hgint.com/

http://www.hyperteam.com/




iBASEt

Website: www.ibaset.com

Contact: Conrad Leiva


Phone : +949-598-5200

HQ: 27442 Portola Pkwy #300, Foothill Ranch, CA 92688




Geographic Regions: Europe, North America

Primary Industries: Defense & Space/Military, Electrical & Electronic

Manufacturing, Industrial Automation, Logistics & Supply Chain, Machinery,

Medical Device, Railroad Manufacturing, Transportation/Trucking/Railroad

Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management

(Internal/External), CAPA Management, Change Control Management,

Equipment Calibration & Maintenance Management, Exception Management

(deviations, nonconformances, OOS, OOT, events), Inspection Management

(raw material, parts, components), Quality Risk Management, Root

Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC),

Supplier Collaboration, Supplier Quality Management (contract services -

CMOs, CROs, etc..), Work Instructions, Engineering and ERP Integration



INFOTEHNA

Website: www.infotehna.com

Contact: Sonja VlasicEmail: [email protected] : +38673930600

HQ: Podbreznik 15, Novo mesto 8000 Slovenija

Facts: Number of employees: 51-200Years in Business, Since: 1988Annual Revenue: 1-25MGeographic Regions: Asia Pac, Europe, Middle East, North AmericaPrimary Industries: Biotechnology, Medical Device, Pharmaceuticals

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Product (Batch/Lot) Quality Release, Supplier Quality Management (contract services - CMOs, CROs, etc..), Validation


INFOTEHNA is a major provider of the most advanced solutions for managing regulatory data, documents and processes in the global life sciences industry. Our myPharma Expert Suite of solutions enables standardization across enterprises and helps users tackle RA, RIM including Publishing and Submissions management, R&D, QA/QC, PhV and Manufacturing challenges. Depending on organizations' specific needs, our solution can be modular or integral, and is thus capable of supporting singular compliance relevant processes or complete enterprise compliance management. Also, it can be deployed on premises or cloud. By using INFOTEHNA's product, our clients reduce the time to market for new products and the overall Product Life Cycle Management effort. Even more importantly, they introduce sustainable compliance as there is no need to maintain integration between multiple systems. Our myPharma Expert Suite of solutions is easily configurable and validated and its use increases the overall quality of products, documents, data and processes. We have an exceptional track record consisting of 25 years of compliance solutions and products for the Life Sciences industry globally

http://www.ibaset.com/

http://www.infotehna.com/




Integrum Management Systems Pty Limited

Website: www.integrumsystems.com

Contact: Beven SchwaigerEmail: [email protected] : +61 2 9663 1004

HQ: Suite 13 6-8 Crewe Place, Rosebery NSW 2018 Australia

Facts: Number of employees: 1-50Years in Business, Since: 1996Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Banking, Building Materials, Chemicals, Construction, Consumer Electronics, Goods, Services, Defense & Space/Military, Education Management/E-learning, Electrical & Electronic Manufacturing, Environmental/Facilities Services, Financial Services, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Hospital & Health Care, Hospitality, Industrial Automation, Information Technology & Services, Insurance, Logistics & Supply Chain, Machinery, Maritime/Shipbuilding, Mining & Metals, Oil, Gas, Renewables & Energy, Package/Freight Delivery, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Publishing, Railroad Manufacturing, Retail, Supermarkets, Telecommunications, Transportation/Trucking/Railroad, Utilities, Warehousing, Wholesale, Aviation, Waste & Water

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Complaints (Product Quality, Technical), Document Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Legal Compliance Management


Since 1996, over 250,000 licensed users in over 40 countries

IQS, Inc.

Website: www.iqs.com

Contact: Karleen RadkeEmail: [email protected] : +4407882725

HQ: 24950 Country Club Blvd #120, North Olmsted, OH 44070

Facts: Number of employees: 1-50Years in Business, Since: 1988Annual Revenue: Privately HeldGeographic Regions: Europe, Latin America, North AmericaPrimary Industries: Automotive, Defense & Space/Military, Medical Device, Oil, Gas, Renewables & Energy, Plastics

Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Inspection Management (raw material, parts, components), Quality Risk Management, Statistical Process Control (SPC), Supplier Collaboration, Training Management, Calibration Mgmt, Equipment Mtce, FMEA/Control Plan Mgmt, PPAP/First Article Mgmt, Inspection/SPC, Analytics


IQS provides the most comprehensive and user-friendly quality management software system on the market. IQS stands out in these key areas: -Quality management through the supply chain with a scalable, enterprise-wide structure -User-friendly, flexible, configurable quality software -Robust systems integration capabilities -Configurable quality analytics, dash boarding and reporting -Expert and proven implementation and technical support

http://www.integrumsystems.com/

http://www.iqs.com/




MasterControl

Website: www.mastercontrol.com

Contact: Jeff Parr


Phone : +801-541-9668

HQ: 6330 South 3000 East Suite 200, Salt Lake City, UT 84121



Annual Revenue: 26-50M

Geographic Regions: Asia Pac, Europe, North America

Primary Industries: Biotechnology, Chemicals, Food & Beverages, Hospital &

Health Care, Logistics & Supply Chain, Medical Device, Oil, Gas, Renewables

& Energy, Packaging & Containers, Pharmaceuticals, Tobacco

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA

Management, Change Control Management, Complaints (Product Quality,

Technical), Document Management, Equipment Calibration & Maintenance

Management, Exception Management (deviations, nonconformances, OOS,

OOT, events), Inspection Management (raw material, parts, components),

Product (Batch/Lot) Quality Release, Quality By Design (QbD), Quality Risk

Management, Root Cause/Failure Mode Analysis Tools, Supplier

Collaboration, Supplier Quality Management (contract services - CMOs, CROs,

etc..), Training Management


License Type: On-Premise, SaaS (single tenant)

Meercat Pty Ltd

Website: www.meercat.com.au

Contact: Alex ApostolouEmail: [email protected] : +61407779879

HQ: Unit 1 362 Fitzgerald Street, North Perth, WA 6006 Australia

Facts: Number of employees: 1-50Years in Business, Since: 2002Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, North AmericaPrimary Industries: Building Materials, Chemicals, Environmental/Facilities Services, Logistics & Supply Chain, Maritime/Shipbuilding, Mining & Metals, Oil, Gas, Renewables & Energy, Package/Freight Delivery, Packaging & Containers, Paper & Forest Products, Utilities

Solutions Offered: Exception Management (deviations, nonconformances, OOS, OOT, events), Root Cause/Failure Mode Analysis Tools, Risk Management, Bowtie visualization, qualitative and quantitative analysis, control assurance, action tracking, auditing and data analysis.

License Type: On-Premise, SaaS (single tenant)

RiskView supports the Operational Risk Management process of identifying, analyzing and managing operational risk and enables businesses to integrate risk data into a single environment. This integrated approach helps improve visibility into risk exposure, reduce loss and improve business performance. RiskView provides: Single Repository for all Risk Data Enables unlimited levels of entities, processes, risks and controls to match the structure of your organization Eliminates redundancies through shared documents, processes, risks and controls Scenario analysis Provides document management with audit trail capabilities Enables business units to assess high-impact risk areas and emerging risks Risk indicator tracking Enables you to track risk metrics and thresholds Supports proactive management of key risks to improve corporate performance Business intelligence and decision support Provides browser-based reporting capabilities Delivers reporting on the current state of operational risk across the organization Lets you drill down through reports for root cause analysis Loss event tracking Offers statistical and trend analysis capabilities to enable tracking of remedies and action plans Improves risk measurement and helps minimize losses RiskView allows you to embed operational risk management practices into the corporate culture, making procedures more effective and efficient.

http://www.mastercontrol.com/

http://www.meercat.com.au/




MOTTO Systems Pvt Ltd.

Website: http://www.quickgmp.com/

Contact: RAJ KEmail: [email protected] : +09553444478

HQ: 1ST FLOOR, SAMRIDHI VASYAM, JAIHIND ENCLAVE, MADHAPUR, HYDERABAD TG, 500081, India

Facts: Number of employees: 1-50Years in Business, Since: 2013Annual Revenue: 1-25MGeographic Regions: Asia Pac, North AmericaPrimary Industries: Education Management/E-learning, Information Technology & Services, Mining & Metals, Pharmaceuticals

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Electronic Laboratory Notebook (ELN), Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Laboratory Information Management (LIMS, LIS, LES), Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release, Root Cause/Failure Mode Analysis Tools, Sample Management, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Stability Management Recall and Return Management


A flagship product from Motto Systems, GMPPro is an end to end solution for Life Science companies. A complete Web based Quality Management System that facilitates efficient management of Process capabilities, Regulatory and Quality compliance and documentation with proper cGMP and Quality guidelines. GMPPro is well fit for Life Sciences, Pharmaceutical and Food manufacturing Industries.

Neomatics (ExpressPack Quality)

Website: www.neomatics.be

Contact: Sven MusEmail: [email protected] : +32 477 56 28 36

HQ: Kattendijkdok Westkaai 53 T2 3.1, Antwerp 2000 Belgium

Facts: Number of employees: 51-200Years in Business, Since: 2000Annual Revenue: 1-25MGeographic Regions: Europe, North AmericaPrimary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverages, Hospital & Health Care, Machinery, Medical Device, Package/Freight Delivery, Packaging & Containers, Pharmaceuticals

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, non-conformances, OOS, OOT, events), Quality By Design (QbD), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Validation GxP & ISO, e.g. 15189

FDA 21 Part 11 Compliant: Yes License Type: 3rd Party Hosted, SaaS (single tenant), On-Premise

We provide both the software solution and services. The services include non software related items such as QA's, QP's, Tech transfer and Validation.

http://www.quickgmp.com/

http://www.neomatics.be/




Omnify Software

Website: http://www.omnifysoft.com

Contact: Alaine PortnoyEmail: [email protected] : +9789883800

HQ: 2 Highwood Drive Suite 202, Tewksbury, MA 01876

Facts: Number of employees: 1-50Years in Business, Since: 2002Annual Revenue: Privately HeldGeographic Regions: Europe, North AmericaPrimary Industries: Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Defense & Space/Military, Electrical & Electronic Manufacturing, Medical Device, Semiconductors, Telecommunications

Solutions Offered: CAPA Management, Change Control Management, Document Management, Equipment Calibration & Maintenance Management, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Product Lifecycle Management (PLM), Bill of Material (BOM) Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, 3rd Party Hosted

The Omnify Empower PLM solution provides a single location to track and manage all product content information. By encompassing Quality Management, customers can also associate quality information/processes to the product record which helps to address quality issues early on, provides visibility into quality issues across the entire organization and eliminates the need for two separate databases (Quality and PLM).

PSC Software

Website: www.pscsoftware.com

Contact: John ClaphamEmail: [email protected] : +9097843350

HQ: 700 Corporate Center Drive Suite 201, Pomona, CA

Facts: Number of employees: 201-500Years in Business, Since: 1996Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Banking, Biotechnology, Chemicals, Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Education Management/E-learning, Environmental/Facilities Services, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Hospital & Health Care, Hospitality, Industrial Automation, Information Technology & Services, Insurance, Logistics & Supply Chain, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Restaurants, Retail, Transportation/Trucking/Railroad, Utilities, Wine & Spirits

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Product (Batch/Lot) Quality Release, Quality Risk Management, Sample Management, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management


We offer a complete validation package for our software, additionally we do document control, and full work engine functionality.

http://www.omnifysoft.com/

http://www.pscsoftware.com/





Website: www.pilgrimquality.com

Contact: Patrice CunninghamEmail: [email protected] : +8139151663 x2502

HQ: 2807 W. Busch Blvd, Tampa, FL 33549

Facts: Number of employees: 51-200Years in Business, Since: 1993Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Cosmetics, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Pharmaceuticals, Tobacco, Blood & Tissue

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Quality Risk Management, Supplier Quality Management (contract services -CMOs, CROs, etc..), Training Management


PTC

Website: www.ptc.com

Contact: Daniel JacobEmail: [email protected] : +724-953-4853

HQ: 140 Kendrick St, Needham, MA 02494

Facts: Number of employees: 5000+Years in Business, Since: 1985Annual Revenue: 1B+Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Computer Hardware, Software, Networking, Construction, Consumer Electronics, Goods, Services, Defense & Space/Military, Electrical & Electronic Manufacturing, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Hospital & Health Care, Industrial Automation, Information Technology & Services, Logistics & Supply Chain, Machinery, Maritime/Shipbuilding, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Pharmaceuticals, Plastics, Retail, Semiconductors, Telecommunications, Transportation/Trucking/Railroad

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality By Design (QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, PLM, Service Management, IoT, Regulatory Management (REACH/RoHS, Conflict Minerals, etc.), UDI Management, Requirements Management, Software Management, Manufacturing Process Management, Reliability and Safety Management, Systems Engineering, CAD/CAM/CAE


PTC delivers technology solutions that transform the way you create and service products; cutting costs, reducing risk, and driving growth. Serving 6 continents and over 28,000 customers. PTC is an award winning leader in the Internet of Things.

http://www.pilgrimquality.com/

http://www.ptc.com/




Quality Institute of America (QAI)

Website: www.qisssoftware.com

Contact: Aziz WaqarEmail: [email protected] : +281-335-7979 Ext 2#

HQ: 8951 Ruthby, Suite 12, Houston, TX 77061

Facts: Number of employees: 1-50Years in Business, Since: 1996Annual Revenue: Privately HeldGeographic Regions: Asia Pac, North AmericaPrimary Industries: Automotive, Chemicals, Cosmetics, Electrical & Electronic Manufacturing, Industrial Automation, Information Technology & Services, Insurance, International Trade & Development, Logistics & Supply Chain, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Retail, Warehousing, Wholesale

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Laboratory Information Management (LIMS, LIS, LES), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: NoLicense Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted

We also Provide QMS internal Audit Training and do QMS Internal Audits. We also provide Consulting services in ISO and API standards.

QMSrs

Website: http://www.qmsrs.com/qmsrsweb

Contact: Bassam ZaidanEmail: [email protected] : +00966566805119

HQ: 141 Cutenhoe Road, Luton, Beds LU1 3NG

Facts: Number of employees: 1-50Years in Business, Since: 2007Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Europe, Middle East, North AmericaPrimary Industries: All industries

Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC), Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: NoLicense Type: 3rd Party Hosted, SaaS (multi-tenant), SaaS (single tenant), On-Premise

http://www.qisssoftware.com/

http://www.qmsrs.com/qmsrsweb




Rescop

Website: www.rescop.com

Contact: P. VervoortEmail: [email protected] : +31633909050

HQ: Luchthavenweg 81 unit 0.41, Eindhoven Noord Brabant 5657EA Netherlands

Facts: Number of employees: 51-200Years in Business, Since: 2005Annual Revenue: 1-25MGeographic Regions: Europe, North AmericaPrimary Industries: Biotechnology, Medical Device, Pharmaceuticals, Tobacco

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Document Management, Electronic Laboratory Notebook (ELN), Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Laboratory Information Management (LIMS, LIS, LES), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, SLM, PQR, CQV, E-logbook, EBR, Validation and Compliance consultancy services.


License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted

Security and installation 21 CFR Part 11 compliance. also sizeable for small to medium sized companies. International track record.


Website: www.qualitysystems.com

Contact: Ian ClarkEmail: [email protected] : +61 410 747 069

HQ: 12 Panoramic Drive, Narangba, Queensland 4504

Facts: Number of employees: 1-50Years in Business, Since: 2001Annual Revenue: Privately HeldGeographic Regions: Asia Pac, EuropePrimary Industries: Construction, Consumer Electronics, Goods, Services, Environmental/Facilities Services, Hospital & Health Care, Machinery, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Packaging & Containers, Plastics, Utilities

Solutions Offered: Audit Management (Internal/External), CAPA Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Training Management, Risk Management, Records Management

FDA 21 Part 11 Compliant: NoLicense Type: SaaS (single tenant)

http://www.rescop.com/

http://www.qualitysystems.com/




ReSol Technologies

Website: www.ReSolSystems.com

Contact: Dmitriy IzbinskyEmail: [email protected] : +2673423548

HQ: Southampton, PA 18966

Facts: Number of employees: 1-50Years in Business, Since: 2005Annual Revenue: 1-25MGeographic Regions: Asia Pac, Europe, North AmericaPrimary Industries: Automotive, Biotechnology, Chemicals, Computer Hardware, Software, Networking, Education Management/E-learning, Environmental/Facilities Services, Information Technology & Services, Medical Device, Pharmaceuticals, Tobacco, Utilities

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Electronic Laboratory Notebook (ELN), Exception Management (deviations, nonconformances, OOS, OOT, events), Product (Batch/Lot) Quality Release, Quality Risk Management, Training Management


SoftExpert Software

Website: www.softexpert.com

Contact: Marco HintzEmail: [email protected] : +554721019099

HQ: Tijucas, 151, Joinville SC 89204020, Brazil

Facts: Number of employees: 51-200Years in Business, Since: 1995Annual Revenue: 26-50MGeographic Regions :Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Automotive, Banking, Biotechnology, Building Materials, Chemicals, Construction, Consumer Electronics, Goods, Services, Defense & Space/Military, Education Management/E-learning, Electrical & Electronic Manufacturing, Environmental/Facilities Services, Financial Services, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Hospital & Health Care, Hospitality, Import & Export, Industrial Automation, Information Technology & Services, Logistics & Supply Chain, Maritime/Shipbuilding, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Paper & Forest Products, Pharmaceuticals, Plastics, Railroad Manufacturing, Retail, Semiconductors, Telecommunications, Transportation/Trucking/Railroad, Utilities, Warehousing, Wholesale

Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Product (Batch/Lot) Quality Release, Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management


SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

http://www.resolsystems.com/

http://www.softexpert.com/




SOLABS

Website: www.solabs.com

Contact: Ericka MooreEmail: [email protected] : +508-620-5306

HQ: 945 Concord Street, Framingham, MA 01701

Facts: Number of employees: 1-50Years in Business, Since: 1999Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Hospital & Health Care, Medical Device, Pharmaceuticals

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Product (Batch/Lot) Quality Release, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management


SOLABS is dedicated to exclusively serving the needs of the Life Sciences Industry. We are passionate about quality automation! We help our clients transition from manual and often paper-based quality operations to automated, controlled and more efficient operations. Our solution SOLABS QM offers an integrated approach where the entire Quality Management System can be managed in a single application. Our internal implementation team provides a complete range of services including project management, extensive validation, on-site training, configuration to meet the client's specific requirements and data migration to ensure a quick and full implementation. Our unique pricing model allows for most of our clients to extend the use of SOLABS QM to all of their employees. We have users all over the world including North-America, Europe and Asia and our solution is available in various languages. Most of our clients are subject to regular inspections and audits by the FDA and other regulatory agencies. Finally, our technology allows us to be able to provide future clients with a personalized web-based trial of SOLABS QM in a matter of hours.

Sparta Systems, Inc. (Trackwise)

Website: www.spartasystems.com

Contact: Colleen NugentEmail: [email protected] : +609-807-5226

HQ: 2000 Waterview Drive Suite 300, Hamilton, NJ 08691

Facts: Number of employees: 201-500Years in Business, Since: 1994Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Chemicals, Consumer Electronics, Goods, Services, Cosmetics, Electrical & Electronic Manufacturing, Food & Beverages, Glass, Ceramics & Concrete, Industrial Automation, Logistics & Supply Chain, Medical Device, Pharmaceuticals, Semiconductors, Tobacco, Wine & Spirits

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Exception Management (deviations, nonconformances, OOS, OOT, events), Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release, Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality Management (contract services -CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (multi-tenant), 3rd Party Hosted

http://www.solabs.com/

http://www.spartasystems.com/




Traction Software

Website: www.tractionsoftware.com

Contact: Jordan FrankEmail: [email protected] : +401-528-1145 x12

HQ: 245 Waterman Street Suite 504, Providence, RI 02906

Facts: Number of employees: 1-50Years in Business, Since: 1996Annual Revenue: Privately HeldGeographic Regions: Africa, Asia Pac, Europe, North AmericaPrimary Industries: All industries

Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality Risk Management, Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management

FDA 21 Part 11 Compliant: NoLicense Type: On-Premise, SaaS (single tenant)

TeamPage is an Enterprise 2.0 Social Software platform with wiki authoring and tasking facilities with display, search, moderation and audit trail facilities that are ideal for Quality Management documentation and key action tracking (non-conformance, corrective action and so on). The software can be setup for teams to create spaces for shift logs, shift issue tracking and standard meeting agendas + follow-up. The TeamPage Quality Module adds a Quality Dashboard to post and track Issues/Feedback, Non Conformance and Corrective/Preventive Actions. For the LEAN minded organization, TeamPage also has module extensions for Continuous Improvement Ideas and Improvement Projects.

Techmentis Global Services Ptv Ltd (FlinkISO Open Source)

Website: www.flinkiso.com

Contact: Mayuresh Vaidya


Phone : +91 9820567801

HQ: 103, Corporate Corner, Sunder Nagar, Malad West Mumbai MH 400064

India




Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle

East, North America

Primary Industries: All industries

Solutions Offered: Audit Management (Internal/External), CAPA

Management, Change Control Management, Document

Management, Equipment Calibration & Maintenance Management,

Training Management


License Type: Free Open Source

http://www.tractionsoftware.com/

http://www.flinkiso.com/




uniPoint Software Inc.

Website: www.unipointsoftware.com

Contact: Dean M. AntonakesEmail: [email protected] : +905-509-8443

HQ: 1425 Whyte Avenue, Winnipeg MB R3E 1V7 Canada

Facts: Number of employees: 1-50Years in Business, Since: 2002Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, North AmericaPrimary Industries: Automotive, Biotechnology, Chemicals, Defense & Space/Military, Electrical & Electronic Manufacturing, Food & Beverages, Machinery, Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics, General Manufacturing, Aerospace

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Inspection Management (raw material, parts, components), Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Sample Management, Statistical Process Control (SPC), Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs, etc..), Training Management, Validation, Trending, Benchmarking, Key Performance Indicators, Surveys, Knowledge Base


uniPoint is the industry leader in ERP-Integrated Quality Management Software, offering standard integrations to over 30 leading ERP systems.

UL Eduneering

Website: www.uleduneering.com

Contact: Robert SimsEmail: [email protected] : +609-627-5320

HQ: 202 Carnegie Center Suite 301, Princeton, NJ 08540

Facts: Number of employees: 51-200Years in Business, Since: 1981Annual Revenue: Privately HeldGeographic Regions: Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: Biotechnology, Building Materials, Chemicals, Construction, Consumer Electronics, Goods, Services, Cosmetics, Environmental/Facilities Services, Food & Beverages, Hospital & Health Care, Industrial Automation, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Packaging & Containers, Pharmaceuticals, Tobacco, Utilities

Solutions Offered: Supplier Collaboration, Training Management, EduNetwork (Supplier Collaboration), Off-the-Shelf eLearning Libraries, Skills Gap Mapping Consulting, Software Validation Consulting


As part of UL, we also provide compliance eLearning courses, spanning GMP, FDA Enforcement, global regulatory submissions, engineering compliance, building code compliance and other topics.

http://www.unipointsoftware.com/

http://www.uleduneering.com/




Verse Solutions

Website: www.versesolutions.com

Contact: Kelly FitzgeraldEmail: [email protected] : +423-388-3777 x381

HQ: 399 Conklin Street, Farmingdale, NY 11735

Facts: Number of employees: 1-50Years in Business, Since: 2011Annual Revenue: 1-25MGeographic Regions: Europe, North AmericaPrimary Industries: Automotive, Biotechnology, Building Materials, Chemicals, Consumer Electronics, Goods, Services, Education Management/E-learning, Electrical & Electronic Manufacturing, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Machinery, Maritime/Shipbuilding, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Package/Freight Delivery, Packaging & Containers, Paper & Forest Products, Plastics, Railroad Manufacturing, Restaurants, Retail, Semiconductors, Supermarkets, Telecommunications, Transportation/Trucking/Railroad, Utilities, Warehousing

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Training Management


Vivaldi Software

Website: www.vivaldisoftware.com

Contact: Sibren MissiaenEmail: [email protected] : +32 56 73 20 20

HQ: Handelscentrum Pottelberg, Engelse Wandeling 2 K02V, Kortrijk West-Vlaanderen 8500 Belgium

Facts: Number of employees: 1-50Years in Business, Since: 1995Annual Revenue: 1-25MGeographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North AmericaPrimary Industries: All industries

Solutions Offered: Audit Management (Internal/External), CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Equipment Calibration & Maintenance Management, Exception Management (deviations, nonconformances, OOS, OOT, events), Quality Risk Management, Training Management

FDA 21 Part 11 Compliant: YesLicense Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant)

http://www.versesolutions.com/

http://www.vivaldisoftware.com/




ZenQMS (formerly The Quality Advisory Board)

Website: www.zenqms.com

Contact: Jeff Thomas


Phone : +1.888.280.1433

HQ: 128 Front St. Suite 100, Conshohocken, PA 19010




Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,

North America

Primary Industries: Biotechnology, Chemicals, Medical Device,

Pharmaceuticals

Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA

Management, Change Control Management, Complaints (Product Quality,

Technical), Document Management, Exception Management (deviations,

nonconformances, OOS, OOT, events), Inspection Management (raw material,

parts, components), Quality Risk Management, Supplier Collaboration,

Supplier Quality Management (contract services - CMOs, CROs, etc..),

Integrated eQMS offering.


License Type: SaaS (multi-tenant)

Our customers love our software and support services.

http://www.zenqms.com/


Audit Calibration CAPAChange Control Complaints

Document Mgmt EHS

Exceptions/Deviations /

NCs LIMS MES PLMSPC / PAT

Supplier Quality Training

123Compliance x x x x x x x

4Sight (GE) x

ABB LIMS x

Accelerys (Dassault Systemes) x

Access Automation x

ActiveQ (Open Mind Solutions) x x x x x

Affytrac (Affygility Solutions) x

Ambrit x

Adaptive BMS x x

Aegis Solutions x x

Agilent x

Agile PLM (Oracle) x x x x x x

Ape Software x

Apollo LIMS (Common Cents Systems) x

Apriso (Dassault Systemes) x

Aras Corp x x x x

Arena Solutions x x x x x x

Argus (Oracle) x

Ariba x

Aris Global x x

ASI Datayte x

ASKEHS Engineering x

AspenTech x

AssessNet x

AssetSmart x

Assure (SHE Software) x

AssurX x x x x x x x x

Audit Utopia x

http://123compliance.com/

https://www.gemeasurement.com/test-calibration/software/4sight-calibration-and-maintenance-software

http://www.abb.com/industries/db0003db002806/c12571f4003208d6c1256f890052f24d.aspx

http://accelrys.com/

http://www.aaplweb.com/

http://open-mind-solutions.com/index.html

http://affytrac.com/

http://www.ambrit.com/index.html

https://adaptivebms.com/

http://www.aiscorp.com/en/

http://www.agilent.com/home

http://www.oracle.com/us/products/applications/agile/overview/index.html

http://www.apesoftware.com/

http://www.apollolims.com/

http://www.apriso.com/

http://www.aras.com/

http://www.arenasolutions.com/

http://www.oracle.com/us/products/applications/health-sciences/safety/argus-safety/index.html

http://www.ariba.com/

https://arisglobal.com/

http://www.en.asidatamyte.com/

http://www.ask-ehs.com/

https://www.aspentech.com/

http://www.assessnet.co.uk/


http://www.shesoftware.com/





Document Mgmt EHS




Audit Weaver x x xAutodesk PLM x xBlaze LIMS (Blaze Systems) xBLISS LIMS (Baytek International) xBLUe-CAT Synergy x x x x x x x xBPLM Solutions GMBH xBreeze Software xBugzilla x x xBlue Mountain x xCaliber Series (Dhruthi Technologies) xCaliso xCalspex (Vantek Software) xCalTrak (Transcat) xCAMA Software LLC x x x x x x x xCAMO Software AS xCamstar (Siemens) x xCAP Software x xCAQ AG x x x x xCebos x x x x x x xCenturion Quality Management xCERDAC (Simco Electronics) xChartHouse Data Management xCIMx Software xCincom xCintellate (SAI Global) xCIQA x x x x x x x x xCIS Software x x x xCiverex Systems Inc. xClaromentis xClinsys Group x

http://www.auditweaver.com/

http://www.autodeskplm360.com/

http://www.blazesystems.com/

http://www.baytekinternational.com/

http://blue-cat.org/

http://wp.bplm.de/english/#start

http://breeze-software.com/

https://www.bugzilla.org/

https://www.coolblue.com/

http://www.dhruthi.org/QualitySolution.html

http://www.calisouk.com/

http://vantek-nem.com/products/calspex.htm

http://www.transcat.com/calibration-services/quality/calibration-management/

http://camasoftware.com/

http://www.camo.com/

http://camstar.industrysoftware.automation.siemens.com/en/

http://www.capretail.com/

http://www.caq.de/en/

http://www.cebos.com/

http://cqm.co.za/

http://www.simco.com/management_solutions/cerdaac_product_suite/introducing-cerdaac-4/

http://www.charthouseusa.com/products/software

http://www.cimx.com/

http://www.cincom.com/

http://cintellate.saiglobal.com/

http://www.ciqa.net/

http://cissoftware.com/

http://civerex.com/

https://www.claromentis.com/learning-platform/

http://www.clinisysgroup.com/



Document Mgmt EHS




CloudSDS xCloudQMS (Cambio Services LLC) x x x x x x x xCMO Software xCMX (Beamex) xCOMPASS (Process Data Control) xComplaints Pro (Coretec Solutions) xCompli xCompliance 360 (SAI Global) x x xCompliance Control x x x x x x xComplianceQuest x x x x x x xComplianceWire (UL Eduneering) xCompuCal Calibration Solutions xCORE LIMS (Core Informatics) xCornerstone OnDemand xCritical Manufacturing xCSC LIMS xCsols Ltd xCyanic Automation xDataLyzer x xDataPipe (Knorr Associates) xDimensional Control Systems xDexma xDocSpace (Harcourt Consulting Inc) xDocumentum (EMC) x x x x xDocuShare (Xerox) xDokeos xDoneSafe xDRM (Donor Dialog) xe3 Solutions xEasyCal (Time Electronics) x

https://cloudsds.com/about

http://cloudqms.com/

https://cmo-software.com/

http://www.beamex.com/beamex_products/CMX-Enterprise-Calibration-Software/na15ghgl/b0e8f631-0c6b-4387-99fc-4ca6e4b4ea75

http://www.pdccorp.com/fl/index.php

http://www.coretec.com.au/complaintspro

http://www.compli.com/

http://www.compliance360.com/

http://www.compliance-control.com/

http://www.compliancequest.com/

http://www.uleduneering.com/

http://www.compucalcalibrations.com/

http://www.coreinformatics.com/

http://www.cornerstoneondemand.com/

http://criticalmanufacturing.com/en/homepage

http://www.csc.com/health_services/offerings/99982/106597-laboratory_information_management_system_lims

http://www.csols.com/wordpress/

http://www.cyanicautomation.com/about/

http://www.datalyzer.com/

http://knorrassociates.com/

http://www.3dcs.com/

http://dexma-plm.com/en/

http://harcourtconsulting.com/

http://www.emc.com/domains/documentum/index.htm

http://docushare.xerox.com/

http://www.dokeos.com/

http://donesafe.com/

http://www.donordialogue.com/products_drm_touch.html

http://e3solutionsinc.com/home/

http://www.timeelectronics.com/calibration-software/



Document Mgmt EHS




Ecocion xEcoIntense xecoLOGIC Systems x xeCompliance Management Solutions xeDOCS (OpenText) x xEHASoft xEHelioS xEHS Data Limited xEHS Insight (StarTex Software) xEMEX xeMatrix/Matrix One PLM (Dassault Systems) x x x x xEmpower PLM (Omnify Software) x x x x x x xEMSolution (Solution Foundry) xEnablon xEnovia PLM (Dassault Systemes) x x x x xEnsur (Docxellent) x x x x xEntropy (BSI) x x x x x x x x xEnviance xEpicor x x xEPIQ Technologies, Inc. xEpiware (Epiware Document Management Software) x xePowerCenter (Astute Solutions) xERA Environmental Management Solutions xEthics Point (NAVEX Global) xETQ x x x x x x x x x xeTracker xeTraininfo (CIMCON Software) xEusoft Srl xEverest (Lynk Software) xEyelit, Inc xFactory (Aptean) x

http://ecocion.com/main.html

http://www.ecointense.de/

http://www.ecologicsystems.com/

http://www.ecompliance.com/

http://www.opentext.com/

http://www.ehasoft.com/

http://www.ehelios.net/

http://ehsdata.com/

http://www.ehsinsight.com/

http://emex.com/

http://www.3ds.com/products-services/enovia

http://www.omnifysoft.com/

http://www.solutionfoundry.com/offerings/software.aspx

enablon.com/

http://www.3ds.com/products-services/enovia

http://www.docxellent.com/

http://www.bsi-entropy.com/

http://www.enviance.com/index.aspx

http://www.epicor.com/

http://www.epiqtech.com/

http://www.epiware.com/

http://www.astutesolutions.com/

http://www.era-environmental.com/

http://www.navexglobal.com/products/case-management

http://www.etq.com/

http://trackcustomercomplaints.com/

http://www.cimconsolutions.com/eTraininfo-21-CFR-Part-11-Compliance.asp

http://www.eusoft.it/

http://www.lynksoftware.com/

http://www.eyelit.com/

http://www.aptean.com/products/factory-mes



Document Mgmt EHS




Fast Track (Aust) Pty LTD. xField iD (Master Lock) xFileNet (IBM) xFirstDoc (CSC) xFlexMMS (CGA Software) xFlinkISO open source (Techmentis) x x x x x xFormpipe.GxP (Formpipe Software AB) x x x x x xFusion Systems xGageControl (Quality Software Concepts) xGage Insite (Indysoft Corporation) xGageList (Expresso Moon) xGageManager (Altegra) xGAGEpack (PQ Systems) xGAGEtrak/SUPPLIERtrak (CyberMetrics Corporation) x xGMPPro (MOTTO Systems) x x x x x x x x x xGrand Avenue Software x x x x x x xGreenlight.Guru x x x x x x x x xGSQA (EMNS Inc.) x xHalogen Software xHamsagars xHarrington Group International x x x x x xHAZMIN (Logical Technology) xHealthStream xHighJump Software xHoneywell Process Solutions xHP Quality Center x xiBASEt x x x x xIBS US x x x x x x x x xiCOLOGIQ (formerly Quality Online) x x x x x x xIDBS ELN xIdeagen PLC x x x x x

http://www.fasttrack365.com/

http://www.masterlock.com/more-from-master-lock/fieldid

http://www-03.ibm.com/software/products/en/filecontmana/

http://www.csc.com/

https://www.cgatechnology.com/

http://www.flinkiso.com/

http://www.formpipegxp.com/

http://www.fusionsystems.org/

http://www.gagecontrol.com/

http://www.indysoft.com/

http://www.gagelist.com/company.html

http://www.altegra.com/altegra_products1.htm

http://www.pqsystems.com/quality-solutions/gage-management/GAGEpack/

http://www.cybermetrics.com/

http://www.quickgmp.com/

http://www.grandavenue.com/

http://www.greenlight.guru/

http://www.gsqa.com/

http://www.halogensoftware.com/

http://hamsagars.net/hamsfd/hams.htm

http://www.hgint.com/

http://www.comply1.com/

http://www.healthstream.com/

http://www.highjump.com/solutions/manufacturing-execution

https://www.honeywellprocess.com/

http://www8.hp.com/in/en/software-solutions/quality-center-quality-management/

http://www.ibaset.com/

http://www.ibs-us.com/

http://www.icologiq.com/

http://www.idbs.com/en/platform-products/e-workbook/

http://www.ideagenplc.com/



Document Mgmt EHS




IFS xIHS x x xiLearning (Seertech) xImageWave xIN-CAL xIndustrySafe (TRA, Inc.) xInfinity QS xInfor x x x xInfotehna x x x x x x x xIntelex x x x x x x x x xInterax Group x x x x x x x xIntegrum Management Systems x x x x x xIntrastage xIQMS x x x x x x x x x xIQRC, Inc x x x x x x x xIQS, Inc. x x x x x x x x x xi-Sight (Customer Expressions) xIsoma (E Squared UK) xisoTracker (Lenox Hill Ltd.) x x xIsoTrain (Softek) xisoXpress (AQA Company) xISP Software Solutions xIssueTrak xISTM (Remedy) xiTac Software xJDA x xJD Edwards x xJIRA (Atlassian) x x x x x xJobBOSS (Exact Business Software) x xKalypso xKintana (HP/Mercury Interactive) x x

http://www.ifsworld.com/uk/solutions/ifs-applications/

https://www.ihs.com/products/product-change-management.html

http://seertechsolutions.com/ilearning-plus

http://www.imagewave.com/

http://www.in-cal.com/

http://www.industrysafe.com/

http://www.infinityqs.com/

http://www.infor.com/

http://www.infotehna.com/

http://www.intelex.com/

interaxgrp.com/

http://www.integrumsystems.com/

http://www.intrastage.com/

http://www.iqms.com/

http://www.iqrc.com/

http://www.iqs.com/

http://www.customerexpressions.com/cex/cexweb.nsf/HomeDisplay

http://www.isoma.systems/

http://www.lennoxhill.co.uk/

http://www.isotrain.com/

http://www.isoxp.com/00Home/IsoXpHome.aspx

http://www.ispsoftware-solutions.com/

http://www.issuetrak.com/

http://www.bmc.com/it-solutions/remedy-change-management.html

http://en.itac.de/

http://www.jda.com/

http://www.oracle.com/us/products/applications/jd-edwards-enterpriseone/overview/index.html

https://www.atlassian.com/

http://jobboss.exactamerica.com/

http://kalypso.com/services/product-lifecycle-management-plm-technology

http://www8.hp.com/us/en/software-solutions/ppm-it-project-portfolio-management/index.html?jumpid=va_rmvp19jtdi



Document Mgmt EHS




KMI xKnowledge Global xKnowledge Tree xLabsoft (Computing Solutions) xLabtronic / LABWORKS (PerkinElmer) xLabVantage xLabWare (Waters) xLearn.com (Oracle) xLearningPlus xLighthouse Systems Limited xLims1 (Ltech Australia Pty Ltd) xLiquent xLotus Notes x xM3 (Rover Data Systems, LLC) x xMAPEX Software x xMasterControl x x x x x x x xMatrix Gemeni LIMS (Zumatrix/Autoscribe) xMaximo (IBM) xMedgate xMetricStream x x x x x x x xmHelpDesk x xMicrosoft Dynamics xMicrosoft Excel xMicrosoft Navision x xMinitab xMIRS (A V Systems) xMPDV USA xMontrium x x x x x x xMSDSonline xMuddy Boots Software x xNeomatics x x x x x

http://www.kminnovations.com/

http://www.knowledgetree.com/

http://www.labsoftlims.com/

https://www.cambridgesoft.com/Ensemble_for_QA-QC/LimsLink/

http://www.labvantage.com/

http://www.labware.com/

http://www.oracle.com/

http://www.learningplus.com/

http://www.lighthousesystems.com/

http://www.lims1.com/

https://www.parexel.com/solutions/informatics/regulatory-information-management/insight-product-service/

http://www-03.ibm.com/software/products/en/ibmnotes

http://www.roverdata.com/

http://www.emapex.com/

http://www.mastercontrol.com/

http://www.autoscribeinformatics.com/about-us/matrix-gemini

http://www.ibm.com/software/products/en/maximoassetmanagement

http://www.medgate.com/

http://www.metricstream.com/

http://mhelpdesk.com/

http://www.microsoft.com/en-in/dynamics/crm.aspx

https://products.office.com/en-us/excel

https://www.microsoft.com/en-us/dynamics/erp-nav-overview.aspx

http://www.minitab.com/

http://www.mirsinfo.com/

http://www.mpdv-usa.com/

http://www.montrium.com/connect

http://www.msdsonline.com/

http://en.muddyboots.com/quality-control

http://www.neomatics.be/



Document Mgmt EHS




Neosystems xNet-Inspect xNetRegulus (PTC) x xNetSuite xNew Generation Computing, Inc. (NGC) x x xNextDocs x x x x x xNorthwest Analytics (NWA) xNovatek International x x x x x x x x xNoverant xOmnex x x x xOnePlace (Eclipse Computing Australia Pty Ltd) xOnyx (Aptean) xOpen Mind Solutions xOptiva PLM (Infor) x x xOracle x x x x xOracle Harvest xPastel Auditor (Sage) xPDXpert PLM (Active Sensing) x x xPeopleSoft (Oracle) xPerformix, Inc xPharmschul (GMP Software) x xPilgrim Quality Solutions x x x x x x x xPinnacle Business Solutions x xPIVOTAL (Aptean) xPlantNet (Altegra) xPlateau (SAP) xPlex Systems x xPMED (Oazez Software E Tecnologia) xPQ Systems xProactive Health and Safety Solutions xProCAL (Prime Technologies) x

http://www.capterra.com/ehs-management-software/spotlight/136716/iTrak /NeoSystems

https://www.net-inspect.com/

http://www.ptc.com/

http://www.netsuite.com/portal/home.shtml

http://www.ngcsoftware.com/

http://www.nextdocs.com/

http://www.nwasoft.com/

http://www.ntint.com/

http://www.noverant.com/

http://www.omnex.com/

http://www.just1place.com/


http://www.open-mind-solutions.com/

http://www.infor.com/product-summary/plm/optiva/

http://www.oracle.com/

http://www.me.sagepastel.com/Other-Sage-Pastel-Products/Sage-Pastel-Auditor.asp

http://www.buyplm.com/

http://www.oracle.com/us/products/applications/peoplesoft-enterprise/overview/index.html

http://www.performixinc.com/

http://www.gmp-software.eu/

http://www.pilgrimquality.com/

http://www.pinsol.com/


http://www.altegra.com/altegra/plantnetspc.htm

http://www.elearninglearning.com/plateau/sap/

http://www.plex.com/

http://www.oazez.com.br/?page_id=5495

http://www.pqsystems.com/

http://www.phssolutions.ca/

http://www.primetechpa.com/



Document Mgmt EHS




ProcessPro xProdac Systems xProduct Vision (CA Technologies) xProMation Systems Inc. (PSI) xProntoForms xProspecta Software xPSC Software xQ5 Systems x x x xQAD x x x x x xQAI (Quality Institute of America) x x x x x x xQA Systems (QASYS) x x x x x xQMSrs Ltd x x x x x xQPR Software PLC x x xQ-Pulse (Gael) x x x x x x xQT9 (World Quality Systems) x xQTi xQUAD (Aster Technologies) x x x xQualisyst Ltd. xQualitron Systems xQuality Link Software x x x x xQuality Systems Toolbox x x x x x x xQuality-Works (KvalitetsGruppen) x xQualtrax x x x x x x xQuarta (Blulink) x x x xQube Software xQumas (Dassault Systemes) x x x x x x x xRational (IBM) xRedmine x xRegula xRemedy Interactive xRescop x x x x x x x x

http://www.processproerp.com/

http://www.prodacsystems.com/

https://support.ca.com/cadocs/0/CA Agile Vision and CA Product Vision Summer 2012-ENU/Bookshelf.html

http://www.promationsystems.com/

http://www.promationsystems.com/

http://www.prospecta.com/


http://www.q5systems.com/

http://www.qad.com/

http://www.qisssoftware.com/

http://www.qasys.com/solutions.aspx

http://www.qmsrs.com/qmsrsweb

http://www.qpr.com/

http://www.gaelquality.com/

http://www.qtisoft.com/

http://www.qtisoft.com/

http://www.aster-technologies.com/?id=quad

http://www.qsyst.com/qualisyst_en.htm

http://www.qualitronsystems.com/

http://qmsonline.com/

http://www.qualitysystems.com/

http://www.quality-works.com/

http://www.qualtrax.com/

http://www.blulink.com/

http://www.qubesoftware.org/

http://www.qumas.com/

http://www-03.ibm.com/software/products/en/ratichan/

http://www.redmine.org/

http://www.iss-ag.ch/en/regula/regula-the-regulatory-affairs-software-for-medtech

http://www.remedyinteractive.com/

http://www.rescop.com/



Document Mgmt EHS




ReSol Technologies x x x x xRivo Safeguard x x x x xRockwell x xSaba xSaeker Systems xSafety Concepts Group xSafety Tracker Software xSafetyReports.com xSafetySync xSage PLM xSalesforce x xSamanage xSAP x x x x x x x x x x x xSeertech xSelerant x xSercle QMS x x x x x xServiceNOW x x x xSFS Chemical Safety xSharePoint (Microsoft) x x x x x xSiebel (Oracle) xSiemens PLM x xSIMATIC (Siemens) x x xSimpleTrak (ION Quality Systems) x x x x x x x xSimply Safety (CCD Systems) xSinerji (SoftTech A.S.) xSirwill FBM (Global Quality Village) x xSISTRADE Solutions x x xSLIM (InterCAX) x xSmaat (Maerix) xSOAR Solutions x

http://www.resolsystems.com/

http://www.rivosoftware.com/

http://www.rockwellautomation.com/rockwellsoftware/overview.page

http://www.saba.com/us/

http://www.saeker.co.uk/

http://www.safetactics.eu/scg/

http://www.safety-tracker.net/

http://safety-reports.com/

https://www.safetysync.com/

http://www.sage.com/us/erp

http://www.salesforce.com/

https://www.samanage.com/

http://www.sap.com/

https://www.seertechsolutions.com/

http://www.selerant.com/corp/

http://www.sercle.co.uk/

http://www.servicenow.com/

http://chemicalsafety.com/

https://products.office.com/en-us/sharepoint/collaboration

http://www.oracle.com/us/products/applications/siebel/overview/index.html

http://www.plm.automation.siemens.com/en_us/

http://w3.siemens.com/mcms/automation/en/automation-systems/industrial-automation/Pages/Default.aspx

http://www.ionqualitysystems.com/proof/

http://www.simplysafety.com/

http://www.softtech.com.tr/English/urunlerSinerji.asp

https://www.globalqualityvillage.com/

http://www.sistrade.com/en/home.htm

http://intercax.com/

http://www.maerix.com/en/home/

http://www.soarsolutionsinc.com/



Document Mgmt EHS




SoftExpert Software x x x x x x x x xSofTech Inc. x xSoftTech Health LLC x x xSolabs x x x x x x xSopheon x xSpiramid xSQL*LIMS xStar LIMS xSuccessFactors (SAP) xSumTotal xSword Achiever x x x x x x xSymbion Systems, Inc. xSynergy (Zontec) xTaleo (Oracle) xTeamPage (Traction Software) x x xTech-X (Cetex) x x xTEDS Inc. xThe Lean Machine xThermo Scientific (Darwin, Galileo, Nautilus, SampleManager, Watson) xTip Technologies x x x x x x x xTitle21 Health Solutions x x x x x x x x xTMS (Collaborative Quality Systems) xTQS-9000 (ISP Software Solutions) x x xTrackPro xTrackwise (Sparta Systems) x x x x x x xTrakSYS (Parsec Automation) xTRIM Records Management (HP) xUniLab (Siemens) xuniPoint Software x x x x x x x x xuPerform (ANCILE) x

http://www.softexpert.com/

http://www.softech.com/

http://www.softtechhealth.com/Default

http://www.solabs.com/

https://www.sopheon.com/

http://spiramid.com/services/core/

http://www.labvantage.com/

http://www.starlims.com/en-us/home/

http://www.successfactors.com/en_us.html

http://www.sumtotalsystems.com/

http://www.sword-achiever.com/

http://www.gosymbion.com/

http://www.zontec-spc.com/

http://www.oracle.com/us/products/applications/taleo/overview/index.html

http://www.tractionsoftware.com/

http://www.tech-x.com/

http://teds.com/

http://www.theleanmachine.com/

http://www.thermoscientific.com/en/home.html

http://www.tiptech.com/

http://www.title21health.com/

http://collaborativequality.com/

http://www.ispsoftware-solutions.com/TQSSoftware.htm

http://trackpro.org/en/

http://www.spartasystems.com/

http://www.parsec-corp.com/traksys

http://www8.hp.com/us/en/software-solutions/edrms-electronic-document-records-management-system/

http://w5.siemens.com/belux/web/en/industry/industry-solutions/industriele-it/LIMS/Pages/Default.aspx

http://www.unipointsoftware.com/

http://www.ancile.com/



Document Mgmt EHS




Veeva x x x

Verse Solutions x x x x x

Vintara x x x x x x x

Visual Enterprise Solutions x x x

Vivaldi Software x x x x x x

V-Soft Computers x

Wavefront Software x

webOSCAR (Verdi Technology Assoc.) x

Werum Software & Systems x

Windchill Quality Suite (PTC) x x x x x

Windchill PLM (PTC) x x x

WinSPC (DataNet Quality Systems) x

Wonderware (Invensys / Schneider Electric) x x

xTrak (usCalibration) x

ZenDoc (GetZenDoc) x x

ZeraWare x

ZenQMS (formerly The QAB) x x x x x x x

Zumatrix (Autoscribe Informatics) x

https://www.veeva.com/

http://www.versesolutions.com/

http://www.vintara.com/index.html

http://visual-quality.com/default.aspx

http://www.vivaldisoftware.com/

http://v-softcomputers.com/about-us.html

http://www.wavefrontsoftware.com/

http://verditechnology.com/

http://www.werum.com/en/home.html

http://www.ptc.com/about/our-approach/process-expertise/quality-and-reliability-management

http://www.ptc.com/

http://www.winspc.com/products/winspc

http://software.schneider-electric.com/wonderware/

http://www.uscalibration.com/

http://www.getzendoc.com/

http://www.zeraware.com/

http://www.zenqms.com/

http://autoscribeinformatics.com/