str-pres - ebers electronic qms solution powered by opentext - jun 2016


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Stratesys, your Partner of Trust

QA EDMS Solution Demo Session (30 min)

eCTD Solution Demo Session (15 min)

eTMF Solution Demo Session (20 min)

CAPA Solution Demo Session (20 min)



Stratesys, your Partner of Trust


About Stratesys

Global IT Services Provider

4

Stratesys is leader in IT Services and specialist in different technologies with over 18 years of experience in the market. Credited with a high level of specialization, developing business solutions and technological applications for clients.

We can help you define, implement and develop your SAP strategies by utilizing our innovative proven methodologies.

revenue growth in the last 5 years

active clients in all industries

countries with local presence (offices and centers of expertise)

SAP implementation projects

skilled professionals

US$ 42M+ 100%+

200+ 7

800+ 700

Leaders in SAP Technology

Expert Knowledge

Industry Expertise

Software Solutions

IT Strategy

Quality Assurance


About Stratesys Recognized and distinguished within the SAP Ecosystem

Leaders in SAP Technology

5

2nd POSITION

in April 2016 SAP Ranking of SAP Services Partners (Spain)

76 SAP certifications in cross

and industry solutions

40 success stories developed

during the last 5 years

Stratesys is one of the largest SAP specialist firms in the industry. In April 2016 SAP once again recognized our expertise in their annual ranking as one of their service partners leaders in Spain (2nd),

certifying us as experts in 76 solutions (cross and industry) in their portfolio.

http://www.google.es/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=Rx_dplJHWlOTrM&tbnid=mZNM4Sw0SCiwbM:&ved=0CAUQjRw&url=http://www.itelis.eu/podjetje/partnerstvo-z-sap-jem/?lang=en&ei=BzNxUpeDDoba0QW6m4HQCA&bvm=bv.55617003,d.d2k&psig=AFQjCNEVXFfifGPLdV2MUd7Cy-Kv3JRYfg&ust=1383236739695788


About Stratesys

Leaders in OpenText Technology

6

Stratesys is recognized as experts in the delivery of OpenText solutions to its customers. Our deep understanding and wide experience in OpenText products that integrate with our clients SAP and non-SAP software landscape, allows us to deliver Enterprise Information Management value added projects. Our expertise in design-definition, implementation and support, combined with a specific understanding of vertical requirements for vertical markets like Life Science or Construction & Engineering, positions us as one of the major players in project execution in this technology.

Stratesys is committed to maintain up-to-date knowledge through on-going training, certification and blended delivery of services, leveraging our OpenText Center of Excellence, to demonstrate our experience and capabilities of all OpenText solutions.

Our Partnership with Why Stratesys

Stratesys is an OpenText reference technology partner.

We are the first company in Spain to obtain official ranking of SAP Competence Partner.

Stratesys was the inaugural OpenText Partner Spotlight EMEA winner in Spain.

Our OpenText Figures

Skilled Team

70

Projects

150+

Success Stories

15+

Certified in ALL SAP by

OpenText Solutions

10

Active clients

60+

Certified Solutions in

OpenText Catalog

5

We cover the whole OpenText Portfolio

[…]

[Commerce]

[CRM]

[HR] [EAM]

[ERP]

2004

2008

2011

http://www.stratesys-ts.com/wp-content/uploads/2013/09/Stratesys-Flyer-BrandPOS-sept-2013-sin-precio.pdf





About Stratesys

Experts in Life Sciences Industry

7

Stratesys has a deep understanding of the latest tendencies affecting the pharmaceutical industry in general, as well as its relationship with every player in the ecosystem. Our portfolio in this industry includes planning solutions, execution and documentation of every moment in the life cycle of a drug or pharmaceutical product, bearing in mind the distinctive features of product research and development, production, sales and supply, as well as finances and regulations.

Services & Solutions Portfolio

Supply chain planning: demand planning, supply chain planning.

ERP design and implementation on SAP platform.

ECM strategy definition and product selection

Supply chain implementation and integration for third parties: clients, providers, logistics operators, monitoring.

Content and document processing tools. CTD/eCTD, in accordance with 21 CFR part 11.

Workforce mobility

Interfaces with LIMS systems, electronic batch records

Product Safety: Incident Report and CAPA.

Corporate Functions: Debt and Integrated Interests scam Documental Management. Budgeting and Consolidation. Account Analytical Results.

Control Panels and Business Intelligence Dashboards

Implementation of Advanced Management solutions for purchasing and contracting

GxP regulated production. As per GMP and FDA

Talent Management and 360º evaluation

AM and BPO Payroll Services

Our Pharma Industry Figures

Industry Experts

20 Active clients 20+

Projects

75 Official

Success Stories

3

Industry Recognition

Specific Pharma Solutions

Global solution for managing documents and processes of pharmaceutical companies built on Extended ECM by OpenText.

SAP Advanced Track & Trace






About Stratesys

Life Science Customers (ECM)

Our Capabilities

Experts in Pharma Industry

8

Our References – ERP & ECM Customers

Life Science Customers (ERP / BI / HCM)

Life Science Customers (ERP / BI / HCM / ECM)

http://www.google.es/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=lEJd5bCzaeUR8M&tbnid=a_nRrXlTgTBDNM:&ved=0CAUQjRw&url=http://proteccioncivilpedrezuela.com/category/patrocinadores/&ei=dSKCUr-_NuO90QXk6YDQCA&bvm=bv.56146854,d.d2k&psig=AFQjCNEog_oLVJBXD3M5yGWegN0mf6Df1g&ust=1384346611952848

http://www.sanofi.es/l/es/sp/index.jsp

http://www.janssen.es/?product=none


About Stratesys Our clients are leaders in their respective industries

Delivering Solutions Across all Industries

9

Energy & Utilities

Telecom & Media

Manufacturing

Public Sector, Health & Education

Construction & Real Estate

Consumer Goods

Retail

Transportation

Life Sciences

Banking & Insurance


About Stratesys Where our clients need us

Global Presence - Local Support

10

Projects

Offices

Our network of offices and specialized Centers of

Excellence offer coverage to different

geographies and markets where we operate. Our

international presence spans Europe, USA, Latin

America and Asia Pacific.

Madrid Barcelona Valencia Oviedo Seville Coruña

São Paulo Shanghai

Brazil Spain

Palo Alto

USA

China

Armenia Bogotá

Colombia

Lisbon

Portugal

México DF

Mexico

60+ countries

Projects in

We execute multiple implementation and roll-out information systems projects

in more than 60 countries.



QA EDMS Solution Demo Session (30 min)

QA EDMS Solution Overview

QA EDMS Solution Demo

Q&A

QA eDMS



QA eDMS

SOP Management System for OpenText Content Suite

Elements of a pharma QMS

12

CAPA

QA eDMS eCTD CHANGE CONTROL

eTMF








QA eDMS

Business Needs

QA eDMS for OpenText Content Suite

13

In R&D and manufacturing, Standard Operating Procedures (SOPs) define the business rules and processes for everything from pre-clinical research, clinical development, and equipment operation to the release of new products.

Industries regulated by the FDA, such as pharmaceutical, medical device, and biotechnology, SOPs must be strictly managed to assure compliance with current GxP quality guidelines and regulations.

User roles: 5 for SOP, 3 for Fabrication Guides

and 4 for Training

12

Preconfigured Workflows: 5 for SOP, 8 for Training, 2 for Fabrication Guides

15

Prebuilt Document types and subtypes

35

Accelerators for Integrations with SAP HR, SAP PM, SAP BO,

eCTD and Lotus Notes

5

Predefined Business Units and

Departments

20

Preconfigured reports and

custom searches

40



QA eDMS

Business Needs


14

TRAINING SOP MANAGEMENT

FABRICATION GUIDES

Integrated with SAP HR

Employee skill and work role Management

Register of SOP training

Management of External Training

Generation of Skills Certificate

Creation

Revision

Approval

Publishing and Distribution

Review

Archiving

Integrated with SAP manufacturing process

Controlled printing of guides and master document

Change of state workflow

Deviation management



QA eDMS

Master Metadata


15

Center

Document Types (scopes)

Business Units



QA eDMS

Roles per Center:

<center name> - Read

<center name> - Manage

<center name> - Print

<center name> - QA

<center name> - Retire

Roles per Center:

<center name> - Guide Reader

<center name> - Guide Manager

<center name> - Guide Printer

Roles per Center:

<center name> - Read (Employees)

<center name> - Employee Managers

<center name> - HR

<center name> - QA

Classification & Security


16

TRAINING SOP MANAGEMENT FABRICATION GUIDES

Operative Area

Documents

GDF - Document System Management

Documents

Company

Documents

Center

Documents

Department

Documents

_Guides


Company

Center

Year


Company

Center

_Employees


Company

Center

Operative Area

Department

_Job Function


Company

Center

_Courses



QA eDMS

SOP Management


17

Complete traceability of the SOPs lifecycle

Classification Metadata

Reviews and Approvals

Existing controlled copies



QA eDMS

SOP Management


18

Advanced Workflows:

Create SOPs

Review SOPs

Create new versions SOPs

Retire SOPs

eSigning for Tasks



QA eDMS

SOP Management


19

Controlled copies generation in PDF or with watermark with a predetermined printer.

Non controlled copy printing with watermarks



QA eDMS

Fabrication Guides


20

Complete workflow for the fabrication guide:

Integration with fabrication order in SAP

Printing of controlled copies

Fabrication issues registry



QA eDMS

Training


21

Employee Skill Management:

Integrated with employee masterdata

Job description Management

Skill Certificate generation

External and internal Course and training catalog management



QA eDMS

Solution Summary


22

Content Management

Automated version control

Automated notification and distribution

Automated review and approval

Template management

Content comparison

Regulatory Compliance

Complies with GCP DIA Ref Model

Complies with FDA 21CFR Part 11 for electronic document management

Search Functionality

Content and metadata search

User defined saved searches

Security

Role based access to content

Auditability and traceability of the process

Controlled printing

Watermarking for managing hardcopies

Return on Investment

Savings on SOP time generation Productivity Improvement Savings on paper elimination Savings on IT system TCO

Migration tools (i.e.: Lotus Notes)

Training Certificate Report

eCTD integration

Audit Trail Report

Out of Office Report

Integration with Analytics (i.e.: SAP BO)

Value Added Components

Integration with SAP HR


http://www.stratesys-ts.com/wp-content/uploads/2013/01/KAIKU-Implantaci%C3%B3n-SAP-BPC-para-agilizar-la-consolidaci%C3%B3n-ENE13.pdf

http://www.stratesys-ts.com/wp-content/uploads/2012/09/UNIDAD-EDITORIAL-Gesti%C3%B3n-Eventos-Sociales-SAP-CRM-SEP2012.pdf




QA eDMS

Solution Demonstration


23

Document Owner Document Reviewer Document Readers

Document Owner Document Owner

Automatic Notification of Documents to Review

Launch New Version Process

Document is Reviewed with Comments

Comments are Accepted and Document Approved

Automatic Document released to mandatory readers

STEP 1 STEP 3 STEP 5

STEP 2 STEP 4



QA eDMS

Solution Demonstration


24

SOP Information User Activity Dashboard UI




eCTD Solution Demo Session (15 min)

eCTD Solution Overview

eCTD Solution Demo

Q&A

eCTD



eCTD

eCTD for OpenText Content Suite


26

CAPA


eTMF








eCTD

Business Needs

eCTD Solution for OpenText Content Suite

27

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan).

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm330116.htm

http://esubmission.ema.europa.eu/ectd/

http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/index.html

Sources:

User roles

3

Preconfigured workflows

2

Sequence management procedures

2

Accelerators for integration with Submission platforms (Extedo, Lorenz),

Lotus Notes, Sequence Export

3

eCTD prebuilt templates

5

Preconfigured reports

6






http://esubmission.ema.europa.eu/ectd/

http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/index.htm




eCTD

Business Needs


28

The eCTD is the electronic version of the CTD and the preferred format for the submission of files and metadata from a submitter to a receiver. The primary technical components are:

A high level folder structure

An XML "backbone" file which provides metadata about content files and lifecycle instructions for the receiving system

An optional lower level folder structure

Associated document type definitions (DTDs) and stylesheets.

Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. Each sequence has 5 modules:

Module 1: Administrative and prescribing information (may vary in each location)

Module 2: Overview and summary of modules 3 to 5

Module 3: Quality (pharmaceutical documentation)

Module 4: Preclinical (Pharmacology/Toxicology)

Module 5: Clinical – efficacy (Clinical Trials)

Regional Admin

Information

Module1

Quality

Module 3

Nonclinical Study Reports

Module 4

Clinical Study Reports

Module 5

Quality Overall

Summary

Module 2 Nonclinical Overview

Clinical Overview

Nonclinical Summary

Clinical Summary

Not part of the CTD

The CTD

The CTD Triangle



eCTD

Classification & Security


29

Roles per Reference:

Regulatory Affairs => Full permission

Pharmaceutical Development => Write

Clinical Development => Write

QA => Read

System Admin

Reference Template Sequence Template CTD Management



eCTD

CTD Management


30

CTD Generation:

Create Reference

Allocate users for CTD creation

Manage References

Automatic Classification



eCTD

CTD Management


31

Advanced Workflows:

Create New Sequence

Change Sequence Status

Export eCTD

Combine Sequence

eSigning for Tasks



eCTD

Reports


32

Preconfigured usage reports:

References by Country

References by Product

Export to excel



eCTD

eSubmission Integration


33

Content Management:

Study generation

Metadata management

Sequence compilation

Document edition

Study closure

Allocate

Sequence structure export (PDF renditions and XML)

XML

ZIP (folder structure

with PDF documents)

eSubmission Software

Supported eCTD standards:

EU, FDA, CA, CH, JP, MCC, GCC/KSA

Submission Management:

Support for MRP/DCP procedures

Automated eCTD DTD upgrades

Automated management and generation of Study Tagging Files

Support for parallel submissions

Easy reuse of submissions

Integrated Validator

Interim documents for paper publishing

eCTD Generation eCTD Submission



eCTD

eSubmission Integration


34

There is a standard connector between OpenText and Extedo that provides customers the following “out of the box” functionalities:

Connect, add / show document

Check in / Check out

Check for new version

Import/Upload from File System

Search

Import Submission

Upload of submissions to the DMS

Upload of Structured Documents (PIM, SPL, etc.) as ZIP files

Version View (Tab View)

Support for virtual documents

Add custom columns to Add Document dialog

Support of renditions

This connector is implemented in the customers we show this slide and is sold by Extedo, therefore is not included in the bid of materials.


http://www.rovi.es/

http://www.bhfz.com.ua/site/index.php?lang=en



eTMF Solution Demo Session (20 min)

eTMF Solution Overview

eTMF Solution Demo

Q&A

eTMF



eTMF

eTMF for OpenText Content Suite


36

CAPA


eTMF








eTMF

Business Needs


37

Standard Naming

Based on ICH E6 Sect. 8 & industry-accepted terminology

Standard Contents

Industry opinion on what is kept in a TMF

Standard Metadata

For eTMFs, minimum metadata at system and artifact level

Standard Structure

To support paper and electronic systems



eTMF Products

Classification, Security and Masterdata


38

Document Types (Artifacts)

Roles per Company:

<Company>- Viewer

<Company>- CRO

<Company>- TMF Admin

<Company>- System Admin

eTMF Management

Countries & Sites

Products

Countries & Sites

Document Types



eTMF

eTMF Management


39

Standard eTMF Template

TMF Lifecycle Management

Classification Metadata

Document Structure

Default Roles & Permissions (Writer, External, Viewers)

Metadata Navigation



eTMF

eTMF Management


40

Advanced Workflows:

Create eTMF

Document Approval

Close eTMF

eSigning for Tasks TMF Work items



eTMF

eTMF Management


41

Compliance:

Document audit

Document Classification

My Assignments/Tasks



eTMF

Solution Summary


42

Content Management

TMF Taxonomy

Template management

TMF Metadata model

Content reference between TMF

TMF closure workflow

Regulatory Compliance

Complies with GCP DIA Ref Model

Complies with FDA 21CFR Part 11 for electronic document management

Search Functionality

Content and metadata search

User defined saved searches

Metadata Navigation

Security

Role based access to content

eSignature for approvals

Auditability and traceability of the process

Bulk Export

eCTD integration

External Access UI (i.e.: CROs)

Audit Trail Report

Out of Office Report

Integration with Analytics (i.e.: SAP BO)

Value Added Components

Return on Investment

Savings on TMF generation Productivity Improvement Savings on paper elimination Savings on IT system TCO



http://www.stratesys-ts.com/wp-content/uploads/2012/09/UNIDAD-EDITORIAL-Gesti%C3%B3n-Eventos-Sociales-SAP-CRM-SEP2012.pdf





CAPA Solution Demo Session (20 min)

CAPA Solution Overview

CAPA Solution Demo

Q&A

CAPA



CAPA

QA-CAPA Management System for OpenText Content Suite


44

CAPA


eTMF








CAPA

Business Needs

CAPA MS for OpenText Content Suite

45

CAPA is launched by event - either a laboratory investigation, a manufacturing inconsistency, a regulatory or internal audit, or a customer complaint.

Corrective action and preventive action (CAPA) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.

CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

User roles

5

Preconfigured workflows

3 Accelerators for integration with Portals

(SAP or SharePoint), SAP BO and customer communication processes

4

Prebuilt templates (Claims, Non Conformities)

2

preconfigured QA KPIs Dashboard

20



CAPA

Business Needs


46

Absence of predefined rules for workflow

automation

Data quality and volume of information managed

Auditability managed manually

Poor of accessibility

control

Insufficient traceability

Isolated from corporate

infrastructure and data

User reluctancy



CAPA

QA-CAPA Management


47

Corporate Intranet

Request Case

Claim Form

NC Form

QA Team

Approve

Claim List

Non Conformity List



CAPA

QA-CAPA Management


48

QA-CAPA UI Collaborative Tools (Discussion, Task)

Case Participants

QA Team



CAPA

QA-CAPA Management


49

Closed QA-CAPA Closure Workflow QA Users

Mail to Participants



CAPA

QA-CAPA Dashboard


50

CAPA Analytics:

Usage Reports

CAPA Status Reports

Quality KPIs with Business Data



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@stratesys

Copyright Stratesys Technology Solutions. All rights reserved. No part of this document may be reproduced or transmitted by any means,

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