enabling digital transformation in life sciences industry

Digital Transformation forHealthcare & Life Science

www.newgensoft.com

Agenda

CEO Top Priority

Source: PWC 2015

Growing Challenges

• Highly Document Intensive

• Ever Changing Regulatory Compliances

• Visibility across all Processes

• Scaling process and operations

• Monitoring Productivity, SLA, TATs

• Change & Transition management

Newgen Overview

1200+ Customers

1 of 3 vendors to feature

in MQs for

iBPMS, ECM & CCM

58Countries

200+ Partners

1600+Employees

100+ Healthcare Customers globally

40+Patents

World’s largest ECM Project in Insurance Sector with

9 Billion docs

ECM MQ

“Visionary Quadrant”

Investors

Offices

Singapore

USA • Florida• Washington DC

Canada

UK

UAE

India• New Delhi• Mumbai• Chennai

Industry Recognized Product Portfolio

Gartner MQ for Enterprise Content Management

Gartner MQ for Intelligent Business Process Management Suites

Gartner MQ for Customer Communication Management

Gartner MQ for Case Management Report

Global Presence: Marquee Customers

BFSI

Finance

BPO & Shared Services

Health Care &

Life Sciences

Newgen Product Portfolio

Product Logical Architecture

Straight Through

Process

Heads Down Production

Process

Collaborative Human

Process

Semi Structured

Process

Fully Unstructured

Process

1 2 3

Gateways

• Web Services

• JMS

• Web APIs

• UI Integration

• Advanced

Terminal Emulator

Integration

Adaptors

iBPMS Components

Process Initiation

Fax Event Scan

MobileEmail Portal

Process Execution

Engine

Business Activity

Monitoring

Social Media

Integration

Process

Modeler

Content

Management

Process

Simulator

Mobile

Integration

Adaptor

Business Rules

Management

System

CEP Analytics

Newgen Solution

iBPM ECM

Process Accelerators

Content Capture

Appeals & Grievances

Quality & Manufacturing Process

Employee On-Boarding

Art Work Management

Provider Contracting

Patient Record Mgmt

Infrastructure

Database ServersConnectivity

Procure To Pay Record To Report F&A Processes

Legacy Applications

Pharma: Solution Accelerators

Goods Manufacturing Process

Document Lifecycle Management

• Standard Operating Procedure (SOP)

• Master Formula Record (MFR)

• Master Packaging Record (MPR)

• Batch Manufacturing Record (BMR)

• Batch Packaging Record (BPR)

Batch Production Process

Artwork Management Process

Promotional Material Process

Close Loop Marketing

Healthcare Payer: Solution Accelerators

Member Enrollment

Provider Contracting

Appeals & Grievances

Claims Management

Solution Accelerators for Hospitals

Document Lifecycle Management

• Legal Contracting and Maintenance

• F&A Documents Management

• Electronics Customer Health Records

• Central SOP Repository

• Records Management

• Document Acquisition Management

• Patient Record Management

Electronic Medical Record

Complaints Management

Consent Management

Customer Communication Management

Finance and Accounts

• Transactional• Accounts Payable (AP) or Procure-To-

Pay (PTP)

• Accounts Receivable (AR) or Sales-Order-To-Cash (SOTC)

• PO Approval

• Order to Cash

• Collections

• General Ledger (GL) or Records-To-Reports (RTR)

• Fixed Assets Management (FA) or CAPEX Management

• Tender Processing / Quotation Management

• Freight Bill Processing – Inward & Outward

• Master Data Management• Vendor Master

• Price Master

• Item Master

• Vendor/Consultant Agreements

• Lease & Agreements

• Query Resolution• Vendor Query Management

Human Resources

• Employee Reimbursements• Travel & Expense

• Medical Claims

• PL Encashment

• Advance Request

• Payroll Additions/ Deductions

• Leave Management

• Contract Management

• Hire-to-Retire• Indent

• On boarding

• Ongoing Appraisals

• Exit Formalities

Admin

• Service Request Process

• Travel desk Management

• Suggestion Scheme Process

SSC: Process Accelerators

Quality & Manufacturing Solution for Pharmaceuticals

Cost of GMP* Non-Compliance

Leading Pharmaceutical Drug

Manufacturer found non -

compliant to GMP standards

by FDA

73 out of 125 drugs put on

Consent Decree list by FDA

Production suspended for

drugs on list

Nearly $250 million lost in

profits for a single drug on the

decree list in 1 year

$500 million paid out in fines

* GMP refers to Good Manufacturing Practices

Source:

1. BioPharm International, “After the Consent Decree – An Uphill Battle for Affected

Companies”, 1 Jun 2004, http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=102280

2. © 2011, Daratech, Inc, Cambridge, MA, USA Reference. 8.178 (charts-ecmppv-pie-1.gif)

$1,000,000Production Interruptions

Cost per day due to halted production

Consent Decree Fines for failing to comply with GMP or other

federal requirements

$50-500 mn

$5 to $975K

Legal Finesfor violations of environmental

regulations by manufacturing facilities

GMP Compliance - Challenges and Risks

Difficulty in managing myriad types, multiple versions

and large volumes of pharmaceutical documents

Inaccurate documentation produced during Regulatory

Audits for GMP Compliance

Regulatory Warnings & Denial of Drug Entry into Market

Drug Revenue Loss

Newgen Quality & Manufacturing Solution for Pharmaceuticals

• Complete Document Lifecycle Management

• Out of Box compliance with FDA 21 CFR part 11 regulations

• Increased productivity and quicker employee TBR training on

SOP documents

Document Lifecycle

Management

• Ensured right document delivery at various production steps

• Controlled access to all documents from single repository Strong Checkpoints for Batch

Production

• Fast access to documents and document audit details

required during GMP compliance auditsCompliance Desktop

Newgen Solution Features

Newgen Solution Feature Set

Content Creation

Dictionaries and Taxonomies

Document Templates

Auto-Naming/Linking

Content Lifecycle Management

Workflow

Task Notification

Change Control

Version Management

Content Transformation

PDF Rendering

Overlay

Watermark

Controlled Printing

PDF Annotation

Content Compliance

Electronic Signature

Audit Trail

Search

Reporting Dashboards

Support for 21 CFR Part 11

Document Lifecycle Management

Document Authoring

Document

Review

Document

Approval

Quality Check

Effective and Revised Versions

Controlled

Document

Usage

Automated workflow for online

document review-approval

Flexible workflow definition

System managed document

states Draft, In Review, At Approval, QA

Pending Release, Effective,

Superseded

Automatic PDF rendering &

watermarking of document

Automatic document version

management

Controlled document access &

printing

Configurable document

related states, types and

metadata

HOD Initiates Document Creation

HOD

• Initiates document creation

• Captures document details (metadata)

• Select workflow for review –approval of draft document

Author Checks Out Document Template

Author

• Checks out document template for creating draft

• Checks –in, e-signs and submits draft document for review

21 CFR Part 11 Compliant

Solution satisfies CFR 21 part 11

requirements for e-signatures

Documents e-signed using

unique combination of username

and password at each stage of

document creation/revision

lifecycle

Signatures appended to

document contain:

Name of signer

Data and time of executing

signature

Reason for executing signature

21 CFR Part 11 Compliant

Signatures appended to

document contain

Name of signer

Reason for executing

signature

Data and time of

executing signature

Reviewer –Approver Annotates Document Rendition

Reviewer/Approver

• Review draft document rendition

• Specify review comments using annotations

• Send document back to author/ send forward for Approval & QA check

Two Document View

• Reviewer can view previously annotated document and newly corrected document sent

by author side by side

Quality Assurance User Sets Effective Date

Quality Assurance User

• Perform final check of document rendition

• Specify review comments using annotations

• Send document back to approver/ set effective date for document

View List of Recently Effective Documents

Strong Checkpoints for Batch Production

Process Order received

Automatic

check for

availability of

correct batch

production

documents

Production documents attached for

batch production

Documents watermarked

and batch number

recorded on Documents

Document Issued to

Production for printing and

usage

Documents Scanned and archived in

system after production completion

Ensure right document delivery at drug production checkpoints

System Controlled Document Delivery for Batch Production

Batch number attached to document issued to production user

Compliance Desktop for Document Access

• Instant online document access using Full Text Search and Advanced meta data search

• Controlled access and printing of documents

• Quick access to document audit details for compliance audits

Access Document Audit Trails

System maintained audit trails

about all document related user

actions including:

Authoring

Check-out/Check-in

Rejection

Review, Approval

Revision

Download/Printing

Single point access to all

document versions

Case Study - Strides

Challenges

• Standardization of location specific requirements

• Need of better visibility and control over their manufacturing practices

• Integration with Legacy documents archived through Parallel Scanning Exercise

• Flow of hard copies of controlled documents used to increase operational costs

Benefits

• Increased visibility of the issuance process for manufacturing

• Controlled flow of documents online

• Timely automated system alerts/escalations

• Watermarking

• Automated checking of Manufacturing License before issuance to production

Profile

• World’s largest Soft gelatin capsule manufacturer

• Leading manufacturer of niche pharmaceutical and nutritional products

Processes Automated

• Product Permission (Drug License) Process

• Master Formula Record (MFR)

• Master Packaging Record (MPR)

• Batch Manufacturing Record (BMR)

• Batch Packaging Record (BPR)

• Issuance and Execution of Process Orders from SAP

Our Approach

• Platform - not a Point Solution

• Scale Processes Locations Users

• Out of box Template process (L1 , L2 & L3)

• Pro-agile Implementation methodology (prototypes)

• Map customer requirement using graphical Process Modeler

• Configurable real time monitoring platform

Envisaged ROI from Digitization

Digitization

Productivity Optimization

Overheads

Compliance

Mandatory Norms Adhered to

First Time Right

Fraud Control

Standardization

User Utilization

User Productivity

TAT Reduction

SLA Management

Reduce Exceptions

Technology & Maintenance

Disputes

Courier Cost

Handle 33% More Volume with same users

Reduce up to 55% costs on overheads

Reduce up to

100%

Thank you