Transforming Regulatory Information Management (RIM)Planet Pharma User Conference, May 2017

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Reduce operational costs

Regulatory Operations Market Drivers

Accelerate time to market

Improve regulatory intelligence

Expand into new markets

x

A single authoritative source for regulated content across domains

Streamlined process for authoring, reviewing and approving submission documentation

Seamless information sharing between sponsors and affiliates

Archiving for a complete view of regulatory activity

Transforming RIM

3

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Built with Documentum D2

Role-based personalized user interface is intuitive and simple to use

Configuration model provides functional agility and responsiveness

Pre-defined industry best practices configurations ensure compliance and speed time to value

Customers are choosing D2-based solutions ….

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DOCUMENTUM D2: Modern UI and Flexible Business Rules

DOCUMENTUM: Proven Compliant and Scalable Platform

eTRIAL MASTER FILE

Trial Master File

Clinical

Property Registration Security ModelsLifecycles and

WorkflowsCompliance Features

RESEARCH and DEVELOPMENT

Quality

Clinical and Safety

Regulatory, Labeling, and Ad/Promo

Nonclinical

QUALITYCLINICAL

UNIFIED SOLUTION LAYER

SUBMISSION STORE and VIEW

Regulatory Correspondence

Regulatory Submissions

QUALITY and MANUFACTURING

Manufacturing

Procedural

Quality

Medical Device DHF DMR

REGULATORY

Change RequestMedical Device Clinical and Regulatory

RPS: Retention Policy Services and Records Management

Document Inventory

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55+ Solution Customers

Strong Adoption of OpenText Solutions

7 of the top 10 pharmaceutical

companies

2 out of the 3 top contract research

organizations

30+ Mid-market solution customers

Pre-configured solutionsEnd to end GxP Cloud ready

Modern UI Platform for partners

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Research and Development

• Manage the creation, review, and approval of regulatory submission documentation

• Leverage pre-defined document taxonomies based on the DIA EDM Reference Model

• Speed deployment with predefined business rules for workflow, lifecycle, and security

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Submission Store and View

• Gain a complete view of regulatory activity

• Import submissions into a compliant, secure repository

• View agency correspondence documents along side submission files for full regulatory activity history

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Hybrid Cloud

Deploy Your Way! Cloud to Fit Every Need

Public CloudPrivate Cloud

• Dedicated or Shared Infrastructure• Private Access• Single Tenant Application

• Solution Specific• Private/Public Access • Single Tenant Application

• Shared Infrastructure• Public Access• Single Tenant Application

Private Cloud Public Cloud

According to a 2014 Gens and Associates Regulatory Information Management survey, the majority with cloud activity prefer a hybrid model (37%), followed by a pure private cloud (24%)

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