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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