Solution Presentation

Dr. Reddys Lab May 25th, 2011

CSC Company Overview

Since 1959, Weve Helped Clients Achieve Competitive Advantage from Every Major Technology Wave

We are a world leader in leveraging IT to develop business solutions and services Market-leading corporations and major government agencies partner with us when delivery is critical to their mission Our 91,000 professionals serve clients in more than 90 countries We have a 50-year track record of client service excellence Our global delivery network provides consistent delivery of solutions and services common processes and highly skilled, cost-effective, multilingual resources We are CSC: an NYSE, Fortune 200 and Fortune Most Admired Company 50 Years Strong
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Across the globe

when delivery is critical

CSC Company Overview

CSC ECM Business Strategy

COMBINE
Domain Expertise
CSC industry knowledge and expertise in focused industries Content management/ collaboration

Product Strategy
FirstDoc (Documentum) FirstPoint (SharePoint)

Platform Expertise
Documentum Microsoft

Professional Services
Tightly aligned with product and platform strategy Implementation, upgrades, and system integration with products Integration with products and data stores ECM CMA services Microsoft SharePoint services

TO CREATE CUSTOMER LONGEVIT Y

CSC developed products that continue to enhance and grow to meet customer needs Professional services to drive value of the products into customer specific solutions Continued extensions of product and services capabilities

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Product Overview
Franciska Darmer Solution Specialist

FirstDoc Overview

FirstDoc Enterprise Content Management Solution

Industrys leading Life Sciences content management solution geared towards the authoring, review, approval, storage and retrieval of an organizations mission critical documents FirstDoc Enterprise Platform based on EMC Documentum 21 CFR Part 11 Compliant Out of the box, preconfigured modules for Life Sciences business areas: Research and Development (R&D) Trial Master File (TMF) (next generation FDCT) Quality and Manufacturing (Q&M) Marketing and Sales (M&S) Other areas available via configuration: Medical Information Human Resources Legal

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FirstDoc Architecture Designed to Meet Specific Business Needs

External Stakeholders External User Interface

Regulatory Agencies

Customers

Supply Chain

Business Partners

SharePoint Portal

Internal Stakeholders
R&D TMF Q&M Sales & Marketing Corporate

Internal User Interface

Key Features Compliance Document Template Notification Workflow

FirstDoc WebTop or SharePoint Portal

Document Lifecycle Search Automation Reporting Watermarking Administrative Tools Personalization Business-Specific Configurations PDF Management and Publishing

Business Rules Engine Content Management

EMC Documentum

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FirstDoc Overview

FirstDoc Enterprise + Best Practice Modules

APPLICATION INTEGRATIONS Research & Development eCTD publishing tools FDX Connector Paper publishing tools Registration tracking Quality Manufacturing ERP systems Learning management tools Trial Master Files Clinical trial management systems Imaging tools FD IA connector FD PDF Publisher FD Export Marketing and Sales Siebel sales Seibel marketing Medical Information Siebel call center XML authoring tools Xml publishing tools Corporate ERP systems Accounting Engineering drawing tools

BEST PRACTICE MODULES Research & Development All submission-related document types Non-clinical, clinical, quality, regulatory Document types according to eCTD SPL labeling documents Quality Manufacturing Procedural documents CMC documents Validation documents Batch record documents Package artwork Package specifications Trial Master Files Clinical Clinical site Clinical subject CRFs/DCFs Marketing and Sales Promotional and Collateral materials Medical Information Letters Components Whitepapers and journals Open, body, close, attachments Corporate Legal Contracts Pleading documents Patent documents SEC filings Research documents Engineering Engineering drawings

SHARED FUNCTIONAL CAPABILITIES Functional Capabilities Template-based authoring Auto-filing of documents Copy properties and documents Register interest/ notifications MyViews Data dictionaries Dynamic security Restricted property edit Document autonumbering Document and folder purge User bulk import Auto-populating of properties Product, compound, and study dictionaries Compound alias tracking Local language capable Lifecycle & Workflow Management Dynamic workflow Email notifications Automatic status transition Batch status transition Compliance Document audit trails eSignature and watermarking Document information reporting Audit trail reporting Compound Documents XML document importing Compound document templates and authoring Multi-document routing and review Multi-document status update Innovative Utility and Tools Configuration management utility Batch import User/group administration Configuration objects

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FirstDoc Product Details

Key Items in the FDQM Configuration Set

Properties, Search Screens, Views Lifecycles
Controlled Document Reports Records

Workflows
Review Approval with Electronic Signatures Periodic Review Change Request To Be Read and Understood

Notifications Relationships Watermarks, Headers, Footers Auto-numbering User Groups and Security Document Purging
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FirstDoc 6.2

Document Inventory Analysis

Released Document Specifications & Methods Standard Operating Procedures etc.

Standard Document Validation Documents Project Documents etc.

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THANK YOU