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Solution Presentation
Dr. Reddy‘s Lab
May 25th, 2011
04/09/23 CH10_0373 2© 2010 Computer Sciences Corporation
CSC Company Overview
Since 1959, We’ve 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
Across the globe ― when delivery is critical
04/09/23 CH10_0373 3© 2010 Computer Sciences Corporation
CSC ECM Business Strategy
• 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
Domain Expertise
C O M B I N E
T OC R E A T E
C U S T O M E R L O N G E V I T Y
• CSC industry knowledge and expertise in focused industries
• Content management/ collaboration
Platform Expertise• Documentum• Microsoft
Product Strategy• FirstDoc (Documentum)• FirstPoint (SharePoint)
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
CSC Company Overview
Product Overview
Franciska DarmerSolution Specialist
04/09/23 CH10_0373 5© 2010 Computer Sciences Corporation
FirstDoc Enterprise Content Management Solution
• Industry’s leading Life Sciences content management solution geared towards the authoring, review, approval, storage and retrieval of an organization’s 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
FirstDoc Overview
04/09/23 CH10_0373 6© 2010 Computer Sciences Corporation
SharePoint Portal
FirstDoc WebTop or SharePoint Portal
BusinessRules Engine
Key Features
Compliance
Document Template
Notification
Workflow
Document Lifecycle
Search
Automation
Reporting
Watermarking
Administrative Tools
Personalization
Business-Specific Configurations
PDF Management and Publishing
InternalUser Interface
InternalStakeholders
ExternalUser Interface
ExternalStakeholders Regulatory Agencies Customers Supply Chain Business Partners
R&D TMF Q&M Sales & Marketing
Corporate
Content Management
EMC Documentum
FirstDoc Architecture — Designed to Meet Specific Business Needs
04/09/23 CH10_0373 7© 2010 Computer Sciences Corporation
FirstDoc Enterprise + Best Practice Modules
APPLICATION INTEGRATIONS
Research & Development Quality Manufacturing Trial Master Files Marketing and Sales Medical Information Corporate
• eCTD publishing tools• FDX Connector• Paper publishing tools• Registration tracking
• ERP systems• Learning management
tools
• Clinical trial management systems
• Imaging tools• FD IA connector• FD PDF Publisher• FD Export
• Siebel sales• Seibel marketing
• Siebel call center• XML authoring tools• Xml publishing tools
• ERP systems• Accounting• Engineering
drawing tools
BEST PRACTICE MODULES
Research & Development Quality Manufacturing Trial Master Files Marketing and Sales Medical Information Corporate
• All submission-related document types
• Non-clinical, clinical, quality, regulatory
• Document types according to eCTD
• SPL labeling documents
• Procedural documents• CMC documents• Validation documents• Batch record documents• Package artwork• Package specifications
• Clinical• Clinical site• Clinical subject• CRFs/DCFs
• Promotional and Collateral materials
• Letters• Components• Whitepapers and
journals• Open, body, close,
attachments
• Legal– Contracts– Pleading
documents– Patent
documents– SEC filings– Research
documents• Engineering
– Engineering drawings
SHARED FUNCTIONAL CAPABILITIES
Functional Capabilities Lifecycle & Workflow Management
Compliance Compound Documents Innovative Utility and Tools
• Template-based authoring• Auto-filing of documents• Copy properties and
documents• Register interest/
notifications• MyViews• Data dictionaries• Dynamic security• Restricted property edit
• Document auto-numbering
• Document and folder purge
• User bulk import• Auto-populating of
properties• Product, compound, and
study dictionaries• Compound alias tracking• Local language capable
• Dynamic workflow• Email notifications• Automatic status transition• Batch status transition
• Document audit trails
• eSignature and watermarking
• Document information reporting
• Audit trail reporting
• XML document importing
• Compound document templates and authoring
• Multi-document routing and review
• Multi-document status update
• Configuration management utility
• Batch import• User/group
administration• Configuration objects
FirstDoc Overview
04/09/23 CH10_0373 8© 2010 Computer Sciences Corporation
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
FirstDoc Product Details
04/09/23 CH10_0373 9© 2010 Computer Sciences Corporation
Document Inventory Analysis
Released Document•Specifications & Methods•Standard Operating Procedures•etc.
Standard Document•Validation Documents•Project Documents•etc.
FirstDoc 6.2
THANK YOU