1. Gabor Fari Gabor.Fari@microsoft.com April 26, 2007

2. The problem with metadata management Key Metadata-related ECM Issues: Separation of Office Properties and Extended Metadata Management capabilities of legacy ECM Systems No means to synch metadata between heterogeneous Content Management systems (or different versions of legacy systems) Inability to manage the Corporate Truth, i.e. document originality – the average document has 18 identical copies (Cohasset Associates*) How do you manage records retention schedules across multiple repositories? Metadata is one of the biggest critical success factors to sharing information. Metadata can make your information sharing and storage efforts great successes, or great failures. Metadata can get you in trouble with the law, or keep you out of such trouble. The alternative to metadata management is information chaos. “CIO Council - What Every CIO Needs to Know About Metadata” – Feb. 1999

3. The situation today – lack of a common metadata layer across all applications File Server MS CMS ExchangeNotesWebSPSDMSNotes Data- bases SearchSearchSearch MetadataMetadataMetadata SearchSearchSearchSearch Metadata Free/full-text search

4. Intelligent ECM for Life Sciences Part 11 compliant repository PLUS Federated Enterprise Metadata Management and Search Document Lifecycle Management * Rules Based Document Generation and Assembly * Submission Assembly and Publishing * (Plan & Track) * Integrated Submission Management (Plan & Track) * * metadata driven Legacy ECM approaches are ‘repository-centric’ Legacy ECM approaches are ‘repository-centric’ Focus should be instead on metadata and business rules to Focus should be instead on metadata and business rules to manage ‘self-aware’ documents manage ‘self-aware’ documents Metadata Driven Solutions

5. Unified search, categorization and metadata management across ALL content repositories File Server MS CMS ExchangeNotesWebSPSDMSNotes Data- bases Federated metadata layer - unified metadata model and classification across all systems Combined free-text and unified metadata model search across systems Classification within the native application Metadata Index

6. Model Builder – Tagging - Search Model Builder Web Tagging Client Faceted Search Results

7. Tagging Client with auto-suggested metadata terms

8. Metadata Driven Submission Management 8 Submission Planning Content Management eCTD Builder Paper Publishing Legacy DMS DatabaseFile ShareLegacy DMS MS Project MS Word SharePoint User Experience Federated Metadata Model Document Library Business Rules Engine Submission Management

9. Integrated Submission Management (Plan & Track) FDA Planning, assignment, status, routing, approval, organization, and secure repository of critical deliverables for FDA submissions