Documentation: Governance
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Roche GxP Data Integrity Policy
ID: GOV-010156Version: 2.0Status: EffectiveDate: 18 Dec 2025Owner: Head of Information Compliance & Records ManagementScope: Global
Information
Defines Roles (4)
Defines Artifacts (1)
Implements Citations (20)
- Access Management
- Archiving
- Audit Trail
- Availability for Inspection
- Backup and Restore
- Collusion Prevention
- Electronic Records (Audit trail in human readable format)
- Electronic Records (Audit trail)
- Electronic Records (Data Integrity)
- Electronic Records (Data Review)
- Electronic Records (Data availbility in human readable forma...
- Electronic Records (Security and Access Management)
- Electronic Signature
- Identity Verification
- Incident Management
- Owner Exclusivity
- Signature Manifestations
- Signature Uniqueness
- Signature/Record Linking
- Uniqueness of ID/Password
References Out (3)
- dir000210
- spt029678
- Roche GxP Data Integrity Standard
Referenced By (9)
- QAG PD/RDT - OUTSOURCED OPERATIONS QUALITY AGREEMENT (Genera...
- Informatics Risk Based Testing Framework
- Informatics Mandatory Training Catalogue
- Group Informatics CSV Lifecycle Operations and Maintenance S...
- Framework for Implementing AI Agents in GxP Applications
- Group Informatics CSV Lifecycle Implementation SOP
- Group Informatics CSV Lifecycle Retirement SOP
- Roche GxP Data Integrity Standard
- Definition of Direct and Indirect Regulatory Impact