Documentation: Policy
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IT Quality Manual
ID: POL-0300118Version: 1.0Status: EffectiveDate: 17 Oct 2024Owner: IT Quality Assurance Section LeadScope: all Roche Informatics
The IT Quality manual defines the elements required for the IT Quality Management System (IT QMS). This IT Quality Manual governs the quality management of IT systems within the responsibility of Roche Informatics and processes owned by or on behalf of Roche Informatics (e.g.
Defines Processes (2)
Defines Roles (4)
Defines Artifacts (5)
References Out (7)
- Good Documentation Practices
- GOV-0100040
- GOV-0100186
- POL-0300038
- pol000011
- IT QMS Components
- Informatics IT Self Inspection Management SOP
Informatics Computerised System Risk Management Policy
ID: POL-0300129Version: 5.0Status: EffectiveDate: 2025-04-28Owner: Process OwnerScope: global
This policy establishes global Risk Management requirements for Roche employees that plan, build, deploy, maintain, use, or retire computerised systems/services processing Roche data.
Governing Documents
none
Defines Roles (3)
Defines Artifacts (2)
Implements Citations (4)
References Out (9)
Referenced By (11)
- OUTSOURCED OPERATIONS QUALITY AGREEMENT (General Requirement...
- QAG PD/RDT - OUTSOURCED OPERATIONS QUALITY AGREEMENT (Genera...
- Informatics Vendor Quality Assessment Questionnaire SPT
- Informatics Risk Based Testing Framework
- Informatics Computerised Systems Validation Policy
- Informatics CSV Periodic Review SOP
- Group Informatics CSV Lifecycle Operations and Maintenance S...
- IT Infrastructure Qualification SOP
- Informatics Vendor Quality Assessment SOP
- Framework for Implementing AI Agents in GxP Applications
- Computerised Systems Risk Management
Informatics Computerised Systems Validation Policy
ID: pol014Version: 8.0Status: EffectiveDate: 28 Apr 2025Owner: Process OwnerScope: global
This policy establishes a single, global quality governance framework for the validation of computerised systems (CS), including AI Sub-systems as part of an overarching computerized system.
Governing Documents
none
Defines Roles (3)
Implements Citations (77)
- Ability to Generate Copies
- Access Management
- Applicability to ER/ES
- Archiving
- Audit Trail
- Authority Checks
- Availability for Inspection
- Backup and Restore
- Business Continuity
- CS Inventory
- Change Management
- Collusion Prevention
- Credential Maintenance
- Definition: Act (FD&C Act)
- Definition: Agency (FDA)
- Definition: Biometrics
- Definition: Closed System
- Definition: Digital Signature
- Definition: Electronic Record
- Definition: Electronic Signature
- Definition: Handwritten Signature
- Definition: Open System
- Device (Terminal) Checks
- Device Testing
- Dual-Component Requirement: Single Session and New Session P...
- Education & Training
- Electronic Records (Audit trail in human readable format)
- Electronic Records (Audit trail)
- Electronic Records (Data Integrity)
- Electronic Records (Data availbility in human readable forma...
- Electronic Records (Security and Access Management)
- Electronic Signature
- Electronic in lieu of Paper
- Electronic records/signatures in lieu of paper (Maintained r...
- Identity Verification
- Incident Management
- Individual Accountability
- Infrastructure Qualification
- Legal Binding Certification
- Limiting System Access
- Loss Management
- Non-Repudiation Letter
- Ongoing Validation
- Open System Controls
- Operational Checks
- Owner Exclusivity
- Periodic Review
- Protection/Retention
- Qualified Test Environment
- Quality Management System (in house)
- Quality Management System (supplier)
- Risk Management
- Security Controls
- Security Monitoring
- Signature Equivalence
- Signature Manifestations
- Signature Uniqueness
- Signature/Record Linking
- Submissions to the Agency (Specific formats/media)
- System Authorization
- System Description
- System Documentation Ctrl
- System Performance
- Test Evidences
- Testing Tools Validation
- Time-stamped Audit Trails
- Traceability
- Training of Personnel
- Trustworthiness & Reliability
- Uniqueness of ID/Password
- User requirement specifications
- Validation
- Validation Approach
- Validation Documentation (Change control and Deviations)
- Validation Documentation (Planning and Reporting)
- Validation of Systems
- Vendor Documentation
References Out (13)
- dir000202
- FOR-0306446
- Handling Computerised System Glossary
- GOV-0100092
- IT Quality Manual
- Informatics Computerised System Risk Management Policy
- Informatics CSV Periodic Review SOP
- Group Informatics CSV Lifecycle Operations and Maintenance S...
- Group Informatics AI Computerised Sub-system Validation Life...
- IT Infrastructure Qualification SOP
- Group Informatics CSV Lifecycle Implementation SOP
- Computerised Systems Risk Management
- Group Informatics CSV Lifecycle Retirement SOP
Referenced By (20)
- OUTSOURCED OPERATIONS QUALITY AGREEMENT (General Requirement...
- QAG PD/RDT - OUTSOURCED OPERATIONS QUALITY AGREEMENT (Genera...
- Informatics Vendor Quality Assessment Questionnaire SPT
- Informatics Risk Based Testing Framework
- Informatics Computerised System Risk Management Policy
- IT QMS Components
- Informatics CSV Periodic Review SOP
- Group Informatics CSV Lifecycle Operations and Maintenance S...
- Global Incident Management SOP
- Group Informatics AI Computerised Sub-system Validation Life...
- IT Infrastructure Qualification SOP
- Informatics Vendor Quality Assessment SOP
- Group Informatics Generative AI Computerised Sub-system Vali...
- RDT Change Management SOP
- Framework for Implementing AI Agents in GxP Applications
- Group Informatics CSV Lifecycle Implementation SOP
- Computerised Systems Risk Management
- Group Informatics CSV Lifecycle Retirement SOP
- Roche GxP Data Integrity Standard
- Definition of Direct and Indirect Regulatory Impact