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IT QMS Components
ID: REF-0302871Version: 1Status: EffectiveDate: 2024-10-31Owner: IT Quality Assurance Section LeadScope: Global
QMS Components
Governing Documents
IT Quality Manual (POL-0300118)
Defines Roles (14)
- R044 Global IT Change Management Process Manager
- R045 Global IT Problem Management Process Manager
- R046 Global IT Service and Configuration Management Process ...
- R047 Global Incident Management Process Manager
- R058 IT Continuity Squad Lead
- R066 IT Quality Assurance Section Lead
- R071 Information Security & Privacy Governance
- R074 Integrated Strategy Lead
- R091 Product Line Lead - Developer Platform
- R092 Product Line Lead - Identity & Access Management
- R093 Product Manager - Requirement Risk & Defects Management
- R094 Product Manager - Test Automation & Management
- R111 Section Lead - IT Risk Compliance & Audit
- R113 Security Risk and Audit Product Line Lead
Defines Artifacts (13)
- A011 Architecture Decision Record
- A014 Audit Report
- A034 Change Record
- A041 Configuration Management Database
- A062 Defect Record
- A065 Deviation Record
- A089 Informatics Business Continuity Plan
- A090 Information Security Policy
- A096 Knowledge Article
- A155 System Risk Assessment
- A159 Test Cases
- A163 Test Results
- A176 User/Functional Requirements
References Out (15)
- dir000202
- Good Documentation Practices
- GOV-0100092
- POL-0300107
- IT Quality Manual
- Informatics Computerised Systems Validation Policy
- REF-0301413
- REQ-0300145
- SOP-0301427
- SOP-0301461
- Informatics SOP Training Management
- SOP-0302061
- SOP-0302585
- Computerised Systems Risk Management
- Guideline for use of Agile Frameworks for GxP Systems
Referenced By (1)
Informatics Mandatory Training Catalogue
ID: REF-0303199Version: 3.0Status: EffectiveDate: 23 May 2025Owner: Susanna NagelScope: Global
The purpose of this document is to provide a list of the global mandatory training courses. Please refer to the governing Informatics Training Management SOP for details about scope and roles & responsibilities.
Governing Documents
Training Management SOP (SOP-0301634)
Defines Roles (3)
Defines Artifacts (1)
Implements Citations (2)
References Out (3)
Referenced By (1)