Compliance Map

Overview Authority Documents
Citations
Search All All Groups CIS Controls ® V8 (171)CIS Controls® V7.1 (191)CISA Security Requirements for Restricted Transactions (26)CSA Cloud Controls Matrix (CCM), V4 (197)EU GMP Annex 11 (40)FDA 21 CFR Part 11 (44)HIPAA Security Rule (64)ICFR (51)ISO IEC 27001 (93)NIST CSF v2.0 (134)NIST PF 1.0 (121)
Policies
Control Objectives
Search All All Categories Uncategorized (276)Mapping (20)Acquisition or sale of facilities, technology, and services (19)Application Security (1)Applications (67)Applications/Network (3)Audits and risk management (125)Data (50)Deprecated (2)Devices (55)Encryption (2)Governance, Risk and Compliance (17)Host and Endpoint Security (1)Human Resources management (56)Identity and Access (13)Leadership and high level objectives (50)Logging, Monitoring, Threat Detection, and Analytics (6)Monitoring and measurement (116)Network (84)Network and Infrastructure (3)Operational management (172)Periodic Review (17)Physical Security (10)Physical and environmental protection (80)Privacy protection for information and data (43)Records management (61)Roche Security Standards (4)Root (1)SAP Application Security (12)System hardening through configuration management (131)Systems continuity (74)Systems design, build, and implementation (95)Technical security (197)Third Party and supply chain oversight (46)Users (62)Vulnerability and Configuration Analysis (11)
Processes
Search All All Domains System Lifecycle Management (18)Risk Management (2)AI/ML Lifecycle Management (16)Change & Configuration Management (10)Incident & Problem Management (5)Deviation & CAPA (3)Quality Management System (8)Vendor & Third-Party Management (1)Documentation & Records (2)Information Security (4)
Roles
Search All All Domains Cross-domain (44)System Lifecycle Management (15)Risk Management (1)AI/ML Lifecycle Management (5)Change & Configuration Management (11)Incident & Problem Management (13)Deviation & CAPA (3)Quality Management System (23)Vendor & Third-Party Management (2)Documentation & Records (9)Information Security (6)
Artifacts
Search All All Domains System Lifecycle Management (74)Risk Management (7)AI/ML Lifecycle Management (18)Change & Configuration Management (19)Incident & Problem Management (8)Deviation & CAPA (6)Quality Management System (21)Vendor & Third-Party Management (2)Documentation & Records (21)Information Security (5)
Documentation
Search All All Types Agreement (2)Governance (1)Guideline (5)Other (2)Policy (3)Reference (2)Requirement (1)SOP (19)Supporting Document (4)Work Instruction (3)

Documentation: Agreement

No documents match the current filters.
OUTSOURCED OPERATIONS QUALITY AGREEMENT (General Requirements Informatics)
ID: AGR-0304935Version: 4.0Status: EffectiveDate: 2025-09-29
This document shall serve as a Quality Agreement between the following parties with the goal to ensure quality and compliance with all health authority regulatory and company requirements related to the GxP computerised systems in use by PT, which they collectively support: - Roche Integrated Inform
Defines Processes (2)
Defines Roles (6)Show all 6...
Defines Artifacts (5)
Implements Citations (1)
References Out (31)Show all 31...
QAG PD/RDT - OUTSOURCED OPERATIONS QUALITY AGREEMENT (General Requirements Informatics)
ID: AGR-0305900Version: 2.0Status: EffectiveDate: 07 Jul 2026
This document shall serve as a Quality Assurance Agreement with the goal to ensure quality and compliance with all health authority, regulatory, and company requirements related to the GxP computerised systems used by PD, which they collectively support: - Roche Digital Technology (RDT) - HEREINAFTE
Defines Processes (2)
Defines Roles (6)Show all 6...
Defines Artifacts (10)Show all 10...
Implements Citations (1)
References Out (19)Show all 19...
Graph Explorer