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EU GMP Annex 11: Computerised Systems

Self-Assess
European Union (EMA/EC)
v2022
20 domains
48 controls

EU GMP Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in the pharmaceutical industry, including manufacturing, testing, and distribution. Published by the European Commission as part of EudraLex Volume 4, it covers the entire lifecycle of computerised systems, data integrity, risk management, and compliance requirements for regulated operations.

Verified

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (20)

Audit Trail

1 controls
Controls in the Audit Trail domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-10Audit Trails

Change

1 controls
Controls in the Change domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-17Change and Configuration Management

Compliance

1 controls
Controls in the Compliance domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-25Inspection Readiness

Data Integrity

4 controls
Controls in the Data Integrity domain of EU GMP Annex 11: Computerised Systems — 4 controls
CodeTitle
GMP11-07Data Integrity ALCOA Plus
GMP11-08Data Input Accuracy Checks
GMP11-09Accuracy and Range Checks at Interfaces
GMP11-22Time Stamp and System Clock

E-Signatures

1 controls
Controls in the E-Signatures domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-11Electronic Signatures

General Requirements

9 controls

Six general requirements that apply across all four pillars

Controls in the General Requirements domain of EU GMP Annex 11: Computerised Systems — 9 controls
CodeTitle
Clause 1Risk management
Clause 2Personnel
Clause 3Suppliers and service providers
TNFD-GR-1Materiality
TNFD-GR-2Scope of Disclosures
TNFD-GR-3Location of Nature-related Issues
TNFD-GR-4Integration with Other Sustainability Disclosures
TNFD-GR-5Time Horizons
TNFD-GR-6Engagement with Affected Stakeholders

Governance

1 controls
Controls in the Governance domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-02Personnel and Responsibilities

Lifecycle

2 controls
Controls in the Lifecycle domain of EU GMP Annex 11: Computerised Systems — 2 controls
CodeTitle
GMP11-18Periodic Evaluation
GMP11-24Decommissioning and Data Migration

Operational Phase — Change and Configuration

2 controls
Controls in the Operational Phase — Change and Configuration domain of EU GMP Annex 11: Computerised Systems — 2 controls
CodeTitle
Clause 10Change and configuration management
Clause 11Periodic evaluation

Operational Phase — Data Management

5 controls
Controls in the Operational Phase — Data Management domain of EU GMP Annex 11: Computerised Systems — 5 controls
CodeTitle
Clause 5Data
Clause 6Accuracy checks
Clause 7Data storage
Clause 8Printouts
Clause 9Audit trails

Operational Phase — Release and Continuity

3 controls
Controls in the Operational Phase — Release and Continuity domain of EU GMP Annex 11: Computerised Systems — 3 controls
CodeTitle
Clause 15Batch release
Clause 16Business continuity
Clause 17Archiving

Operational Phase — Security and Access

3 controls
Controls in the Operational Phase — Security and Access domain of EU GMP Annex 11: Computerised Systems — 3 controls
CodeTitle
Clause 12Security
Clause 13Incident management
Clause 14Electronic signatures

Operations

2 controls
Controls in the Operations domain of EU GMP Annex 11: Computerised Systems — 2 controls
CodeTitle
GMP11-19Incident Management
GMP11-20Batch Release Using Electronic Records

Project Phase

1 controls
Controls in the Project Phase domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
Clause 4Validation

Records

2 controls
Controls in the Records domain of EU GMP Annex 11: Computerised Systems — 2 controls
CodeTitle
GMP11-16Archiving
GMP11-21Printouts and Verification

Resilience

2 controls
Controls in the Resilience domain of EU GMP Annex 11: Computerised Systems — 2 controls
CodeTitle
GMP11-14Backups
GMP11-15Business Continuity

Risk

1 controls
Controls in the Risk domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-01Risk Management Approach

Security

3 controls
Controls in the Security domain of EU GMP Annex 11: Computerised Systems — 3 controls
CodeTitle
GMP11-12Access Control and Identity Management
GMP11-13Periodic Access Review
GMP11-23Security and Cybersecurity Safeguards

Supplier

1 controls
Controls in the Supplier domain of EU GMP Annex 11: Computerised Systems — 1 controls
CodeTitle
GMP11-03Suppliers and Service Providers

Validation

3 controls
Controls in the Validation domain of EU GMP Annex 11: Computerised Systems — 3 controls
CodeTitle
GMP11-04Validation Lifecycle
GMP11-05User Requirements Specification (URS)
GMP11-06Configuration Management

Your Compliance Coverage

If you comply with EU GMP Annex 11: Computerised Systems, you already cover:

AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)

17%

8 controls mapped

Compare →

CFTC System Safeguards (17 CFR 37, 38, 39, 49)

17%

8 controls mapped

Compare →

ASIC Cyber Resilience Good Practices

17%

8 controls mapped

Compare →

+ 648 more: CSA STAR (Security, Trust, Assurance, and Risk) (17%), FTC GLBA Safeguards Rule (16 CFR Part 314) (17%)

See all 651 mapped frameworks ↓

Maps to 651 other frameworks

48 total controls
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
8 source controls mapped|10 target controls covered
17%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
8 source controls mapped|14 target controls covered
17%
ASIC Cyber Resilience Good Practices
8 source controls mapped|9 target controls covered
17%
CSA STAR (Security, Trust, Assurance, and Risk)
8 source controls mapped|7 target controls covered
17%
FTC GLBA Safeguards Rule (16 CFR Part 314)
8 source controls mapped|12 target controls covered
17%
South Korea ISMS-P
8 source controls mapped|9 target controls covered
17%
ASD Information Security Manual (ISM)
8 source controls mapped|20 target controls covered
17%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
8 source controls mapped|11 target controls covered
17%
Canada ITSG-33 — IT Security Risk Management
8 source controls mapped|11 target controls covered
17%
New Zealand Information Security Manual (NZISM)
8 source controls mapped|11 target controls covered
17%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|11 target controls covered
17%
South Korea Cloud Security Assurance Program (CSAP)
8 source controls mapped|12 target controls covered
17%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
8 source controls mapped|13 target controls covered
17%
Defence Security Principles Framework (DSPF)
8 source controls mapped|23 target controls covered
17%
Protective Security Policy Framework (PSPF) Release 2024
8 source controls mapped|24 target controls covered
17%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
7 source controls mapped|12 target controls covered
15%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
7 source controls mapped|8 target controls covered
15%
CSA CCM v4
7 source controls mapped|22 target controls covered
15%
ISO 28001:2007 Supply Chain Security Management
7 source controls mapped|9 target controls covered
15%
EIOPA Guidelines on ICT Security and Governance (2023)
7 source controls mapped|14 target controls covered
15%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
7 source controls mapped|10 target controls covered
15%
NIS2 Directive Implementing Acts
7 source controls mapped|17 target controls covered
15%
FAA Cybersecurity Framework for Aviation
7 source controls mapped|18 target controls covered
15%
RBI Cybersecurity Framework for Banks
7 source controls mapped|10 target controls covered
15%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
7 source controls mapped|13 target controls covered
15%
FedRAMP Rev 5
7 source controls mapped|21 target controls covered
15%
OWASP Top 10:2025
7 source controls mapped|7 target controls covered
15%
TISAX — Trusted Information Security Assessment Exchange
7 source controls mapped|14 target controls covered
15%
Telecommunications Sector Security Reforms (TSSR)
7 source controls mapped|10 target controls covered
15%
NIST SP 800-82 Rev 3 — Guide to OT Security
7 source controls mapped|11 target controls covered
15%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
6 source controls mapped|9 target controls covered
13%
BCBS 239
6 source controls mapped|12 target controls covered
13%
APRA CPS 234
6 source controls mapped|10 target controls covered
13%
ASIS SPC.1-2009 — Organizational Resilience Standard
6 source controls mapped|4 target controls covered
13%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)
6 source controls mapped|12 target controls covered
13%
PCI SSF
6 source controls mapped|10 target controls covered
13%
FTC Safeguards Rule (16 CFR Part 314)
6 source controls mapped|12 target controls covered
13%
TIBER-EU (Threat Intelligence-Based Ethical Red Teaming - European Union)
6 source controls mapped|10 target controls covered
13%
SWIFT CSCF
6 source controls mapped|12 target controls covered
13%
MAS TRM
6 source controls mapped|10 target controls covered
13%
HKMA SPM
6 source controls mapped|10 target controls covered
13%
AICPA SOC 1
6 source controls mapped|10 target controls covered
13%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
6 source controls mapped|10 target controls covered
13%
PCI P2PE
6 source controls mapped|10 target controls covered
13%
DORA
6 source controls mapped|15 target controls covered
13%
FFIEC IT Examination Handbook
6 source controls mapped|10 target controls covered
13%
PCI PIN Security
6 source controls mapped|10 target controls covered
13%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
6 source controls mapped|9 target controls covered
13%
Japan FSA Cybersecurity Guidelines for Financial Institutions
6 source controls mapped|10 target controls covered
13%
Kuwait National Cybersecurity Framework
6 source controls mapped|9 target controls covered
13%
SWIFT CSP
6 source controls mapped|10 target controls covered
13%
GLBA
6 source controls mapped|10 target controls covered
13%
OSFI B-13
6 source controls mapped|10 target controls covered
13%
Open Banking Security
6 source controls mapped|10 target controls covered
13%
AICPA SOC 3
6 source controls mapped|10 target controls covered
13%
PSD2 SCA
6 source controls mapped|10 target controls covered
13%
ISO 27001:2022
6 source controls mapped|12 target controls covered
13%
NIS2 Directive (Directive (EU) 2022/2555)
6 source controls mapped|10 target controls covered
13%
UK Telecommunications (Security) Act 2021
6 source controls mapped|16 target controls covered
13%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
6 source controls mapped|10 target controls covered
13%
CIS Controls v8
6 source controls mapped|11 target controls covered
13%
C2M2
6 source controls mapped|13 target controls covered
13%
HKMA Cyber Resilience Assessment Framework (C-RAF)
6 source controls mapped|9 target controls covered
13%
Australian Energy Sector Cyber Security Framework (AESCSF)
6 source controls mapped|17 target controls covered
13%
Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data
6 source controls mapped|8 target controls covered
13%
NAIC Insurance Data Security Model Law (MDL-668)
6 source controls mapped|11 target controls covered
13%
OWASP DevSecOps Maturity Model (DSOMM)
6 source controls mapped|9 target controls covered
13%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
6 source controls mapped|4 target controls covered
13%
GLI-33 — Gaming Laboratories International Event Wagering Systems
6 source controls mapped|10 target controls covered
13%
PCI DSS v4.0
6 source controls mapped|12 target controls covered
13%
NIS2 Directive
6 source controls mapped|17 target controls covered
13%
EU Maritime Single Window Environment Regulation (EU) 2019/1239
6 source controls mapped|9 target controls covered
13%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
6 source controls mapped|7 target controls covered
13%
NIST SP 800-53 Rev 5
6 source controls mapped|19 target controls covered
13%
LGPD
6 source controls mapped|6 target controls covered
13%
SWIFT Customer Security Programme (CSP)
6 source controls mapped|6 target controls covered
13%
South Korea PIPA
6 source controls mapped|5 target controls covered
13%
Bermuda Personal Information Protection Act 2016 (PIPA)
6 source controls mapped|6 target controls covered
13%
US ITAR and EAR — Export Control and Data Security
6 source controls mapped|8 target controls covered
13%
UK Gambling Commission — Cyber Resilience Requirements
6 source controls mapped|9 target controls covered
13%
ISO 13485
6 source controls mapped|6 target controls covered
13%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
6 source controls mapped|8 target controls covered
13%
O-RAN Alliance Security Specifications (O-RAN.WG11)
6 source controls mapped|6 target controls covered
13%
NIST AI Risk Management Framework (AI RMF 1.0)
6 source controls mapped|11 target controls covered
13%
NIST AI 600-1 Generative AI Profile
6 source controls mapped|12 target controls covered
13%
CAIQ (CSA)
6 source controls mapped|7 target controls covered
13%
AWS Well-Architected Security Pillar
6 source controls mapped|7 target controls covered
13%
Azure Security Benchmark
6 source controls mapped|8 target controls covered
13%
C5 (Germany)
6 source controls mapped|7 target controls covered
13%
ISO 27018
6 source controls mapped|7 target controls covered
13%
NIST SP 800-190
6 source controls mapped|7 target controls covered
13%
NIST SP 800-145
6 source controls mapped|7 target controls covered
13%
ISMAP (Japan)
6 source controls mapped|7 target controls covered
13%
MTCS (Singapore)
6 source controls mapped|7 target controls covered
13%
BREEAM — Building Research Establishment Environmental Assessment Method
6 source controls mapped|7 target controls covered
13%
AICPA Privacy Management Framework (PMF)
6 source controls mapped|5 target controls covered
13%
NIST SP 800-146
6 source controls mapped|7 target controls covered
13%
NIST SP 800-144
6 source controls mapped|7 target controls covered
13%
ISO 27017
6 source controls mapped|7 target controls covered
13%
ISO/IEC 27031:2011
5 source controls mapped|4 target controls covered
10%
BS 65000:2014 — Guidance on Organizational Resilience
5 source controls mapped|5 target controls covered
10%
EU NIS2 Directive — Transport Sector Requirements
5 source controls mapped|5 target controls covered
10%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
5 source controls mapped|12 target controls covered
10%
Oman National Cybersecurity Framework
5 source controls mapped|8 target controls covered
10%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
5 source controls mapped|8 target controls covered
10%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|10 target controls covered
10%
ISO 41001:2018 — Facility Management Systems
5 source controls mapped|9 target controls covered
10%
ISO 39001:2012 — Road Traffic Safety Management
5 source controls mapped|9 target controls covered
10%
ISO 50001:2018 — Energy Management Systems
5 source controls mapped|9 target controls covered
10%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
5 source controls mapped|9 target controls covered
10%
Australian Information Security Manual
5 source controls mapped|5 target controls covered
10%
CISA Zero Trust Maturity Model
5 source controls mapped|16 target controls covered
10%
Cyber Essentials Plus
5 source controls mapped|16 target controls covered
10%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
5 source controls mapped|14 target controls covered
10%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
5 source controls mapped|6 target controls covered
10%
BSIMM
5 source controls mapped|5 target controls covered
10%
BSI IT-Grundschutz
5 source controls mapped|15 target controls covered
10%
IEC 62351 — Power Systems Communication Security
5 source controls mapped|3 target controls covered
10%
California IoT Security Law
5 source controls mapped|5 target controls covered
10%
API 1164
5 source controls mapped|11 target controls covered
10%
OWASP ASVS
5 source controls mapped|5 target controls covered
10%
Belgium CyberFundamentals
5 source controls mapped|16 target controls covered
10%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|7 target controls covered
10%
3GPP Security
5 source controls mapped|5 target controls covered
10%
ISO/IEC 27011:2024
5 source controls mapped|7 target controls covered
10%
ANSSI Cybersecurity Framework
5 source controls mapped|16 target controls covered
10%
BIMCO Cyber Security
5 source controls mapped|11 target controls covered
10%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
5 source controls mapped|11 target controls covered
10%
HL7 FHIR Security Framework
5 source controls mapped|7 target controls covered
10%
NIST SP 800-88
5 source controls mapped|5 target controls covered
10%
NIST SP 800-61
5 source controls mapped|5 target controls covered
10%
NIST SP 800-171
5 source controls mapped|18 target controls covered
10%
NIST SP 800-53A
5 source controls mapped|15 target controls covered
10%
DO-326A / ED-202A
5 source controls mapped|11 target controls covered
10%
Proposal for a Regulation on Cyber Resilience Act (CRA)
5 source controls mapped|5 target controls covered
10%
IEEE 1686
5 source controls mapped|11 target controls covered
10%
NIST SP 800-187
5 source controls mapped|5 target controls covered
10%
UNECE WP.29 R155
5 source controls mapped|5 target controls covered
10%
NIST SP 1800-32
5 source controls mapped|11 target controls covered
10%
Ghana Cybersecurity Act
5 source controls mapped|15 target controls covered
10%
NIST SP 800-160
5 source controls mapped|5 target controls covered
10%
NIST SP 800-181
5 source controls mapped|5 target controls covered
10%
NIST SP 800-207
5 source controls mapped|5 target controls covered
10%
OWASP SAMM
5 source controls mapped|5 target controls covered
10%
ISO 27043
5 source controls mapped|5 target controls covered
10%
NIST SP 800-172
5 source controls mapped|15 target controls covered
10%
Spain ENS
5 source controls mapped|16 target controls covered
10%
ISO/SAE 21434
5 source controls mapped|5 target controls covered
10%
OWASP MASVS
5 source controls mapped|5 target controls covered
10%
ISO 27019
5 source controls mapped|11 target controls covered
10%
NIST SP 800-218
5 source controls mapped|5 target controls covered
10%
NIST SP 800-150
5 source controls mapped|5 target controls covered
10%
SSDF (NIST)
5 source controls mapped|5 target controls covered
10%
FBI CJIS Security Policy
5 source controls mapped|8 target controls covered
10%
PTES
5 source controls mapped|5 target controls covered
10%
SIG (Shared Assessments)
5 source controls mapped|5 target controls covered
10%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
5 source controls mapped|3 target controls covered
10%
NIST SP 800-128
5 source controls mapped|5 target controls covered
10%
NIST SP 800-183
5 source controls mapped|5 target controls covered
10%
UNECE WP.29 R156
5 source controls mapped|5 target controls covered
10%
MITRE D3FEND
5 source controls mapped|5 target controls covered
10%
NIST SP 800-63
5 source controls mapped|5 target controls covered
10%
SLSA
5 source controls mapped|5 target controls covered
10%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
5 source controls mapped|6 target controls covered
10%
ETSI EN 303 645
5 source controls mapped|5 target controls covered
10%
NIST SP 800-92
5 source controls mapped|5 target controls covered
10%
SOC 2
5 source controls mapped|5 target controls covered
10%
NIST SP 800-137
5 source controls mapped|5 target controls covered
10%
UK PSTI Act
5 source controls mapped|5 target controls covered
10%
DoD Zero Trust Reference Architecture
5 source controls mapped|16 target controls covered
10%
ISO 27002:2022
5 source controls mapped|6 target controls covered
10%
NIST Privacy Framework 1.0
5 source controls mapped|10 target controls covered
10%
NIST SP 800-123
5 source controls mapped|5 target controls covered
10%
MITRE ATT&CK
5 source controls mapped|5 target controls covered
10%
IEC 62443
5 source controls mapped|11 target controls covered
10%
NIST SP 800-161
5 source controls mapped|5 target controls covered
10%
TSA Pipeline Security
5 source controls mapped|12 target controls covered
10%
OpenSSF Scorecard
5 source controls mapped|5 target controls covered
10%
ISO 20000-1
5 source controls mapped|6 target controls covered
10%
FISMA
5 source controls mapped|16 target controls covered
10%
IRS Publication 1075 — Tax Information Security Guidelines
5 source controls mapped|3 target controls covered
10%
NIST SP 800-115
5 source controls mapped|5 target controls covered
10%
Saudi NCA ECC
5 source controls mapped|15 target controls covered
10%
TEFCA — Trusted Exchange Framework and Common Agreement
5 source controls mapped|3 target controls covered
10%
Singapore Cybersecurity Act 2018
5 source controls mapped|3 target controls covered
10%
Laos Law on Prevention and Combating Cybercrime (2015)
5 source controls mapped|9 target controls covered
10%
UAE Federal Data Protection Law
5 source controls mapped|4 target controls covered
10%
GDPR
5 source controls mapped|4 target controls covered
10%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
5 source controls mapped|7 target controls covered
10%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
5 source controls mapped|6 target controls covered
10%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
5 source controls mapped|6 target controls covered
10%
Australia Consumer Data Right — Banking (CDR)
5 source controls mapped|8 target controls covered
10%
Barbados Data Protection Act 2019
5 source controls mapped|2 target controls covered
10%
ISO/IEC 29147:2018
5 source controls mapped|4 target controls covered
10%
PCI DSS 4.0
5 source controls mapped|3 target controls covered
10%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
5 source controls mapped|8 target controls covered
10%
Chile Personal Data Protection Law (Law No. 21.719)
5 source controls mapped|5 target controls covered
10%
SSAE 18 — Attestation Standards (SOC Reporting)
5 source controls mapped|9 target controls covered
10%
MTCS — Multi-Tier Cloud Security (Singapore)
5 source controls mapped|3 target controls covered
10%
ISO 22320:2018
5 source controls mapped|7 target controls covered
10%
Notifiable Data Breaches Scheme (Australia)
5 source controls mapped|8 target controls covered
10%
EU Digital Markets Act
5 source controls mapped|7 target controls covered
10%
FTC Health Breach Notification Rule
5 source controls mapped|9 target controls covered
10%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
5 source controls mapped|7 target controls covered
10%
EAR — Export Administration Regulations
5 source controls mapped|7 target controls covered
10%
European Accessibility Act (Directive (EU) 2019/882)
5 source controls mapped|7 target controls covered
10%
Regulation (EU) 2023/1115 on deforestation-free supply chains
5 source controls mapped|7 target controls covered
10%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
5 source controls mapped|8 target controls covered
10%
US SEC Digital Assets and Crypto Regulatory Framework
5 source controls mapped|9 target controls covered
10%
Australia eSafety Commissioner — Online Safety Expectations for Industry
5 source controls mapped|7 target controls covered
10%
Trinidad and Tobago Data Protection Act 2011
5 source controls mapped|5 target controls covered
10%
NIST Cybersecurity Framework 2.0
5 source controls mapped|13 target controls covered
10%
UK GDPR (UK General Data Protection Regulation)
5 source controls mapped|3 target controls covered
10%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
5 source controls mapped|3 target controls covered
10%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
5 source controls mapped|3 target controls covered
10%
SANS Incident Handler's Handbook and PICERL Methodology
5 source controls mapped|5 target controls covered
10%
Czech Republic Act on the Protection of Personal Data (Act No. 110/2019 Coll.)
5 source controls mapped|6 target controls covered
10%
Botswana Data Protection Act (2024)
5 source controls mapped|7 target controls covered
10%
ASEAN Data Management Framework
5 source controls mapped|9 target controls covered
10%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
5 source controls mapped|5 target controls covered
10%
French Sapin II Law (Law No. 2016-1691)
5 source controls mapped|4 target controls covered
10%
EU Taxonomy Regulation (Regulation 2020/852)
5 source controls mapped|9 target controls covered
10%
ISO/IEC 38500:2024 — Governance of IT
5 source controls mapped|5 target controls covered
10%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|5 target controls covered
10%
EU Taxonomy Regulation
5 source controls mapped|7 target controls covered
10%
ISO 37000:2021 — Governance of Organizations
5 source controls mapped|6 target controls covered
10%
ISO 20400:2017 — Sustainable Procurement
5 source controls mapped|6 target controls covered
10%
APRA CPS 230 Operational Risk Management
4 source controls mapped|9 target controls covered
8%
ISO/IEC 27010:2015
4 source controls mapped|5 target controls covered
8%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|5 target controls covered
8%
ISO 56002
4 source controls mapped|7 target controls covered
8%
ISO 37002:2021 — Whistleblowing Management Systems
4 source controls mapped|6 target controls covered
8%
Customs-Trade Partnership Against Terrorism (C-TPAT)
4 source controls mapped|9 target controls covered
8%
Critical Raw Materials Act (Proposed Regulation COM(2023) 192)
4 source controls mapped|9 target controls covered
8%
EDM Council CDMC — Cloud Data Management Capability Framework
4 source controls mapped|4 target controls covered
8%
NIST SP 800-171A — Assessing CUI Security Requirements
4 source controls mapped|10 target controls covered
8%
C-TPAT — Customs-Trade Partnership Against Terrorism
4 source controls mapped|8 target controls covered
8%
ICAO Annex 17 — Aviation Security (AVSEC)
4 source controls mapped|4 target controls covered
8%
HIPAA Security Rule
4 source controls mapped|8 target controls covered
8%
Australia My Health Records Act 2012
4 source controls mapped|5 target controls covered
8%
DISA Security Technical Implementation Guides (STIGs)
4 source controls mapped|10 target controls covered
8%
TSA Pipeline Cybersecurity Directives
4 source controls mapped|4 target controls covered
8%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
4 source controls mapped|6 target controls covered
8%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|2 target controls covered
8%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|5 target controls covered
8%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
4 source controls mapped|5 target controls covered
8%
EU Data Act
4 source controls mapped|2 target controls covered
8%
ISO/IEC 27400:2022
4 source controls mapped|5 target controls covered
8%
APRA Prudential Standard CPS 234 — Information Security (Australia)
4 source controls mapped|4 target controls covered
8%
China Cybersecurity Law (CSL)
4 source controls mapped|4 target controls covered
8%
Cyber Security Act 2024 (Australia)
4 source controls mapped|4 target controls covered
8%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
4 source controls mapped|4 target controls covered
8%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
4 source controls mapped|4 target controls covered
8%
Serbia Law on Personal Data Protection (2018)
4 source controls mapped|6 target controls covered
8%
ISO/IEC 30111:2019
4 source controls mapped|4 target controls covered
8%
Pakistan Personal Data Protection Bill 2023
4 source controls mapped|5 target controls covered
8%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
4 source controls mapped|4 target controls covered
8%
UK Open Banking Standard
4 source controls mapped|2 target controls covered
8%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
4 source controls mapped|5 target controls covered
8%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
4 source controls mapped|5 target controls covered
8%
Nigeria Data Protection Act 2023 (NDPA)
4 source controls mapped|3 target controls covered
8%
NERC CIP
4 source controls mapped|8 target controls covered
8%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
4 source controls mapped|4 target controls covered
8%
Philippines Cybercrime Prevention Act (RA 10175)
4 source controls mapped|3 target controls covered
8%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
4 source controls mapped|6 target controls covered
8%
Tanzania Personal Data Protection Act (Draft)
4 source controls mapped|4 target controls covered
8%
Cayman Islands Data Protection Act 2017 (DPA)
4 source controls mapped|4 target controls covered
8%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
4 source controls mapped|7 target controls covered
8%
Brunei Personal Data Protection Order 2024 (PDPO)
4 source controls mapped|6 target controls covered
8%
Zimbabwe Data Protection Act (2021)
4 source controls mapped|5 target controls covered
8%
Digital Economy Partnership Agreement (DEPA)
4 source controls mapped|4 target controls covered
8%
NIST SP 800-124 Rev 2 — Mobile Device Security
4 source controls mapped|4 target controls covered
8%
Ghana Data Protection Act 2012 (Act 843)
4 source controls mapped|3 target controls covered
8%
South Korea Personal Information Protection Act (PIPA)
4 source controls mapped|8 target controls covered
8%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
4 source controls mapped|7 target controls covered
8%
Montenegro Law on Personal Data Protection (2023)
4 source controls mapped|7 target controls covered
8%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
4 source controls mapped|8 target controls covered
8%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
4 source controls mapped|6 target controls covered
8%
EU Product Liability Directive (Directive (EU) 2023/2845)
4 source controls mapped|7 target controls covered
8%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
4 source controls mapped|7 target controls covered
8%
EU Pay Transparency Directive (Directive (EU) 2023/970)
4 source controls mapped|7 target controls covered
8%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
4 source controls mapped|7 target controls covered
8%
EU AI Act
4 source controls mapped|8 target controls covered
8%
China Personal Information Protection Law (PIPL)
4 source controls mapped|4 target controls covered
8%
EU Seveso III Directive (Directive 2012/18/EU)
4 source controls mapped|6 target controls covered
8%
EU European Media Freedom Act (EMFA)
4 source controls mapped|6 target controls covered
8%
Digital Services Act (DSA) - Regulation (EU) 2022/2065
4 source controls mapped|5 target controls covered
8%
6th Anti-Money Laundering Directive (AMLD6, Directive (EU) 2018/1673)
4 source controls mapped|7 target controls covered
8%
EU Carbon Border Adjustment Mechanism (CBAM)
4 source controls mapped|5 target controls covered
8%
EU Energy Performance of Buildings Directive (EPBD Recast) – Draft Directive (2023/0317 COD)
4 source controls mapped|4 target controls covered
8%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|5 target controls covered
8%
EU ePrivacy Directive (2002/58/EC)
4 source controls mapped|5 target controls covered
8%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
4 source controls mapped|4 target controls covered
8%
African Union Malabo Convention
4 source controls mapped|5 target controls covered
8%
Georgia Law on Personal Data Protection (2012)
4 source controls mapped|6 target controls covered
8%
Costa Rica Personal Data Protection Law (Law No. 8968) as amended by Executive Decree No. 42089-MGP
4 source controls mapped|6 target controls covered
8%
Peru Personal Data Protection Law (Law No. 29733)
4 source controls mapped|4 target controls covered
8%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
4 source controls mapped|4 target controls covered
8%
Côte d'Ivoire Law No. 2013-450 on the Protection of Personal Data
4 source controls mapped|5 target controls covered
8%
Uzbekistan Law on Personal Data (No. ZRU-547)
4 source controls mapped|5 target controls covered
8%
Colombia Data Protection Law (Law 1581 of 2012)
4 source controls mapped|6 target controls covered
8%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
4 source controls mapped|5 target controls covered
8%
Lithuania Law on Legal Protection of Personal Data (2018)
4 source controls mapped|4 target controls covered
8%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
4 source controls mapped|7 target controls covered
8%
Malta Data Protection Act (Cap. 586, 2018)
4 source controls mapped|7 target controls covered
8%
Oman Personal Data Protection Law (Royal Decree 6/2022)
4 source controls mapped|6 target controls covered
8%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
4 source controls mapped|5 target controls covered
8%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
4 source controls mapped|5 target controls covered
8%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
4 source controls mapped|6 target controls covered
8%
SQF Code Edition 9 — Safe Quality Food
4 source controls mapped|3 target controls covered
8%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
4 source controls mapped|9 target controls covered
8%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
8%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
4 source controls mapped|5 target controls covered
8%
Connecticut Data Privacy Act (CTDPA)
4 source controls mapped|5 target controls covered
8%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
8%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|6 target controls covered
8%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|4 target controls covered
8%
ISO/IEC 29134:2023
4 source controls mapped|5 target controls covered
8%
ISO/IEC 27014:2020
4 source controls mapped|4 target controls covered
8%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
4 source controls mapped|4 target controls covered
8%
EU Markets in Crypto-Assets Regulation (MiCA)
4 source controls mapped|7 target controls covered
8%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
4 source controls mapped|4 target controls covered
8%
EU Digital Services Act (Regulation (EU) 2022/2065)
4 source controls mapped|3 target controls covered
8%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
4 source controls mapped|3 target controls covered
8%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
4 source controls mapped|6 target controls covered
8%
AS9100D — Aerospace Quality Management System
4 source controls mapped|8 target controls covered
8%
ISO/IEC 27003:2017
4 source controls mapped|8 target controls covered
8%
TNFD Recommendations
4 source controls mapped|7 target controls covered
8%
AASB S2 Climate-related Disclosures
4 source controls mapped|10 target controls covered
8%
Saudi PDPL
4 source controls mapped|2 target controls covered
8%
FedRAMP High
4 source controls mapped|3 target controls covered
8%
NIST SP 800-53 Rev 5 HIGH
4 source controls mapped|3 target controls covered
8%
IRS Publication 1075
4 source controls mapped|3 target controls covered
8%
FedRAMP Moderate
4 source controls mapped|3 target controls covered
8%
NIST SP 800-53 Rev 5 MODERATE
4 source controls mapped|3 target controls covered
8%
NIST SP 800-53 Rev 5 LOW
4 source controls mapped|3 target controls covered
8%
3GPP Security Architecture (TS 33.501 — 5G Security)
4 source controls mapped|9 target controls covered
8%
ISO 14001
4 source controls mapped|4 target controls covered
8%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|8 target controls covered
8%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|4 target controls covered
8%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|10 target controls covered
8%
ICH Q10 — Pharmaceutical Quality System
4 source controls mapped|6 target controls covered
8%
US OFAC Sanctions Compliance Framework
4 source controls mapped|4 target controls covered
8%
EN 50126, EN 50128, and EN 50129 — Railway Applications - Reliability, Availability, Maintainability and Safety (RAMS)
4 source controls mapped|5 target controls covered
8%
EU Payment Services Directive (PSD2) – Under Review
4 source controls mapped|4 target controls covered
8%
ISO 26262:2018 — Functional Safety for Road Vehicles
4 source controls mapped|4 target controls covered
8%
EDM Council DCAM — Data Management Capability Assessment Model
4 source controls mapped|5 target controls covered
8%
ISO 8000 — Data Quality
4 source controls mapped|5 target controls covered
8%
COSO Enterprise Risk Management (ERM) Framework (2017)
4 source controls mapped|5 target controls covered
8%
SASB Standards (ISSB Integrated)
4 source controls mapped|7 target controls covered
8%
SASB Standards
4 source controls mapped|6 target controls covered
8%
ISO/IEC 25012:2008 — Data Quality Model
4 source controls mapped|3 target controls covered
8%
ISO/IEC 23894:2023
4 source controls mapped|10 target controls covered
8%
IATF 16949:2016 — Quality Management System for Automotive Production
4 source controls mapped|5 target controls covered
8%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|4 target controls covered
8%
ECB TIBER-EU Framework
4 source controls mapped|3 target controls covered
8%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|5 target controls covered
8%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
8%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|3 target controls covered
8%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
4 source controls mapped|5 target controls covered
8%
ASD Strategies to Mitigate Cyber Security Incidents
3 source controls mapped|6 target controls covered
6%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|7 target controls covered
6%
Lloyd's Minimum Standards — Cyber Security
3 source controls mapped|7 target controls covered
6%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
3 source controls mapped|5 target controls covered
6%
Colorado Privacy Act
3 source controls mapped|4 target controls covered
6%
Bahrain PDPL
3 source controls mapped|4 target controls covered
6%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|14 target controls covered
6%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|8 target controls covered
6%
EU Chips Act (Regulation (EU) 2023/1781) — potential incorrect regulation number
3 source controls mapped|8 target controls covered
6%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
3 source controls mapped|3 target controls covered
6%
CCPA/CPRA
3 source controls mapped|4 target controls covered
6%
COPPA
3 source controls mapped|4 target controls covered
6%
Chile DPL
3 source controls mapped|4 target controls covered
6%
CTDPA (Connecticut Data Privacy Act)
3 source controls mapped|4 target controls covered
6%
Switzerland FADP
3 source controls mapped|4 target controls covered
6%
Argentina PDPA
3 source controls mapped|4 target controls covered
6%
APPI
3 source controls mapped|4 target controls covered
6%
Privacy Act 1988 (Australia)
3 source controls mapped|4 target controls covered
6%
Philippines DPA
3 source controls mapped|4 target controls covered
6%
Vietnam PDPD
3 source controls mapped|4 target controls covered
6%
Indonesia PDP Law
3 source controls mapped|4 target controls covered
6%
PIPEDA
3 source controls mapped|4 target controls covered
6%
Oregon Consumer Privacy Act
3 source controls mapped|4 target controls covered
6%
FDA 21 CFR Part 11
3 source controls mapped|5 target controls covered
6%
HITECH Act
3 source controls mapped|2 target controls covered
6%
Qatar DPL
3 source controls mapped|4 target controls covered
6%
Uruguay DPL
3 source controls mapped|4 target controls covered
6%
Malaysia PDPA 2010
3 source controls mapped|4 target controls covered
6%
Utah Consumer Privacy Act
3 source controls mapped|4 target controls covered
6%
Minnesota Consumer Data Privacy Act
3 source controls mapped|4 target controls covered
6%
New Hampshire Privacy Act
3 source controls mapped|4 target controls covered
6%
Sigstore — Software Artifact Signing and Verification
3 source controls mapped|5 target controls covered
6%
Tennessee IPA
3 source controls mapped|4 target controls covered
6%
Ley Orgánica de Protección de Datos Personales (LOPDP)
3 source controls mapped|4 target controls covered
6%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
3 source controls mapped|5 target controls covered
6%
ISO 27799
3 source controls mapped|5 target controls covered
6%
ISO 27701
3 source controls mapped|4 target controls covered
6%
Iowa Consumer Data Protection Act
3 source controls mapped|4 target controls covered
6%
Rwanda DPL
3 source controls mapped|4 target controls covered
6%
Peru DPL
3 source controls mapped|4 target controls covered
6%
Iceland DPA
3 source controls mapped|4 target controls covered
6%
NIST SP 800-66
3 source controls mapped|5 target controls covered
6%
Maryland Online Data Privacy Act
3 source controls mapped|4 target controls covered
6%
ITIL 4
3 source controls mapped|4 target controls covered
6%
India DPDP Act
3 source controls mapped|4 target controls covered
6%
UK Data Protection Act 2018
3 source controls mapped|4 target controls covered
6%
Kentucky Consumer Data Protection Act
3 source controls mapped|4 target controls covered
6%
Taiwan PDPA
3 source controls mapped|4 target controls covered
6%
Mauritius DPA
3 source controls mapped|4 target controls covered
6%
New Jersey Data Privacy Act
3 source controls mapped|4 target controls covered
6%
NIST SP 800-122
3 source controls mapped|4 target controls covered
6%
Saudi Arabia PDPL
3 source controls mapped|4 target controls covered
6%
PDPA Singapore
3 source controls mapped|4 target controls covered
6%
Norway PDPA
3 source controls mapped|4 target controls covered
6%
Mexico LFPDPPP
3 source controls mapped|4 target controls covered
6%
Jamaica DPA
3 source controls mapped|4 target controls covered
6%
Montana Consumer Data Privacy Act
3 source controls mapped|4 target controls covered
6%
Indiana Consumer Data Protection Act
3 source controls mapped|4 target controls covered
6%
Turkey KVKK
3 source controls mapped|4 target controls covered
6%
Defence Industry Security Program (DISP)
3 source controls mapped|4 target controls covered
6%
MDS2 (Medical Device)
3 source controls mapped|5 target controls covered
6%
Delaware Online Privacy and Protection Act (proposed)
3 source controls mapped|4 target controls covered
6%
MARS-E
3 source controls mapped|5 target controls covered
6%
PDPA Thailand
3 source controls mapped|4 target controls covered
6%
Law No. 172-13 on the Protection of Personal Data
3 source controls mapped|4 target controls covered
6%
Virginia CDPA
3 source controls mapped|4 target controls covered
6%
Texas Data Privacy Act
3 source controls mapped|4 target controls covered
6%
Liechtenstein DPA
3 source controls mapped|4 target controls covered
6%
Nebraska Data Privacy Act
3 source controls mapped|4 target controls covered
6%
China PIPL
3 source controls mapped|4 target controls covered
6%
Kenya DPA
3 source controls mapped|4 target controls covered
6%
Kenya Data Protection Act
3 source controls mapped|4 target controls covered
6%
FERPA
3 source controls mapped|4 target controls covered
6%
Nigeria NDPR
3 source controls mapped|4 target controls covered
6%
POPIA
3 source controls mapped|4 target controls covered
6%
UAE PDPL
3 source controls mapped|4 target controls covered
6%
New Zealand Privacy Act
3 source controls mapped|4 target controls covered
6%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|8 target controls covered
6%
US Executive Order 14028 — Improving the Nation's Cybersecurity
3 source controls mapped|4 target controls covered
6%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
3 source controls mapped|4 target controls covered
6%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|4 target controls covered
6%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|4 target controls covered
6%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|5 target controls covered
6%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|7 target controls covered
6%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
6%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|5 target controls covered
6%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|5 target controls covered
6%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
3 source controls mapped|6 target controls covered
6%
Morocco Data Protection Law (09-08)
3 source controls mapped|5 target controls covered
6%
Cook Islands Electronic Transactions Act 2003
3 source controls mapped|4 target controls covered
6%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
3 source controls mapped|3 target controls covered
6%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|4 target controls covered
6%
EU AI Liability Directive
3 source controls mapped|4 target controls covered
6%
EU Audiovisual Media Services Directive (AVMSD, Directive 2010/13/EU as amended by Directive 2018/1808 and Directive (EU) 2023/2586)
3 source controls mapped|2 target controls covered
6%
EU Web Accessibility Directive (Directive 2016/2102)
3 source controls mapped|3 target controls covered
6%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|3 target controls covered
6%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
6%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|3 target controls covered
6%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
3 source controls mapped|2 target controls covered
6%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|3 target controls covered
6%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
6%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|4 target controls covered
6%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|5 target controls covered
6%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
3 source controls mapped|6 target controls covered
6%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
3 source controls mapped|5 target controls covered
6%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|5 target controls covered
6%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|4 target controls covered
6%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
3 source controls mapped|3 target controls covered
6%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
3 source controls mapped|2 target controls covered
6%
Fiji Data Protection Bill (2020)
3 source controls mapped|5 target controls covered
6%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|4 target controls covered
6%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|1 target controls covered
6%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|3 target controls covered
6%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|3 target controls covered
6%
Angola Personal Data Protection Law (Law No. 22/11)
3 source controls mapped|4 target controls covered
6%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
6%
21 CFR Part 58 — Good Laboratory Practice (GLP)
3 source controls mapped|2 target controls covered
6%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|4 target controls covered
6%
SWIFT CSCF v2024
3 source controls mapped|3 target controls covered
6%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|5 target controls covered
6%
Armenia Law on Protection of Personal Data (2015)
3 source controls mapped|3 target controls covered
6%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
3 source controls mapped|3 target controls covered
6%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
6%
21 CFR Part 211 — Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
6%
MiFID II / MiFIR
3 source controls mapped|2 target controls covered
6%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|2 target controls covered
6%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
6%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|2 target controls covered
6%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
6%
South Korea Credit Information Act
3 source controls mapped|1 target controls covered
6%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
6%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
6%
3GPP 5G Security Architecture (TS 33.501)
3 source controls mapped|2 target controls covered
6%
ISO 19011
3 source controls mapped|4 target controls covered
6%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|1 target controls covered
6%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
6%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
6%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
6%
ISO 13485:2016
3 source controls mapped|1 target controls covered
6%
ISO 9001:2015
3 source controls mapped|2 target controls covered
6%
ISO/IEC 42001:2023
3 source controls mapped|2 target controls covered
6%
ISO 22301:2019
3 source controls mapped|2 target controls covered
6%
Science Based Targets initiative (SBTi) Corporate Standard
3 source controls mapped|2 target controls covered
6%
COBIT 2019
3 source controls mapped|1 target controls covered
6%
ISO 45001:2018
3 source controls mapped|1 target controls covered
6%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
6%
RICS Professional Standards — Data and Technology in Property
3 source controls mapped|1 target controls covered
6%
ISO 31000:2018
3 source controls mapped|1 target controls covered
6%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
6%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
3 source controls mapped|4 target controls covered
6%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
6%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|3 target controls covered
6%
Online Safety Act 2021 (Australia)
3 source controls mapped|3 target controls covered
6%
ISO/IEC 27006:2024
3 source controls mapped|4 target controls covered
6%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
6%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
6%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
3 source controls mapped|3 target controls covered
6%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|1 target controls covered
6%
WCAG 2.2
3 source controls mapped|1 target controls covered
6%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
6%
ECSS-E-ST-40C: Space Engineering — Software
3 source controls mapped|5 target controls covered
6%
ECSS Software Engineering Standards
3 source controls mapped|5 target controls covered
6%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
3 source controls mapped|1 target controls covered
6%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
3 source controls mapped|4 target controls covered
6%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
3 source controls mapped|2 target controls covered
6%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
3 source controls mapped|1 target controls covered
6%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
6%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|2 target controls covered
6%
UK Building Safety Act 2022
3 source controls mapped|2 target controls covered
6%
Proposal for a Regulation on the European Health Data Space (EHDS)
3 source controls mapped|1 target controls covered
6%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
6%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
3 source controls mapped|1 target controls covered
6%
DO-178C / ED-12C — Software Considerations in Airborne Systems
3 source controls mapped|5 target controls covered
6%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|1 target controls covered
6%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
6%
Jamaica Data Protection Act 2020
3 source controls mapped|3 target controls covered
6%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|4 target controls covered
6%
ETSI ISG QKD - Quantum Key Distribution
3 source controls mapped|3 target controls covered
6%
Florida Digital Bill of Rights (SB 262)
3 source controls mapped|1 target controls covered
6%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
3 source controls mapped|1 target controls covered
6%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|2 target controls covered
6%
Virginia Consumer Data Protection Act (VCDPA)
3 source controls mapped|1 target controls covered
6%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|3 target controls covered
6%
Australia Online Safety Act 2021
3 source controls mapped|4 target controls covered
6%
Mauritius Data Protection Act 2017
3 source controls mapped|2 target controls covered
6%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
3 source controls mapped|3 target controls covered
6%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
6%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
6%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|9 target controls covered
6%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
3 source controls mapped|3 target controls covered
6%
ISO 22318
2 source controls mapped|3 target controls covered
4%
ISO 22316
2 source controls mapped|3 target controls covered
4%
FIRST CSIRT Services Framework and Standards
2 source controls mapped|3 target controls covered
4%
ISO 22301
2 source controls mapped|4 target controls covered
4%
ISO 22317
2 source controls mapped|3 target controls covered
4%
OWASP API Security Top 10:2023
2 source controls mapped|2 target controls covered
4%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
2 source controls mapped|4 target controls covered
4%
US Consumer Product Safety Commission (CPSC) — Connected Product Safety
2 source controls mapped|2 target controls covered
4%
Philippines Data Privacy Act (RA 10173)
2 source controls mapped|4 target controls covered
4%
PropTech Security Standards — Smart Building Cybersecurity
2 source controls mapped|3 target controls covered
4%
NIST Privacy Framework Version 1.0
2 source controls mapped|4 target controls covered
4%
COSO Internal Control — Integrated Framework (2013)
2 source controls mapped|4 target controls covered
4%
ASEAN Guide on AI Governance and Ethics
2 source controls mapped|2 target controls covered
4%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|3 target controls covered
4%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|8 target controls covered
4%
China Data Security Law (DSL)
2 source controls mapped|4 target controls covered
4%
UK Modern Slavery Act 2015
2 source controls mapped|2 target controls covered
4%
Zambia Data Protection Act (2021)
2 source controls mapped|3 target controls covered
4%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|4 target controls covered
4%
India CERT-In Cyber Security Directions 2022
2 source controls mapped|2 target controls covered
4%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
2 source controls mapped|2 target controls covered
4%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
2 source controls mapped|4 target controls covered
4%
CISA Secure by Design Principles
2 source controls mapped|2 target controls covered
4%
Canada Artificial Intelligence and Data Act (AIDA)
2 source controls mapped|3 target controls covered
4%
ICH E6(R3) — Good Clinical Practice
2 source controls mapped|2 target controls covered
4%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|7 target controls covered
4%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
2 source controls mapped|2 target controls covered
4%
Authorised Economic Operator (AEO) Programmes — Global Standards
2 source controls mapped|5 target controls covered
4%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|6 target controls covered
4%
UNESCO Recommendation on the Ethics of AI
2 source controls mapped|5 target controls covered
4%
Solvency II
2 source controls mapped|4 target controls covered
4%
OECD AI Principles
2 source controls mapped|5 target controls covered
4%
Responsible Minerals Initiative (RMI) — Responsible Minerals Assurance Process
2 source controls mapped|6 target controls covered
4%
ICMM Mining Principles (2024 Update)
2 source controls mapped|2 target controls covered
4%
German Supply Chain Due Diligence Act (LkSG)
2 source controls mapped|6 target controls covered
4%
OECD AI Principles (2024 Update)
2 source controls mapped|3 target controls covered
4%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|2 target controls covered
4%
CDP Corporate Questionnaire
2 source controls mapped|3 target controls covered
4%
ISO 26000:2010
2 source controls mapped|3 target controls covered
4%
ASD Essential Eight Maturity Model
1 source controls mapped|2 target controls covered
2%
ITU-T X.805 — Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
2%
Canada's Anti-Spam Legislation (CASL)
1 source controls mapped|1 target controls covered
2%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
2%
EU Better Internet for Kids (BIK+) Strategy
1 source controls mapped|1 target controls covered
2%
ISO 55001
1 source controls mapped|1 target controls covered
2%
ISO 9001
1 source controls mapped|1 target controls covered
2%
ISO 30401
1 source controls mapped|1 target controls covered
2%
ISO 37001
1 source controls mapped|1 target controls covered
2%
ISO 37301
1 source controls mapped|1 target controls covered
2%
GHG Protocol
1 source controls mapped|1 target controls covered
2%
FATF 40 Recommendations
1 source controls mapped|1 target controls covered
2%
Brazil AI Framework
1 source controls mapped|3 target controls covered
2%
China AI Regulations
1 source controls mapped|4 target controls covered
2%
COSO ERM
1 source controls mapped|6 target controls covered
2%
Singapore Model AI Governance Framework (2nd Edition)
1 source controls mapped|1 target controls covered
2%
Australia AI Ethics Framework
1 source controls mapped|4 target controls covered
2%
Colorado Artificial Intelligence Act (proposed SB 24-205)
1 source controls mapped|2 target controls covered
2%
Korea PIPA
1 source controls mapped|1 target controls covered
2%
Japan APPI
1 source controls mapped|1 target controls covered
2%
Colorado Privacy Act (CPA)
1 source controls mapped|1 target controls covered
2%
AML/CTF Act 2006 (Australia)
1 source controls mapped|2 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|3 target controls covered
2%
APRA CPS 220 Risk Management
1 source controls mapped|4 target controls covered
2%
Global Cross-Border Privacy Rules (Global CBPR) Forum
1 source controls mapped|1 target controls covered
2%
Aged Care Quality Standards (Australia)
1 source controls mapped|1 target controls covered
2%
Japan AI Guidelines
1 source controls mapped|4 target controls covered
2%
IEEE 7000
1 source controls mapped|3 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
1 source controls mapped|5 target controls covered
2%
NIST SP 800-37
1 source controls mapped|6 target controls covered
2%
ISO 31000
1 source controls mapped|6 target controls covered
2%
ISO 22000
1 source controls mapped|1 target controls covered
2%
EU Medical Devices Regulation (MDR 2017/745)
1 source controls mapped|1 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
2%
NIST SP 800-39
1 source controls mapped|6 target controls covered
2%
ISO 45001
1 source controls mapped|1 target controls covered
2%
ISO 42001
1 source controls mapped|3 target controls covered
2%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
2%
NIST SP 800-30
1 source controls mapped|6 target controls covered
2%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
1 source controls mapped|1 target controls covered
2%
Singapore AI Governance Framework
1 source controls mapped|4 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|4 target controls covered
2%
UK Online Safety Act 2023
1 source controls mapped|3 target controls covered
2%
EU Digital Services Act
1 source controls mapped|2 target controls covered
2%
FSSC 22000 — Food Safety System Certification
1 source controls mapped|2 target controls covered
2%
ISO 27005
1 source controls mapped|6 target controls covered
2%
Australia IRAP — Information Security Registered Assessors Program
1 source controls mapped|1 target controls covered
2%
UK Age Appropriate Design Code (Children's Code)
1 source controls mapped|1 target controls covered
2%
UNICEF Policy Guidance on AI for Children (2021)
1 source controls mapped|1 target controls covered
2%
SEC Cybersecurity Disclosure Rules
1 source controls mapped|2 target controls covered
2%
UK AI Regulation Framework
1 source controls mapped|3 target controls covered
2%
Equator Principles (EP4, 2020)
1 source controls mapped|1 target controls covered
2%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
2%
SA8000:2014 — Social Accountability Standard
1 source controls mapped|1 target controls covered
2%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
2%
Space ISAC (Information Sharing and Analysis Center) — Threat Framework
1 source controls mapped|1 target controls covered
2%
ISSB Standards
1 source controls mapped|3 target controls covered
2%
EU SFDR (Sustainable Finance Disclosure Regulation)
1 source controls mapped|3 target controls covered
2%
CSRD
1 source controls mapped|3 target controls covered
2%
GRI Standards
1 source controls mapped|3 target controls covered
2%
TCFD Recommendations
1 source controls mapped|3 target controls covered
2%
LEED v4.1 — Green Building Rating System (US Green Building Council)
1 source controls mapped|1 target controls covered
2%
Compare EU GMP Annex 11: Computerised Systems with AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)

Frequently Asked Questions

What is EU GMP Annex 11: Computerised Systems?

EU GMP Annex 11: Computerised Systems is a compliance framework from European Union (EMA/EC) with 20 domains and 48 controls. EU GMP Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in the pharmaceutical industry, including manufacturing, testing, and distribution. Published by the European Commission as part of EudraLex Volume 4, it covers the entire lifecycle of computerised systems, data integrity, risk management, and compliance requirements for regulated operations. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does EU GMP Annex 11: Computerised Systems have?

EU GMP Annex 11: Computerised Systems has 48 controls organised across 20 domains. The largest domains are General Requirements (9 controls), Operational Phase — Data Management (5 controls), Data Integrity (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does EU GMP Annex 11: Computerised Systems map to?

EU GMP Annex 11: Computerised Systems maps to 651 other compliance frameworks. The top mapping partners are AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) (17% coverage), CFTC System Safeguards (17 CFR 37, 38, 39, 49) (17% coverage), ASIC Cyber Resilience Good Practices (17% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with EU GMP Annex 11: Computerised Systems compliance?

Start your EU GMP Annex 11: Computerised Systems compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about EU GMP Annex 11: Computerised Systems requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 48 controls and track your progress.

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