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ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
International (ISPE)
v2nd Edition (2022)
4 domains
17 controls
GAMP 5 (Good Automated Manufacturing Practice, 2nd Edition 2022) is an industry guideline published by ISPE (International Society for Pharmaceutical Engineering). It provides a risk-based approach to the validation and management of computerised systems in the regulated life sciences industry. GAMP 5 is the de facto standard for computerised system validation (CSV) globally. The 2022 revision introduces Critical Thinking and simplifies approaches for modern systems including cloud, SaaS, and AI/ML. Covers the complete system lifecycle and applies to GMP, GLP, GCP, and pharmacovigilance.
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 (4)
Key Concepts and Life Cycle
3 controls
| Code | Title |
|---|---|
| GAMP5-KC-1 | Risk-Based Approach |
| GAMP5-KC-2 | Computerized System Life Cycle |
| GAMP5-KC-3 | Critical Thinking |
Operation and Data Integrity
3 controls
| Code | Title |
|---|---|
| GAMP5-OP-1 | Operational Management |
| GAMP5-OP-2 | Data Integrity (ALCOA+) |
| GAMP5-OP-3 | Retirement and Migration |
Software Categories
8 controls
| Code | Title |
|---|---|
| GAMP5-2.1 | Category 1: Infrastructure Software |
| GAMP5-2.3 | Category 3: Non-Configured Software |
| GAMP5-2.4 | Category 4: Configured Software |
| GAMP5-2.5 | Category 5: Custom Software |
| GAMP5-CAT-1 | Category 1 - Infrastructure Software |
| GAMP5-CAT-3 | Category 3 - Non-Configured Products |
| GAMP5-CAT-4 | Category 4 - Configured Products |
| GAMP5-CAT-5 | Category 5 - Custom Applications |
Specification and Verification
3 controls
| Code | Title |
|---|---|
| GAMP5-SV-1 | User Requirements Specification (URS) |
| GAMP5-SV-2 | Functional Specification (FS) |
| GAMP5-SV-3 | Verification and Testing |
Maps to 474 other frameworks
17 total controls
FAA Cybersecurity Framework for Aviation
5 source controls mapped|4 target controls covered
29%
NAIC Insurance Data Security Model Law (MDL-668)
5 source controls mapped|8 target controls covered
29%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
5 source controls mapped|5 target controls covered
29%
Wisconsin Data Privacy Act (SB 670)
5 source controls mapped|5 target controls covered
29%
Connecticut Data Privacy Act (CTDPA)
5 source controls mapped|5 target controls covered
29%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|5 target controls covered
29%
ICH Q10 — Pharmaceutical Quality System
5 source controls mapped|6 target controls covered
29%
CSA STAR (Security, Trust, Assurance, and Risk)
4 source controls mapped|3 target controls covered
24%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
4 source controls mapped|4 target controls covered
24%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
4 source controls mapped|6 target controls covered
24%
EU Cyber Resilience Act
4 source controls mapped|2 target controls covered
24%
MITRE D3FEND
4 source controls mapped|2 target controls covered
24%
EIOPA Guidelines on ICT Security and Governance (2020)
4 source controls mapped|4 target controls covered
24%
FFIEC IT Examination Handbook
4 source controls mapped|2 target controls covered
24%
ASIC Cyber Resilience Good Practices
4 source controls mapped|3 target controls covered
24%
3GPP Security
4 source controls mapped|2 target controls covered
24%
EU NIS2 Directive — Transport Sector Requirements
4 source controls mapped|3 target controls covered
24%
OWASP ASVS
4 source controls mapped|2 target controls covered
24%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
4 source controls mapped|3 target controls covered
24%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
4 source controls mapped|3 target controls covered
24%
AWS Well-Architected Security Pillar
4 source controls mapped|3 target controls covered
24%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
4 source controls mapped|5 target controls covered
24%
C5 (Germany)
4 source controls mapped|3 target controls covered
24%
Azure Security Benchmark
4 source controls mapped|3 target controls covered
24%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
4 source controls mapped|5 target controls covered
24%
California IoT Security Law
4 source controls mapped|2 target controls covered
24%
EU GMP Annex 11 — Computerised Systems
4 source controls mapped|3 target controls covered
24%
ETSI EN 303 645
4 source controls mapped|2 target controls covered
24%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|3 target controls covered
24%
FedRAMP Rev 5
4 source controls mapped|8 target controls covered
24%
EDM Council DCAM — Data Management Capability Assessment Model
4 source controls mapped|4 target controls covered
24%
CAIQ (CSA)
4 source controls mapped|3 target controls covered
24%
BSIMM
4 source controls mapped|2 target controls covered
24%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
4 source controls mapped|5 target controls covered
24%
APRA CPS 234
4 source controls mapped|2 target controls covered
24%
ISO/IEC 27031:2011
4 source controls mapped|4 target controls covered
24%
EU Taxonomy Regulation (Regulation 2020/852)
4 source controls mapped|5 target controls covered
24%
EU Taxonomy Regulation
4 source controls mapped|4 target controls covered
24%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
4 source controls mapped|4 target controls covered
24%
ISO/IEC 27011:2024
4 source controls mapped|4 target controls covered
24%
BCBS 239
4 source controls mapped|2 target controls covered
24%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|4 target controls covered
24%
DORA
4 source controls mapped|2 target controls covered
24%
ASIS SPC.1-2009 — Organizational Resilience Standard
4 source controls mapped|2 target controls covered
24%
SSAE 18 — Attestation Standards (SOC Reporting)
4 source controls mapped|7 target controls covered
24%
ISO 27018
4 source controls mapped|3 target controls covered
24%
ISO 22320:2018
4 source controls mapped|4 target controls covered
24%
NIST SP 800-161
4 source controls mapped|2 target controls covered
24%
NIST SP 800-144
4 source controls mapped|3 target controls covered
24%
SOC 2
4 source controls mapped|5 target controls covered
24%
TNFD Recommendations
4 source controls mapped|5 target controls covered
24%
South Korea ISMS-P
4 source controls mapped|3 target controls covered
24%
Open Banking Security
4 source controls mapped|2 target controls covered
24%
SLSA
4 source controls mapped|2 target controls covered
24%
NIST SP 800-145
4 source controls mapped|3 target controls covered
24%
FTC GLBA Safeguards Rule (16 CFR Part 314)
4 source controls mapped|5 target controls covered
24%
NIST SP 800-88
4 source controls mapped|2 target controls covered
24%
UNECE WP.29 R156
4 source controls mapped|2 target controls covered
24%
NIST SP 800-160
4 source controls mapped|2 target controls covered
24%
NIST SP 800-92
4 source controls mapped|2 target controls covered
24%
NIST Cybersecurity Framework 2.0
4 source controls mapped|5 target controls covered
24%
GLBA
4 source controls mapped|2 target controls covered
24%
OpenSSF Scorecard
4 source controls mapped|2 target controls covered
24%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|3 target controls covered
24%
SIG (Shared Assessments)
4 source controls mapped|2 target controls covered
24%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
4 source controls mapped|3 target controls covered
24%
UNECE WP.29 R155
4 source controls mapped|2 target controls covered
24%
ISO 26262:2018 — Functional Safety for Road Vehicles
4 source controls mapped|2 target controls covered
24%
OWASP MASVS
4 source controls mapped|2 target controls covered
24%
NIS2 Directive Implementing Acts
4 source controls mapped|4 target controls covered
24%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
4 source controls mapped|3 target controls covered
24%
NIST SP 800-146
4 source controls mapped|3 target controls covered
24%
PCI SSF
4 source controls mapped|2 target controls covered
24%
NIST SP 800-187
4 source controls mapped|2 target controls covered
24%
SANS Incident Handler's Handbook and PICERL Methodology
4 source controls mapped|5 target controls covered
24%
NIST SP 800-82 Rev 3 — Guide to OT Security
4 source controls mapped|6 target controls covered
24%
Defence Security Principles Framework (DSPF)
4 source controls mapped|4 target controls covered
24%
ASD Information Security Manual (ISM)
4 source controls mapped|4 target controls covered
24%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|4 target controls covered
24%
SWIFT CSP
4 source controls mapped|2 target controls covered
24%
ISO 27002:2022
4 source controls mapped|2 target controls covered
24%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|4 target controls covered
24%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|5 target controls covered
24%
ISMAP (Japan)
4 source controls mapped|3 target controls covered
24%
NIST SP 800-128
4 source controls mapped|2 target controls covered
24%
OWASP SAMM
4 source controls mapped|2 target controls covered
24%
OSFI B-13
4 source controls mapped|2 target controls covered
24%
Tennessee Information Protection Act (TIPA)
4 source controls mapped|2 target controls covered
24%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
4 source controls mapped|2 target controls covered
24%
Canada ITSG-33 — IT Security Risk Management
4 source controls mapped|2 target controls covered
24%
New Zealand Information Security Manual (NZISM)
4 source controls mapped|2 target controls covered
24%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
4 source controls mapped|2 target controls covered
24%
South Korea Cloud Security Assurance Program (CSAP)
4 source controls mapped|2 target controls covered
24%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
4 source controls mapped|4 target controls covered
24%
SWIFT CSCF
4 source controls mapped|2 target controls covered
24%
NIST SP 800-137
4 source controls mapped|2 target controls covered
24%
NIST SP 800-183
4 source controls mapped|2 target controls covered
24%
NIST SP 800-115
4 source controls mapped|2 target controls covered
24%
NIST SP 800-123
4 source controls mapped|2 target controls covered
24%
ISO/SAE 21434
4 source controls mapped|2 target controls covered
24%
PCI P2PE
4 source controls mapped|2 target controls covered
24%
DO-178C / ED-12C — Software Considerations in Airborne Systems
4 source controls mapped|5 target controls covered
24%
ISO 27017
4 source controls mapped|3 target controls covered
24%
MTCS (Singapore)
4 source controls mapped|3 target controls covered
24%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
4 source controls mapped|3 target controls covered
24%
ECB TIBER-EU
4 source controls mapped|2 target controls covered
24%
NIST SP 800-61
4 source controls mapped|2 target controls covered
24%
NIST SP 800-150
4 source controls mapped|2 target controls covered
24%
UK Gambling Commission — Cyber Resilience Requirements
4 source controls mapped|5 target controls covered
24%
MITRE ATT&CK
4 source controls mapped|2 target controls covered
24%
NIST SP 800-190
4 source controls mapped|3 target controls covered
24%
NIST SP 800-63
4 source controls mapped|2 target controls covered
24%
TISAX — Trusted Information Security Assessment Exchange
4 source controls mapped|2 target controls covered
24%
ISO 27043
4 source controls mapped|2 target controls covered
24%
NIST SP 800-207
4 source controls mapped|2 target controls covered
24%
PCI PIN Security
4 source controls mapped|2 target controls covered
24%
NIST SP 800-218
4 source controls mapped|2 target controls covered
24%
SSDF (NIST)
4 source controls mapped|2 target controls covered
24%
AICPA SOC 1
4 source controls mapped|2 target controls covered
24%
NIST SP 800-181
4 source controls mapped|2 target controls covered
24%
MAS TRM
4 source controls mapped|2 target controls covered
24%
PTES
4 source controls mapped|2 target controls covered
24%
UK PSTI Act
4 source controls mapped|2 target controls covered
24%
AICPA SOC 3
4 source controls mapped|2 target controls covered
24%
HKMA SPM
4 source controls mapped|2 target controls covered
24%
PSD2 SCA
4 source controls mapped|2 target controls covered
24%
Japan FSA Cybersecurity Guidelines for Financial Institutions
4 source controls mapped|3 target controls covered
24%
EU European Health Data Space (EHDS)
4 source controls mapped|4 target controls covered
24%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
4 source controls mapped|4 target controls covered
24%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
24%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|4 target controls covered
24%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
4 source controls mapped|4 target controls covered
24%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|3 target controls covered
24%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|4 target controls covered
24%
Australia NHMRC National Statement on Ethical Conduct in Human Research
4 source controls mapped|3 target controls covered
24%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
4 source controls mapped|6 target controls covered
24%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|3 target controls covered
24%
EU Clinical Trials Regulation (CTR 536/2014)
4 source controls mapped|4 target controls covered
24%
TEFCA — Trusted Exchange Framework and Common Agreement
4 source controls mapped|4 target controls covered
24%
ISO 8000 — Data Quality
4 source controls mapped|4 target controls covered
24%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|3 target controls covered
24%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|2 target controls covered
24%
BS 65000:2014 — Guidance on Organizational Resilience
4 source controls mapped|2 target controls covered
24%
AASB S2 Climate-related Disclosures
4 source controls mapped|3 target controls covered
24%
Australia My Health Records Act 2012
4 source controls mapped|7 target controls covered
24%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
4 source controls mapped|4 target controls covered
24%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|5 target controls covered
24%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
4 source controls mapped|6 target controls covered
24%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|4 target controls covered
24%
WHO Global Strategy on Digital Health 2020-2025
4 source controls mapped|2 target controls covered
24%
Florida Digital Bill of Rights (SB 262)
4 source controls mapped|2 target controls covered
24%
ECSS Software Engineering Standards (ESA)
3 source controls mapped|3 target controls covered
18%
GLI-33 — Gaming Laboratories International Event Wagering Systems
3 source controls mapped|2 target controls covered
18%
Telecommunications Sector Security Reforms (TSSR)
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27400:2022
3 source controls mapped|3 target controls covered
18%
China Personal Information Protection Law (PIPL)
3 source controls mapped|3 target controls covered
18%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
3 source controls mapped|3 target controls covered
18%
EU Data Act
3 source controls mapped|2 target controls covered
18%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
3 source controls mapped|3 target controls covered
18%
3GPP 5G Security Architecture (TS 33.501)
3 source controls mapped|2 target controls covered
18%
3GPP Security Architecture (TS 33.501 — 5G Security)
3 source controls mapped|5 target controls covered
18%
ISO/IEC 29134:2023
3 source controls mapped|3 target controls covered
18%
ISO/IEC 27014:2020
3 source controls mapped|3 target controls covered
18%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
18%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
18%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
3 source controls mapped|3 target controls covered
18%
21 CFR Part 58 — Good Laboratory Practice (GLP)
3 source controls mapped|2 target controls covered
18%
OWASP DevSecOps Maturity Model (DSOMM)
3 source controls mapped|3 target controls covered
18%
ISO/IEC 29147:2018
3 source controls mapped|3 target controls covered
18%
IEC 62351 — Power Systems Communication Security
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
18%
FBI CJIS Security Policy
3 source controls mapped|2 target controls covered
18%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|3 target controls covered
18%
EU ePrivacy Directive (2002/58/EC)
3 source controls mapped|4 target controls covered
18%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
18%
FTC Health Breach Notification Rule
3 source controls mapped|3 target controls covered
18%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
3 source controls mapped|3 target controls covered
18%
EU Carbon Border Adjustment Mechanism (CBAM)
3 source controls mapped|4 target controls covered
18%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
3 source controls mapped|4 target controls covered
18%
EU Digital Services Act — Online Gaming Platform Requirements
3 source controls mapped|1 target controls covered
18%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
3 source controls mapped|3 target controls covered
18%
EU European Media Freedom Act (EMFA)
3 source controls mapped|5 target controls covered
18%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
3 source controls mapped|5 target controls covered
18%
EU Pay Transparency Directive (Directive 2023/970)
3 source controls mapped|6 target controls covered
18%
EU Platform Work Directive (Directive 2024/2831)
3 source controls mapped|6 target controls covered
18%
EU Product Liability Directive (Directive (EU) 2024/2853)
3 source controls mapped|6 target controls covered
18%
EU Seveso III Directive (Directive 2012/18/EU)
3 source controls mapped|5 target controls covered
18%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
3 source controls mapped|2 target controls covered
18%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|3 target controls covered
18%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
3 source controls mapped|3 target controls covered
18%
MiFID II / MiFIR
3 source controls mapped|1 target controls covered
18%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
3 source controls mapped|6 target controls covered
18%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
3 source controls mapped|4 target controls covered
18%
Costa Rica Personal Data Protection Law (Law No. 8968)
3 source controls mapped|4 target controls covered
18%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
3 source controls mapped|4 target controls covered
18%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|4 target controls covered
18%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
3 source controls mapped|3 target controls covered
18%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|4 target controls covered
18%
Uzbekistan Law on Personal Data (No. ZRU-547)
3 source controls mapped|4 target controls covered
18%
Georgia Law on Personal Data Protection (2012)
3 source controls mapped|4 target controls covered
18%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
3 source controls mapped|4 target controls covered
18%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
3 source controls mapped|4 target controls covered
18%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|6 target controls covered
18%
Montenegro Law on Personal Data Protection (2023)
3 source controls mapped|6 target controls covered
18%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
18%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|6 target controls covered
18%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|5 target controls covered
18%
Serbia Law on Personal Data Protection (2018)
3 source controls mapped|4 target controls covered
18%
Lithuania Law on Legal Protection of Personal Data (2018)
3 source controls mapped|2 target controls covered
18%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
3 source controls mapped|6 target controls covered
18%
Malta Data Protection Act (Cap. 586, 2018)
3 source controls mapped|6 target controls covered
18%
Oman Personal Data Protection Law (Royal Decree 6/2022)
3 source controls mapped|4 target controls covered
18%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
3 source controls mapped|4 target controls covered
18%
South Korea Personal Information Protection Act (PIPA)
3 source controls mapped|5 target controls covered
18%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
3 source controls mapped|6 target controls covered
18%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
3 source controls mapped|4 target controls covered
18%
ASEAN Data Management Framework
3 source controls mapped|2 target controls covered
18%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
3 source controls mapped|5 target controls covered
18%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|5 target controls covered
18%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|3 target controls covered
18%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
18%
HL7 FHIR Security Framework
3 source controls mapped|1 target controls covered
18%
OWASP Top 10:2025
3 source controls mapped|1 target controls covered
18%
COBIT 2019
3 source controls mapped|1 target controls covered
18%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|1 target controls covered
18%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|1 target controls covered
18%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
3 source controls mapped|4 target controls covered
18%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
3 source controls mapped|3 target controls covered
18%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
18%
EU Markets in Crypto-Assets Regulation (MiCA)
3 source controls mapped|5 target controls covered
18%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
18%
EN 50126/50128/50129 — Railway RAMS and Safety
3 source controls mapped|3 target controls covered
18%
Angola Personal Data Protection Law (Law No. 22/11)
3 source controls mapped|4 target controls covered
18%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
18%
EU AI Liability Directive
3 source controls mapped|4 target controls covered
18%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
3 source controls mapped|5 target controls covered
18%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
3 source controls mapped|2 target controls covered
18%
EU Web Accessibility Directive (Directive 2016/2102)
3 source controls mapped|3 target controls covered
18%
African Union Malabo Convention
3 source controls mapped|3 target controls covered
18%
Morocco Data Protection Law (09-08)
3 source controls mapped|4 target controls covered
18%
Chile Personal Data Protection Law (Law No. 21.719)
3 source controls mapped|3 target controls covered
18%
Peru Personal Data Protection Law (Law No. 29733)
3 source controls mapped|3 target controls covered
18%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|3 target controls covered
18%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
3 source controls mapped|3 target controls covered
18%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
18%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
3 source controls mapped|5 target controls covered
18%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
3 source controls mapped|3 target controls covered
18%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|5 target controls covered
18%
RICS Professional Standards — Data and Technology in Property
3 source controls mapped|1 target controls covered
18%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
18%
Digital Economy Partnership Agreement (DEPA)
3 source controls mapped|2 target controls covered
18%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
3 source controls mapped|2 target controls covered
18%
RBI Cybersecurity Framework for Banks
3 source controls mapped|2 target controls covered
18%
Kuwait National Cybersecurity Framework
3 source controls mapped|2 target controls covered
18%
EDM Council CDMC — Cloud Data Management Capabilities Framework
3 source controls mapped|3 target controls covered
18%
Science Based Targets initiative (SBTi) Corporate Standard
3 source controls mapped|2 target controls covered
18%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
18%
China Cybersecurity Law (CSL)
3 source controls mapped|1 target controls covered
18%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|3 target controls covered
18%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|3 target controls covered
18%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|1 target controls covered
18%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
3 source controls mapped|3 target controls covered
18%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
3 source controls mapped|4 target controls covered
18%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|4 target controls covered
18%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|4 target controls covered
18%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|5 target controls covered
18%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
3 source controls mapped|5 target controls covered
18%
ICAO Annex 17 — Aviation Security (AVSEC)
3 source controls mapped|3 target controls covered
18%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|4 target controls covered
18%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
18%
SQF Code Edition 9 — Safe Quality Food
3 source controls mapped|1 target controls covered
18%
ISO/IEC 30111:2019
3 source controls mapped|3 target controls covered
18%
Armenia Law on Protection of Personal Data (2015)
3 source controls mapped|3 target controls covered
18%
ISO/IEC 38500:2024 — Governance of IT
3 source controls mapped|3 target controls covered
18%
APRA Prudential Standard CPS 234 — Information Security (Australia)
3 source controls mapped|1 target controls covered
18%
NIST AI Risk Management Framework (AI RMF 1.0)
3 source controls mapped|2 target controls covered
18%
NIST AI 600-1 Generative AI Profile
3 source controls mapped|2 target controls covered
18%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
18%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
3 source controls mapped|4 target controls covered
18%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
3 source controls mapped|5 target controls covered
18%
21 CFR Part 211 — Current Good Manufacturing Practice
3 source controls mapped|1 target controls covered
18%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
3 source controls mapped|2 target controls covered
18%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
3 source controls mapped|3 target controls covered
18%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
3 source controls mapped|3 target controls covered
18%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|3 target controls covered
18%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
3 source controls mapped|3 target controls covered
18%
Laos Law on Prevention and Combating Cybercrime (2015)
3 source controls mapped|4 target controls covered
18%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
3 source controls mapped|2 target controls covered
18%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
3 source controls mapped|2 target controls covered
18%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|2 target controls covered
18%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
3 source controls mapped|7 target controls covered
18%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|5 target controls covered
18%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|4 target controls covered
18%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|4 target controls covered
18%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
3 source controls mapped|2 target controls covered
18%
Botswana Data Protection Act (2024)
3 source controls mapped|5 target controls covered
18%
Fiji Data Protection Bill (2020)
3 source controls mapped|5 target controls covered
18%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|4 target controls covered
18%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|4 target controls covered
18%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 target controls covered
18%
South Korea Credit Information Act
3 source controls mapped|1 target controls covered
18%
ISO 37000:2021 — Governance of Organizations
3 source controls mapped|3 target controls covered
18%
Singapore Cybersecurity Act 2018
3 source controls mapped|1 target controls covered
18%
Cyber Security Act 2024 (Australia)
3 source controls mapped|1 target controls covered
18%
NIST SP 800-124 Rev 2 — Mobile Device Security
3 source controls mapped|3 target controls covered
18%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
3 source controls mapped|3 target controls covered
18%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
3 source controls mapped|3 target controls covered
18%
ECB TIBER-EU Framework
3 source controls mapped|1 target controls covered
18%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
18%
Virginia Consumer Data Protection Act (VCDPA)
3 source controls mapped|1 target controls covered
18%
IRS Publication 1075 — Tax Information Security Guidelines
3 source controls mapped|1 target controls covered
18%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
3 source controls mapped|1 target controls covered
18%
COSO Enterprise Risk Management (ERM) Framework (2017)
3 source controls mapped|2 target controls covered
18%
Brunei Personal Data Protection Order 2024 (PDPO)
3 source controls mapped|6 target controls covered
18%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
3 source controls mapped|5 target controls covered
18%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|3 target controls covered
18%
Australia Online Safety Act 2021
3 source controls mapped|4 target controls covered
18%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|4 target controls covered
18%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|4 target controls covered
18%
Jamaica Data Protection Act 2020
3 source controls mapped|3 target controls covered
18%
Mauritius Data Protection Act 2017
3 source controls mapped|2 target controls covered
18%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
18%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|2 target controls covered
18%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|4 target controls covered
18%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
3 source controls mapped|3 target controls covered
18%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|4 target controls covered
18%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
3 source controls mapped|4 target controls covered
18%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|1 target controls covered
18%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
18%
ISO 20400:2017 — Sustainable Procurement
3 source controls mapped|2 target controls covered
18%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
18%
AS9100D — Aerospace Quality Management System
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27003:2017
3 source controls mapped|1 target controls covered
18%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
18%
MTCS — Multi-Tier Cloud Security (Singapore)
3 source controls mapped|2 target controls covered
18%
BREEAM — Building Research Establishment Environmental Assessment Method
3 source controls mapped|1 target controls covered
18%
AICPA Privacy Management Framework (PMF)
3 source controls mapped|2 target controls covered
18%
ISO/IEC 23894:2023
3 source controls mapped|3 target controls covered
18%
ISO 28001:2007 Supply Chain Security Management
3 source controls mapped|1 target controls covered
18%
Online Safety Act 2021 (Australia)
3 source controls mapped|3 target controls covered
18%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
18%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|2 target controls covered
18%
PCI DSS v4.0
3 source controls mapped|3 target controls covered
18%
ISO/IEC 27006:2024
3 source controls mapped|3 target controls covered
18%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|3 target controls covered
18%
ISO/IEC 25012:2008 — Data Quality Model
3 source controls mapped|2 target controls covered
18%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
18%
O-RAN Alliance Security Specifications (O-RAN.WG11)
3 source controls mapped|3 target controls covered
18%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
18%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
18%
SWIFT Customer Security Programme (CSP)
3 source controls mapped|2 target controls covered
18%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
3 source controls mapped|1 target controls covered
18%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
3 source controls mapped|1 target controls covered
18%
ISO 56002
3 source controls mapped|4 target controls covered
18%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
3 source controls mapped|1 target controls covered
18%
UK Telecommunications (Security) Act 2021
3 source controls mapped|1 target controls covered
18%
IAIS Insurance Core Principles (ICPs)
3 source controls mapped|1 target controls covered
18%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
3 source controls mapped|2 target controls covered
18%
ISO 41001:2018 — Facility Management Systems
3 source controls mapped|3 target controls covered
18%
ISO 39001:2012 — Road Traffic Safety Management
3 source controls mapped|3 target controls covered
18%
ISO 37002:2021 — Whistleblowing Management Systems
3 source controls mapped|3 target controls covered
18%
ISO 50001:2018 — Energy Management Systems
3 source controls mapped|3 target controls covered
18%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
3 source controls mapped|3 target controls covered
18%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
3 source controls mapped|1 target controls covered
18%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|2 target controls covered
18%
EU Digital Markets Act
3 source controls mapped|1 target controls covered
18%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
3 source controls mapped|1 target controls covered
18%
EAR — Export Administration Regulations
3 source controls mapped|1 target controls covered
18%
European Accessibility Act (Directive (EU) 2019/882)
3 source controls mapped|1 target controls covered
18%
EU Deforestation-Free Products Regulation (EUDR)
3 source controls mapped|1 target controls covered
18%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
3 source controls mapped|1 target controls covered
18%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
3 source controls mapped|1 target controls covered
18%
US ITAR and EAR — Export Control and Data Security
3 source controls mapped|1 target controls covered
18%
Australia Consumer Data Right — Banking (CDR)
3 source controls mapped|1 target controls covered
18%
Australia eSafety Commissioner — Online Safety Expectations for Industry
3 source controls mapped|1 target controls covered
18%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
18%
UK Building Safety Act 2022
3 source controls mapped|2 target controls covered
18%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
3 source controls mapped|3 target controls covered
18%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|2 target controls covered
18%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
3 source controls mapped|2 target controls covered
18%
Bermuda Personal Information Protection Act 2016 (PIPA)
3 source controls mapped|2 target controls covered
18%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|1 target controls covered
18%
EU PSD3 and Payment Services Regulation (Proposed)
3 source controls mapped|3 target controls covered
18%
US OFAC Sanctions Compliance Framework
3 source controls mapped|1 target controls covered
18%
WCAG 2.2
3 source controls mapped|1 target controls covered
18%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
3 source controls mapped|1 target controls covered
18%
IATF 16949:2016 — Quality Management System for Automotive Production
3 source controls mapped|2 target controls covered
18%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
18%
South Korea PIPA
3 source controls mapped|1 target controls covered
18%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
2 source controls mapped|7 target controls covered
12%
HIPAA Security Rule
2 source controls mapped|7 target controls covered
12%
Australian Energy Sector Cyber Security Framework (AESCSF)
2 source controls mapped|2 target controls covered
12%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
2 source controls mapped|5 target controls covered
12%
Washington My Health My Data Act (MHMD)
2 source controls mapped|2 target controls covered
12%
DO-326A
1 source controls mapped|4 target controls covered
6%
FIRST CSIRT Services Framework and Standards
1 source controls mapped|1 target controls covered
6%
CSA CCM v4
1 source controls mapped|5 target controls covered
6%
BIMCO Cyber Security
1 source controls mapped|4 target controls covered
6%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
1 source controls mapped|1 target controls covered
6%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
6%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
6%
C2M2
1 source controls mapped|4 target controls covered
6%
FISMA
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|3 target controls covered
6%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|3 target controls covered
6%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
1 source controls mapped|1 target controls covered
6%
ASD Essential Eight Maturity Model
1 source controls mapped|3 target controls covered
6%
API 1164
1 source controls mapped|4 target controls covered
6%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
6%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
6%
Spain ENS
1 source controls mapped|1 target controls covered
6%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
6%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
6%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
6%
CMMC 2.0
1 source controls mapped|1 target controls covered
6%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|2 target controls covered
6%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
1 source controls mapped|1 target controls covered
6%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
6%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|3 target controls covered
6%
NIST SP 800-53 Rev 5
1 source controls mapped|3 target controls covered
6%
ISO 27001:2022
1 source controls mapped|3 target controls covered
6%
TSA Pipeline Security
1 source controls mapped|4 target controls covered
6%
ISO 37001
1 source controls mapped|1 target controls covered
6%
SASB Standards (ISSB Integrated)
1 source controls mapped|1 target controls covered
6%
SASB Standards
1 source controls mapped|1 target controls covered
6%
NIS2 Directive
1 source controls mapped|4 target controls covered
6%
ISO 27019
1 source controls mapped|4 target controls covered
6%
ISO 22301
1 source controls mapped|2 target controls covered
6%
ISO 22316
1 source controls mapped|2 target controls covered
6%
NERC CIP
1 source controls mapped|4 target controls covered
6%
DISA Security Technical Implementation Guides (STIGs)
1 source controls mapped|1 target controls covered
6%
Oman National Cybersecurity Framework
1 source controls mapped|2 target controls covered
6%
ISO 37301
1 source controls mapped|1 target controls covered
6%
ISO 22317
1 source controls mapped|2 target controls covered
6%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|1 target controls covered
6%
C-TPAT — Customs-Trade Partnership Against Terrorism
1 source controls mapped|1 target controls covered
6%
NIST SP 1800-32
1 source controls mapped|4 target controls covered
6%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|2 target controls covered
6%
Lloyd's Minimum Standards — Cyber Security
1 source controls mapped|2 target controls covered
6%
Colorado Privacy Act (CPA)
1 source controls mapped|1 target controls covered
6%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|2 target controls covered
6%
ISO 30401
1 source controls mapped|1 target controls covered
6%
NIST Privacy Framework 1.0
1 source controls mapped|4 target controls covered
6%
NIST SP 800-172
1 source controls mapped|1 target controls covered
6%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
1 source controls mapped|1 target controls covered
6%
ISO 19011
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171
1 source controls mapped|1 target controls covered
6%
IEC 62443
1 source controls mapped|4 target controls covered
6%
IEEE 1686
1 source controls mapped|4 target controls covered
6%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
6%
ISO 20000-1
1 source controls mapped|1 target controls covered
6%
ISO 22318
1 source controls mapped|2 target controls covered
6%
ISO 55001
1 source controls mapped|1 target controls covered
6%
NABERS — National Australian Built Environment Rating System
1 source controls mapped|1 target controls covered
6%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
6%
ISO 9001
1 source controls mapped|1 target controls covered
6%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|1 target controls covered
6%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
6%
ITIL 4
1 source controls mapped|1 target controls covered
6%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
6%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
6%
Aged Care Quality Standards (Australia)
1 source controls mapped|3 target controls covered
6%
ICH E6(R3) — Good Clinical Practice
1 source controls mapped|3 target controls covered
6%
Colorado AI Act (SB 24-205)
1 source controls mapped|1 target controls covered
6%
WELL Building Standard v2 (International WELL Building Institute)
1 source controls mapped|1 target controls covered
6%
CDP (formerly Carbon Disclosure Project)
1 source controls mapped|1 target controls covered
6%
HITECH Act
1 source controls mapped|3 target controls covered
6%
EU Medical Devices Regulation (MDR 2017/745)
1 source controls mapped|3 target controls covered
6%
MDS2 (Medical Device)
1 source controls mapped|3 target controls covered
6%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|1 target controls covered
6%
Security of Critical Infrastructure Act 2018 (SOCI)
1 source controls mapped|1 target controls covered
6%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|1 target controls covered
6%
Frequently Asked Questions
What is ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems?
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems is a compliance framework from International (ISPE) with 4 domains and 17 controls. GAMP 5 (Good Automated Manufacturing Practice, 2nd Edition 2022) is an industry guideline published by ISPE (International Society for Pharmaceutical Engineering). It provides a risk-based approach to the validation and management of computerised systems in the regulated life sciences industry. GAMP 5 is the de facto standard for computerised system validation (CSV) globally. The 2022 revision introduces Critical Thinking and simplifies approaches for modern systems including cloud, SaaS, and AI/ML. Covers the complete system lifecycle and applies to GMP, GLP, GCP, and pharmacovigilance. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems have?
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems has 17 controls organised across 4 domains. The largest domains are Software Categories (8 controls), Key Concepts and Life Cycle (3 controls), Operation and Data Integrity (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems map to?
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems maps to 474 other compliance frameworks. The top mapping partners are FAA Cybersecurity Framework for Aviation (29% coverage), NAIC Insurance Data Security Model Law (MDL-668) (29% coverage), Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA) (29% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems compliance?
Start your ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 17 controls and track your progress.
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