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ICH Q10 — Pharmaceutical Quality System

International (ICH)
v2008 (current)
3 domains
15 controls

ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system (PQS) based on ISO quality concepts, applicable GMP regulations, and ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). It establishes a system for lifecycle management of pharmaceutical products covering development, technology transfer, commercial manufacturing, and product discontinuation. Adopted by FDA, EMA, and PMDA.

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 (3)

Section 1 - Pharmaceutical Quality System

4 controls
Controls in the Section 1 - Pharmaceutical Quality System domain of ICH Q10 — Pharmaceutical Quality System4 controls
CodeTitle
Q10-1.1Scope
Q10-1.2ICH Q10 Objectives
Q10-1.3Enablers: Knowledge Management
Q10-1.4Enablers: Quality Risk Management

Section 2 - Management Responsibility

7 controls
Controls in the Section 2 - Management Responsibility domain of ICH Q10 — Pharmaceutical Quality System7 controls
CodeTitle
Q10-2.1Management Commitment
Q10-2.2Quality Policy
Q10-2.3Quality Planning
Q10-2.4Resource Management
Q10-2.5Internal Communication
Q10-2.6Management Review
Q10-2.7Management of Outsourced Activities and Purchased Materials

Section 3 - Continual Improvement of Process Performance and Product Quality

4 controls
Controls in the Section 3 - Continual Improvement of Process Performance and Product Quality domain of ICH Q10 — Pharmaceutical Quality System4 controls
CodeTitle
Q10-3.1Lifecycle Stage Goals
Q10-3.2Corrective Action and Preventive Action (CAPA)
Q10-3.3Change Management
Q10-3.4Management Review of Process Performance and Product Quality

Maps to 525 other frameworks

15 total controls
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
8 source controls mapped|6 target controls covered
53%
53%
BS 65000:2014 — Guidance on Organizational Resilience
8 source controls mapped|7 target controls covered
53%
FDA Quality Management System Regulation (QMSR)
7 source controls mapped|7 target controls covered
47%
ILO Nursing Personnel Convention C149 (1977)
7 source controls mapped|7 target controls covered
47%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
7 source controls mapped|9 target controls covered
47%
ISO 8000 — Data Quality
7 source controls mapped|7 target controls covered
47%
FATF Recommendation 16 — Virtual Asset Travel Rule
7 source controls mapped|6 target controls covered
47%
Privacy by Design (PbD) — Seven Foundational Principles
7 source controls mapped|5 target controls covered
47%
TISAX — Trusted Information Security Assessment Exchange
7 source controls mapped|7 target controls covered
47%
AASB S2 Climate-related Disclosures
7 source controls mapped|8 target controls covered
47%
GAMP 5 — Good Automated Manufacturing Practice
7 source controls mapped|7 target controls covered
47%
FAA Cybersecurity Framework for Aviation
7 source controls mapped|9 target controls covered
47%
IEC 62304:2015 Medical Device Software Lifecycle Processes
6 source controls mapped|9 target controls covered
40%
South Korea ISMS-P
6 source controls mapped|4 target controls covered
40%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
6 source controls mapped|6 target controls covered
40%
ISO 28001:2007 Supply Chain Security Management
6 source controls mapped|9 target controls covered
40%
ISO 20400:2017 — Sustainable Procurement
6 source controls mapped|7 target controls covered
40%
AS9100D — Aerospace Quality Management System
6 source controls mapped|10 target controls covered
40%
ISO/IEC 27003:2017
6 source controls mapped|10 target controls covered
40%
40%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
6 source controls mapped|7 target controls covered
40%
NIST SP 800-82 Rev 3 — Guide to OT Security
6 source controls mapped|6 target controls covered
40%
EU GMP Annex 11 — Computerised Systems
6 source controls mapped|4 target controls covered
40%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
6 source controls mapped|4 target controls covered
40%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
6 source controls mapped|7 target controls covered
40%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
6 source controls mapped|5 target controls covered
40%
IEC 60601-1 — Medical Electrical Equipment Safety
6 source controls mapped|5 target controls covered
40%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
6 source controls mapped|7 target controls covered
40%
Modern Slavery Act 2018 (Australia)
6 source controls mapped|6 target controls covered
40%
Canada ITSG-33 — IT Security Risk Management
6 source controls mapped|5 target controls covered
40%
New Zealand Information Security Manual (NZISM)
6 source controls mapped|5 target controls covered
40%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
6 source controls mapped|5 target controls covered
40%
South Korea Cloud Security Assurance Program (CSAP)
6 source controls mapped|5 target controls covered
40%
Australian Energy Sector Cyber Security Framework (AESCSF)
6 source controls mapped|8 target controls covered
40%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
6 source controls mapped|6 target controls covered
40%
EIOPA Guidelines on ICT Security and Governance (2020)
6 source controls mapped|6 target controls covered
40%
ISO 41001:2018 — Facility Management Systems
5 source controls mapped|8 target controls covered
33%
ISO 39001:2012 — Road Traffic Safety Management
5 source controls mapped|8 target controls covered
33%
ISO 50001:2018 — Energy Management Systems
5 source controls mapped|8 target controls covered
33%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
5 source controls mapped|8 target controls covered
33%
ASEAN Data Management Framework
5 source controls mapped|7 target controls covered
33%
IATF 16949:2016 — Quality Management System for Automotive Production
5 source controls mapped|5 target controls covered
33%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
5 source controls mapped|2 target controls covered
33%
EU Medical Devices Regulation (MDR 2017/745)
5 source controls mapped|6 target controls covered
33%
Aged Care Quality Standards (Australia)
5 source controls mapped|4 target controls covered
33%
SQF Code Edition 9 — Safe Quality Food
5 source controls mapped|3 target controls covered
33%
ICH E6(R3) — Good Clinical Practice
5 source controls mapped|5 target controls covered
33%
BRCGS Global Standard for Food Safety Issue 9
5 source controls mapped|6 target controls covered
33%
DO-178C / ED-12C — Software Considerations in Airborne Systems
5 source controls mapped|6 target controls covered
33%
TEFCA — Trusted Exchange Framework and Common Agreement
5 source controls mapped|4 target controls covered
33%
Australia My Health Records Act 2012
5 source controls mapped|7 target controls covered
33%
TNFD Recommendations
5 source controls mapped|8 target controls covered
33%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
5 source controls mapped|4 target controls covered
33%
EU Clinical Trials Regulation (CTR 536/2014)
5 source controls mapped|4 target controls covered
33%
EU Taxonomy Regulation (Regulation 2020/852)
5 source controls mapped|6 target controls covered
33%
African Union Malabo Convention
5 source controls mapped|5 target controls covered
33%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
5 source controls mapped|5 target controls covered
33%
Costa Rica Personal Data Protection Law (Law No. 8968)
5 source controls mapped|6 target controls covered
33%
Georgia Law on Personal Data Protection (2012)
5 source controls mapped|6 target controls covered
33%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
5 source controls mapped|6 target controls covered
33%
Oman Personal Data Protection Law (Royal Decree 6/2022)
5 source controls mapped|6 target controls covered
33%
FedRAMP Rev 5
5 source controls mapped|9 target controls covered
33%
Australia NHMRC National Statement on Ethical Conduct in Human Research
5 source controls mapped|3 target controls covered
33%
NAIC Insurance Data Security Model Law (MDL-668)
5 source controls mapped|6 target controls covered
33%
EDM Council DCAM — Data Management Capability Assessment Model
5 source controls mapped|5 target controls covered
33%
EU Digital Services Act — Online Gaming Platform Requirements
5 source controls mapped|3 target controls covered
33%
33%
Lithuania Law on Legal Protection of Personal Data (2018)
5 source controls mapped|4 target controls covered
33%
South Korea Personal Information Protection Act (PIPA)
5 source controls mapped|7 target controls covered
33%
3GPP Security Architecture (TS 33.501 — 5G Security)
5 source controls mapped|8 target controls covered
33%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
5 source controls mapped|5 target controls covered
33%
NIST Cybersecurity Framework 2.0
5 source controls mapped|7 target controls covered
33%
33%
FTC Health Breach Notification Rule
5 source controls mapped|5 target controls covered
33%
EU European Health Data Space (EHDS)
5 source controls mapped|4 target controls covered
33%
NIS2 Directive Implementing Acts
5 source controls mapped|8 target controls covered
33%
FBI CJIS Security Policy
5 source controls mapped|3 target controls covered
33%
Defence Security Principles Framework (DSPF)
5 source controls mapped|10 target controls covered
33%
Protective Security Policy Framework (PSPF) Release 2024
5 source controls mapped|12 target controls covered
33%
Connecticut Data Privacy Act (CTDPA)
5 source controls mapped|4 target controls covered
33%
Illinois Biometric Information Privacy Act (BIPA)
5 source controls mapped|4 target controls covered
33%
NIST AI Risk Management Framework (AI RMF 1.0)
5 source controls mapped|4 target controls covered
33%
NIST AI 600-1 Generative AI Profile
5 source controls mapped|4 target controls covered
33%
ISO/IEC 23894:2023
5 source controls mapped|7 target controls covered
33%
CDP (formerly Carbon Disclosure Project)
5 source controls mapped|4 target controls covered
33%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
5 source controls mapped|5 target controls covered
33%
Japan FSA Cybersecurity Guidelines for Financial Institutions
5 source controls mapped|5 target controls covered
33%
RBI Cybersecurity Framework for Banks
5 source controls mapped|5 target controls covered
33%
Kuwait National Cybersecurity Framework
5 source controls mapped|5 target controls covered
33%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
5 source controls mapped|4 target controls covered
33%
Wisconsin Data Privacy Act (SB 670)
5 source controls mapped|4 target controls covered
33%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|4 target controls covered
33%
GLI-33 — Gaming Laboratories International Event Wagering Systems
5 source controls mapped|4 target controls covered
33%
Telecommunications Sector Security Reforms (TSSR)
5 source controls mapped|3 target controls covered
33%
Notifiable Data Breaches Scheme (Australia)
5 source controls mapped|4 target controls covered
33%
OWASP Top 10:2025
5 source controls mapped|3 target controls covered
33%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
5 source controls mapped|3 target controls covered
33%
EU Digital Markets Act
5 source controls mapped|3 target controls covered
33%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
5 source controls mapped|3 target controls covered
33%
EAR — Export Administration Regulations
5 source controls mapped|3 target controls covered
33%
European Accessibility Act (Directive (EU) 2019/882)
5 source controls mapped|3 target controls covered
33%
EU Deforestation-Free Products Regulation (EUDR)
5 source controls mapped|3 target controls covered
33%
US ITAR and EAR — Export Control and Data Security
5 source controls mapped|3 target controls covered
33%
US SEC Digital Assets and Crypto Regulatory Framework
5 source controls mapped|5 target controls covered
33%
Australia Consumer Data Right — Banking (CDR)
5 source controls mapped|3 target controls covered
33%
Australia eSafety Commissioner — Online Safety Expectations for Industry
5 source controls mapped|3 target controls covered
33%
UK Gambling Commission — Cyber Resilience Requirements
5 source controls mapped|5 target controls covered
33%
WHO Global Strategy on Digital Health 2020-2025
5 source controls mapped|2 target controls covered
33%
Security of Critical Infrastructure Act 2018 (SOCI)
5 source controls mapped|5 target controls covered
33%
UK Telecommunications (Security) Act 2021
5 source controls mapped|7 target controls covered
33%
ASD Information Security Manual (ISM)
5 source controls mapped|6 target controls covered
33%
SSAE 18 — Attestation Standards (SOC Reporting)
5 source controls mapped|5 target controls covered
33%
Florida Digital Bill of Rights (SB 262)
5 source controls mapped|2 target controls covered
33%
ECB TIBER-EU Framework
5 source controls mapped|3 target controls covered
33%
ISO 56002
4 source controls mapped|7 target controls covered
27%
ISO 37002:2021 — Whistleblowing Management Systems
4 source controls mapped|6 target controls covered
27%
AICPA Privacy Management Framework (PMF)
4 source controls mapped|2 target controls covered
27%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
4 source controls mapped|4 target controls covered
27%
ITAR — International Traffic in Arms Regulations
4 source controls mapped|3 target controls covered
27%
ISO/IEC 27014:2020
4 source controls mapped|4 target controls covered
27%
ICAO Annex 17 — Aviation Security (AVSEC)
4 source controls mapped|4 target controls covered
27%
IRS Publication 1075 — Tax Information Security Guidelines
4 source controls mapped|1 target controls covered
27%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|2 target controls covered
27%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|3 target controls covered
27%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
4 source controls mapped|7 target controls covered
27%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
27%
PSD2 SCA
4 source controls mapped|4 target controls covered
27%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
4 source controls mapped|3 target controls covered
27%
EU PSD3 and Payment Services Regulation (Proposed)
4 source controls mapped|4 target controls covered
27%
ISO 27018
4 source controls mapped|2 target controls covered
27%
ISO/IEC 27006:2024
4 source controls mapped|4 target controls covered
27%
O-RAN Alliance Security Specifications (O-RAN.WG11)
4 source controls mapped|4 target controls covered
27%
EU Carbon Border Adjustment Mechanism (CBAM)
4 source controls mapped|5 target controls covered
27%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
4 source controls mapped|5 target controls covered
27%
27%
EU European Media Freedom Act (EMFA)
4 source controls mapped|6 target controls covered
27%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
4 source controls mapped|6 target controls covered
27%
EU NIS2 Directive — Transport Sector Requirements
4 source controls mapped|3 target controls covered
27%
EU Pay Transparency Directive (Directive 2023/970)
4 source controls mapped|7 target controls covered
27%
EU Platform Work Directive (Directive 2024/2831)
4 source controls mapped|7 target controls covered
27%
EU Product Liability Directive (Directive (EU) 2024/2853)
4 source controls mapped|7 target controls covered
27%
EU Seveso III Directive (Directive 2012/18/EU)
4 source controls mapped|6 target controls covered
27%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
4 source controls mapped|3 target controls covered
27%
EU ePrivacy Directive (2002/58/EC)
4 source controls mapped|5 target controls covered
27%
Morocco Data Protection Law (09-08)
4 source controls mapped|5 target controls covered
27%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
4 source controls mapped|7 target controls covered
27%
Peru Personal Data Protection Law (Law No. 29733)
4 source controls mapped|4 target controls covered
27%
Pakistan Personal Data Protection Bill 2023
4 source controls mapped|4 target controls covered
27%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
4 source controls mapped|5 target controls covered
27%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
4 source controls mapped|4 target controls covered
27%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
4 source controls mapped|5 target controls covered
27%
Uzbekistan Law on Personal Data (No. ZRU-547)
4 source controls mapped|5 target controls covered
27%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
4 source controls mapped|5 target controls covered
27%
Montenegro Law on Personal Data Protection (2023)
4 source controls mapped|7 target controls covered
27%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
4 source controls mapped|7 target controls covered
27%
Portugal Law No. 58/2019 — Data Protection Implementation Act
4 source controls mapped|7 target controls covered
27%
Malta Data Protection Act (Cap. 586, 2018)
4 source controls mapped|7 target controls covered
27%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
4 source controls mapped|5 target controls covered
27%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
4 source controls mapped|7 target controls covered
27%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
4 source controls mapped|5 target controls covered
27%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
4 source controls mapped|6 target controls covered
27%
NIST SP 800-146
4 source controls mapped|2 target controls covered
27%
Open Banking Security
4 source controls mapped|4 target controls covered
27%
ISO/IEC 38500:2024 — Governance of IT
4 source controls mapped|4 target controls covered
27%
COSO Enterprise Risk Management (ERM) Framework (2017)
4 source controls mapped|5 target controls covered
27%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
4 source controls mapped|5 target controls covered
27%
EU Markets in Crypto-Assets Regulation (MiCA)
4 source controls mapped|7 target controls covered
27%
NIST SP 800-124 Rev 2 — Mobile Device Security
4 source controls mapped|4 target controls covered
27%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
4 source controls mapped|4 target controls covered
27%
MiFID II / MiFIR
4 source controls mapped|2 target controls covered
27%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
4 source controls mapped|5 target controls covered
27%
Serbia Law on Personal Data Protection (2018)
4 source controls mapped|5 target controls covered
27%
C5 (Germany)
4 source controls mapped|2 target controls covered
27%
BCBS 239
4 source controls mapped|4 target controls covered
27%
ISO 37000:2021 — Governance of Organizations
4 source controls mapped|4 target controls covered
27%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
4 source controls mapped|6 target controls covered
27%
EU Machinery Regulation (Regulation (EU) 2023/1230)
4 source controls mapped|5 target controls covered
27%
CSA STAR (Security, Trust, Assurance, and Risk)
4 source controls mapped|3 target controls covered
27%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
4 source controls mapped|4 target controls covered
27%
EU Network Code on Cybersecurity for the Electricity Sector
4 source controls mapped|4 target controls covered
27%
Laos Law on Prevention and Combating Cybercrime (2015)
4 source controls mapped|5 target controls covered
27%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
4 source controls mapped|3 target controls covered
27%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
4 source controls mapped|3 target controls covered
27%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
4 source controls mapped|6 target controls covered
27%
ISO 22320:2018
4 source controls mapped|4 target controls covered
27%
OSFI B-13
4 source controls mapped|4 target controls covered
27%
ISO 27017
4 source controls mapped|2 target controls covered
27%
OWASP DevSecOps Maturity Model (DSOMM)
4 source controls mapped|5 target controls covered
27%
ISO 26262:2018 — Functional Safety for Road Vehicles
4 source controls mapped|2 target controls covered
27%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
4 source controls mapped|3 target controls covered
27%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
4 source controls mapped|7 target controls covered
27%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
4 source controls mapped|4 target controls covered
27%
HIPAA Security Rule
4 source controls mapped|7 target controls covered
27%
ISO/IEC 27011:2024
4 source controls mapped|4 target controls covered
27%
APRA CPS 234
4 source controls mapped|4 target controls covered
27%
PCI PIN Security
4 source controls mapped|4 target controls covered
27%
HKMA SPM
4 source controls mapped|4 target controls covered
27%
BREEAM — Building Research Establishment Environmental Assessment Method
4 source controls mapped|2 target controls covered
27%
PCI SSF
4 source controls mapped|4 target controls covered
27%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|4 target controls covered
27%
EU Taxonomy Regulation
4 source controls mapped|4 target controls covered
27%
NIST SP 800-144
4 source controls mapped|2 target controls covered
27%
Azure Security Benchmark
4 source controls mapped|2 target controls covered
27%
21 CFR Part 211 — Current Good Manufacturing Practice
4 source controls mapped|2 target controls covered
27%
MTCS (Singapore)
4 source controls mapped|2 target controls covered
27%
NIST SP 800-190
4 source controls mapped|2 target controls covered
27%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|4 target controls covered
27%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|2 target controls covered
27%
MTCS — Multi-Tier Cloud Security (Singapore)
4 source controls mapped|3 target controls covered
27%
Digital Economy Partnership Agreement (DEPA)
4 source controls mapped|3 target controls covered
27%
CAIQ (CSA)
4 source controls mapped|2 target controls covered
27%
MAS TRM
4 source controls mapped|4 target controls covered
27%
PCI P2PE
4 source controls mapped|4 target controls covered
27%
NIST SP 800-145
4 source controls mapped|2 target controls covered
27%
ISMAP (Japan)
4 source controls mapped|2 target controls covered
27%
China Cybersecurity Law (CSL)
4 source controls mapped|2 target controls covered
27%
AWS Well-Architected Security Pillar
4 source controls mapped|2 target controls covered
27%
FFIEC IT Examination Handbook
4 source controls mapped|4 target controls covered
27%
GLBA
4 source controls mapped|4 target controls covered
27%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
27%
DORA
4 source controls mapped|4 target controls covered
27%
Colorado AI Act (SB 24-205)
4 source controls mapped|2 target controls covered
27%
SWIFT CSP
4 source controls mapped|4 target controls covered
27%
FTC GLBA Safeguards Rule (16 CFR Part 314)
4 source controls mapped|3 target controls covered
27%
ASIC Cyber Resilience Good Practices
4 source controls mapped|4 target controls covered
27%
AICPA SOC 1
4 source controls mapped|4 target controls covered
27%
French Sapin II Law (Law No. 2016-1691)
4 source controls mapped|2 target controls covered
27%
Philippines Cybercrime Prevention Act (RA 10175)
4 source controls mapped|2 target controls covered
27%
SWIFT CSCF
4 source controls mapped|4 target controls covered
27%
SOC 2
4 source controls mapped|3 target controls covered
27%
ECB TIBER-EU
4 source controls mapped|4 target controls covered
27%
AICPA SOC 3
4 source controls mapped|4 target controls covered
27%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
4 source controls mapped|2 target controls covered
27%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|4 target controls covered
20%
OWASP ASVS
3 source controls mapped|1 target controls covered
20%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
3 source controls mapped|3 target controls covered
20%
Brunei Personal Data Protection Order 2024 (PDPO)
3 source controls mapped|6 target controls covered
20%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
3 source controls mapped|5 target controls covered
20%
20%
Australia Online Safety Act 2021
3 source controls mapped|4 target controls covered
20%
APRA Prudential Standard CPS 234 — Information Security (Australia)
3 source controls mapped|1 target controls covered
20%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
20%
EDM Council CDMC — Cloud Data Management Capabilities Framework
3 source controls mapped|3 target controls covered
20%
NIST SP 800-128
3 source controls mapped|1 target controls covered
20%
ISO/IEC 25012:2008 — Data Quality Model
3 source controls mapped|2 target controls covered
20%
EN 50126/50128/50129 — Railway RAMS and Safety
3 source controls mapped|3 target controls covered
20%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
20%
EU AI Liability Directive
3 source controls mapped|4 target controls covered
20%
EU Web Accessibility Directive (Directive 2016/2102)
3 source controls mapped|3 target controls covered
20%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|3 target controls covered
20%
Chile Personal Data Protection Law (Law No. 21.719)
3 source controls mapped|3 target controls covered
20%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|4 target controls covered
20%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
20%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
3 source controls mapped|3 target controls covered
20%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|5 target controls covered
20%
RICS Professional Standards — Data and Technology in Property
3 source controls mapped|1 target controls covered
20%
NIST SP 800-160
3 source controls mapped|1 target controls covered
20%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
20%
20%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
20%
Science Based Targets initiative (SBTi) Corporate Standard
3 source controls mapped|2 target controls covered
20%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
20%
MITRE D3FEND
3 source controls mapped|1 target controls covered
20%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
20%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
20%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|5 target controls covered
20%
NIST SP 800-63
3 source controls mapped|1 target controls covered
20%
HITECH Act
3 source controls mapped|3 target controls covered
20%
20%
20%
Angola Personal Data Protection Law (Law No. 22/11)
3 source controls mapped|4 target controls covered
20%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
3 source controls mapped|3 target controls covered
20%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|4 target controls covered
20%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|4 target controls covered
20%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|5 target controls covered
20%
China Personal Information Protection Law (PIPL)
3 source controls mapped|3 target controls covered
20%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
20%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|2 target controls covered
20%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
3 source controls mapped|3 target controls covered
20%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 target controls covered
20%
20%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
3 source controls mapped|2 target controls covered
20%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
20%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
3 source controls mapped|3 target controls covered
20%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|5 target controls covered
20%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|4 target controls covered
20%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|4 target controls covered
20%
Botswana Data Protection Act (2024)
3 source controls mapped|5 target controls covered
20%
Fiji Data Protection Bill (2020)
3 source controls mapped|5 target controls covered
20%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|4 target controls covered
20%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|4 target controls covered
20%
ISO/IEC 30111:2019
3 source controls mapped|3 target controls covered
20%
ISO/IEC 29147:2018
3 source controls mapped|3 target controls covered
20%
Bermuda Personal Information Protection Act 2016 (PIPA)
3 source controls mapped|2 target controls covered
20%
ECSS Software Engineering Standards (ESA)
3 source controls mapped|3 target controls covered
20%
NIST SP 800-88
3 source controls mapped|1 target controls covered
20%
EU Cyber Resilience Act
3 source controls mapped|1 target controls covered
20%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
20%
20%
Online Safety Act 2021 (Australia)
3 source controls mapped|3 target controls covered
20%
21 CFR Part 58 — Good Laboratory Practice (GLP)
3 source controls mapped|2 target controls covered
20%
OpenSSF Scorecard
3 source controls mapped|1 target controls covered
20%
NIST SP 800-137
3 source controls mapped|1 target controls covered
20%
Armenia Law on Protection of Personal Data (2015)
3 source controls mapped|3 target controls covered
20%
ISO/IEC 29134:2023
3 source controls mapped|3 target controls covered
20%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
3 source controls mapped|3 target controls covered
20%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
20%
ISO/IEC 27400:2022
3 source controls mapped|3 target controls covered
20%
EU Data Act
3 source controls mapped|2 target controls covered
20%
MDS2 (Medical Device)
3 source controls mapped|3 target controls covered
20%
MITRE ATT&CK
3 source controls mapped|1 target controls covered
20%
NIST SP 800-207
3 source controls mapped|1 target controls covered
20%
South Korea PIPA
3 source controls mapped|1 target controls covered
20%
ISO/SAE 21434
3 source controls mapped|1 target controls covered
20%
PCI DSS v4.0
3 source controls mapped|3 target controls covered
20%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
20%
ISO 27043
3 source controls mapped|1 target controls covered
20%
COBIT 2019
3 source controls mapped|1 target controls covered
20%
South Korea Credit Information Act
3 source controls mapped|1 target controls covered
20%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
20%
OWASP MASVS
3 source controls mapped|1 target controls covered
20%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
20%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
20%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
3 source controls mapped|3 target controls covered
20%
NIST SP 800-61
3 source controls mapped|1 target controls covered
20%
NIST SP 800-115
3 source controls mapped|1 target controls covered
20%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
20%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
20%
NIST SP 800-161
3 source controls mapped|1 target controls covered
20%
California IoT Security Law
3 source controls mapped|1 target controls covered
20%
3GPP 5G Security Architecture (TS 33.501)
3 source controls mapped|2 target controls covered
20%
PTES
3 source controls mapped|1 target controls covered
20%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
20%
3GPP Security
3 source controls mapped|1 target controls covered
20%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
20%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
20%
NIST SP 800-183
3 source controls mapped|1 target controls covered
20%
NIST SP 800-181
3 source controls mapped|1 target controls covered
20%
NIST SP 800-218
3 source controls mapped|1 target controls covered
20%
IEC 62351 — Power Systems Communication Security
3 source controls mapped|1 target controls covered
20%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
20%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
20%
NIST SP 800-187
3 source controls mapped|1 target controls covered
20%
HL7 FHIR Security Framework
3 source controls mapped|1 target controls covered
20%
NIST SP 800-92
3 source controls mapped|1 target controls covered
20%
NIST SP 800-123
3 source controls mapped|1 target controls covered
20%
ASIS SPC.1-2009 — Organizational Resilience Standard
3 source controls mapped|1 target controls covered
20%
BSIMM
3 source controls mapped|1 target controls covered
20%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
20%
ETSI EN 303 645
3 source controls mapped|1 target controls covered
20%
NIST SP 800-150
3 source controls mapped|1 target controls covered
20%
ISO 27002:2022
3 source controls mapped|1 target controls covered
20%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
3 source controls mapped|3 target controls covered
20%
SWIFT Customer Security Programme (CSP)
3 source controls mapped|2 target controls covered
20%
20%
US OFAC Sanctions Compliance Framework
3 source controls mapped|1 target controls covered
20%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|1 target controls covered
20%
WCAG 2.2
3 source controls mapped|1 target controls covered
20%
UNECE WP.29 R155
3 source controls mapped|1 target controls covered
20%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
3 source controls mapped|2 target controls covered
20%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|4 target controls covered
20%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|4 target controls covered
20%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|4 target controls covered
20%
Jamaica Data Protection Act 2020
3 source controls mapped|3 target controls covered
20%
Mauritius Data Protection Act 2017
3 source controls mapped|2 target controls covered
20%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
20%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|2 target controls covered
20%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
3 source controls mapped|3 target controls covered
20%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|4 target controls covered
20%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
3 source controls mapped|4 target controls covered
20%
UK Building Safety Act 2022
3 source controls mapped|2 target controls covered
20%
SLSA
3 source controls mapped|1 target controls covered
20%
Washington My Health My Data Act (MHMD)
3 source controls mapped|1 target controls covered
20%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
3 source controls mapped|1 target controls covered
20%
SSDF (NIST)
3 source controls mapped|1 target controls covered
20%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
3 source controls mapped|3 target controls covered
20%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
3 source controls mapped|3 target controls covered
20%
OWASP SAMM
3 source controls mapped|1 target controls covered
20%
UNECE WP.29 R156
3 source controls mapped|1 target controls covered
20%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
20%
Singapore Cybersecurity Act 2018
3 source controls mapped|1 target controls covered
20%
Cyber Security Act 2024 (Australia)
3 source controls mapped|1 target controls covered
20%
Virginia Consumer Data Protection Act (VCDPA)
3 source controls mapped|1 target controls covered
20%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|1 target controls covered
20%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
20%
UK PSTI Act
3 source controls mapped|1 target controls covered
20%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
20%
SIG (Shared Assessments)
3 source controls mapped|1 target controls covered
20%
NIS2 Directive
3 source controls mapped|4 target controls covered
20%
CSA CCM v4
3 source controls mapped|8 target controls covered
20%
C2M2
3 source controls mapped|3 target controls covered
20%
NIST SP 1800-32
3 source controls mapped|3 target controls covered
20%
NIST SP 800-53 Rev 5
3 source controls mapped|4 target controls covered
20%
IEEE 1686
3 source controls mapped|3 target controls covered
20%
BIMCO Cyber Security
3 source controls mapped|3 target controls covered
20%
IEC 62443
3 source controls mapped|3 target controls covered
20%
NIST Privacy Framework 1.0
3 source controls mapped|5 target controls covered
20%
ISO 27019
3 source controls mapped|4 target controls covered
20%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|9 target controls covered
20%
DO-326A
3 source controls mapped|3 target controls covered
20%
API 1164
3 source controls mapped|3 target controls covered
20%
NERC CIP
3 source controls mapped|4 target controls covered
20%
TSA Pipeline Security
3 source controls mapped|3 target controls covered
20%
SASB Standards (ISSB Integrated)
3 source controls mapped|5 target controls covered
20%
SASB Standards
3 source controls mapped|5 target controls covered
20%
ISO 31000
2 source controls mapped|4 target controls covered
13%
ISO 9001
2 source controls mapped|4 target controls covered
13%
ISO 27005
2 source controls mapped|4 target controls covered
13%
ISO 37001
2 source controls mapped|2 target controls covered
13%
NIST SP 800-37
2 source controls mapped|4 target controls covered
13%
ISO 37301
2 source controls mapped|2 target controls covered
13%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
2 source controls mapped|2 target controls covered
13%
ISO 19011
2 source controls mapped|2 target controls covered
13%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|4 target controls covered
13%
NIST SP 800-39
2 source controls mapped|4 target controls covered
13%
ISO 55001
2 source controls mapped|2 target controls covered
13%
ISO 30401
2 source controls mapped|2 target controls covered
13%
COSO ERM
2 source controls mapped|4 target controls covered
13%
NIST SP 800-30
2 source controls mapped|4 target controls covered
13%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|2 target controls covered
13%
SA8000:2014 — Social Accountability Standard
2 source controls mapped|2 target controls covered
13%
ISO 27001:2022
2 source controls mapped|4 target controls covered
13%
Oman National Cybersecurity Framework
2 source controls mapped|4 target controls covered
13%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
2 source controls mapped|4 target controls covered
13%
WCO Authorised Economic Operator (AEO) Framework
2 source controls mapped|8 target controls covered
13%
Authorised Economic Operator (AEO) Programmes — Global Standards
2 source controls mapped|4 target controls covered
13%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
2 source controls mapped|3 target controls covered
13%
APRA CPS 230 Operational Risk Management
2 source controls mapped|5 target controls covered
13%
13%
13%
Customs-Trade Partnership Against Terrorism (C-TPAT)
2 source controls mapped|5 target controls covered
13%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
2 source controls mapped|5 target controls covered
13%
EU Chips Act (Regulation (EU) 2023/1781)
2 source controls mapped|5 target controls covered
13%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|5 target controls covered
13%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|3 target controls covered
13%
Solvency II
2 source controls mapped|4 target controls covered
13%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
7%
ISO 45001
1 source controls mapped|1 target controls covered
7%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
7%
EU Better Internet for Kids (BIK+) Strategy
1 source controls mapped|1 target controls covered
7%
ISO 22000
1 source controls mapped|1 target controls covered
7%
ISO 20000-1
1 source controls mapped|1 target controls covered
7%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
7%
NIST SP 800-172
1 source controls mapped|1 target controls covered
7%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
7%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
7%
FISMA
1 source controls mapped|1 target controls covered
7%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|1 target controls covered
7%
CMMC 2.0
1 source controls mapped|1 target controls covered
7%
ITIL 4
1 source controls mapped|1 target controls covered
7%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
7%
NIST SP 800-171
1 source controls mapped|1 target controls covered
7%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
7%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
7%
Spain ENS
1 source controls mapped|1 target controls covered
7%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|1 target controls covered
7%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
7%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
7%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
7%
C-TPAT — Customs-Trade Partnership Against Terrorism
1 source controls mapped|3 target controls covered
7%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
1 source controls mapped|2 target controls covered
7%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
7%
ISO 22316
1 source controls mapped|1 target controls covered
7%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
7%
CDP Corporate Questionnaire
1 source controls mapped|1 target controls covered
7%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
7%
ISO 22318
1 source controls mapped|1 target controls covered
7%
ISO 22301
1 source controls mapped|1 target controls covered
7%
ISO 26000:2010
1 source controls mapped|1 target controls covered
7%
ISO 22317
1 source controls mapped|1 target controls covered
7%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
7%
Space ISAC (Information Sharing and Analysis Center) — Threat Framework
1 source controls mapped|1 target controls covered
7%
Defence Industry Security Program (DISP)
1 source controls mapped|1 target controls covered
7%
US Executive Order 14028 — Improving the Nation's Cybersecurity
1 source controls mapped|2 target controls covered
7%
Sigstore — Software Artifact Signing and Verification
1 source controls mapped|1 target controls covered
7%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
1 source controls mapped|1 target controls covered
7%
Australia AI Ethics Framework
1 source controls mapped|3 target controls covered
7%
OECD AI Principles
1 source controls mapped|3 target controls covered
7%
ISO 42001
1 source controls mapped|3 target controls covered
7%
Singapore Model AI Governance Framework (2nd Edition)
1 source controls mapped|1 target controls covered
7%
China AI Regulations
1 source controls mapped|3 target controls covered
7%
NIST Privacy Framework Version 1.0
1 source controls mapped|2 target controls covered
7%
Brazil AI Framework
1 source controls mapped|3 target controls covered
7%
APRA CPS 220 Risk Management
1 source controls mapped|3 target controls covered
7%
EU AI Act
1 source controls mapped|3 target controls covered
7%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
1 source controls mapped|1 target controls covered
7%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
7%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|1 target controls covered
7%
IEEE 7000
1 source controls mapped|3 target controls covered
7%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|2 target controls covered
7%
Global Cross-Border Privacy Rules (Global CBPR) Forum
1 source controls mapped|1 target controls covered
7%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
1 source controls mapped|2 target controls covered
7%
Canada Artificial Intelligence and Data Act (AIDA)
1 source controls mapped|1 target controls covered
7%
Japan AI Guidelines
1 source controls mapped|3 target controls covered
7%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
7%
OECD AI Principles (2024 Update)
1 source controls mapped|1 target controls covered
7%
ICMM Mining Principles (2024 Update)
1 source controls mapped|1 target controls covered
7%
Singapore AI Governance Framework
1 source controls mapped|3 target controls covered
7%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|3 target controls covered
7%
UK AI Regulation Framework
1 source controls mapped|3 target controls covered
7%
SEC Cybersecurity Disclosure Rules
1 source controls mapped|2 target controls covered
7%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
7%

Frequently Asked Questions

What is ICH Q10 — Pharmaceutical Quality System?

ICH Q10 — Pharmaceutical Quality System is a compliance framework from International (ICH) with 3 domains and 15 controls. ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system (PQS) based on ISO quality concepts, applicable GMP regulations, and ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). It establishes a system for lifecycle management of pharmaceutical products covering development, technology transfer, commercial manufacturing, and product discontinuation. Adopted by FDA, EMA, and PMDA. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does ICH Q10 — Pharmaceutical Quality System have?

ICH Q10 — Pharmaceutical Quality System has 15 controls organised across 3 domains. The largest domains are Section 2 - Management Responsibility (7 controls), Section 1 - Pharmaceutical Quality System (4 controls), Section 3 - Continual Improvement of Process Performance and Product Quality (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does ICH Q10 — Pharmaceutical Quality System map to?

ICH Q10 — Pharmaceutical Quality System maps to 525 other compliance frameworks. The top mapping partners are PIC/S Guide to Good Manufacturing Practice for Medicinal Products (53% coverage), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (53% coverage), BS 65000:2014 — Guidance on Organizational Resilience (53% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with ICH Q10 — Pharmaceutical Quality System compliance?

Start your ICH Q10 — Pharmaceutical Quality System compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ICH Q10 — Pharmaceutical Quality System 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 15 controls and track your progress.

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