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Solutions
Digital Transformation
IT Strategy
Data Management
IT Compliance
Computerized System Validation
IT Infrastructure
Contact us
Contact us
Join Akility
Book a meeting
About us
Digital Transformation
IT Strategy
Data Management
IT Compliance
Computerized System Validation
IT Infrastructure
Book a meeting
Contact us
Join Akility
About us
Menu
Digital Transformation
IT Strategy
Data Management
IT Compliance
Computerized System Validation
IT Infrastructure
Book a meeting
Contact us
Join Akility
About us
Book a meeting
Regulations & Guidelines
ISPE - GAMP® 5 (Good Automated Manufacturing Practice) guidance
GAMP® 5 : A Risk-Based Approach to Compliant GxP Computerized Systems – ISPE 2008
GAMP® 5 : Quality Risk Management Approach
IT Infrastructure Control and Compliance – ISPE 2017
Considerations for a Corporate Data Integrity Program – ISPE 2017
GAMP® Guide: Records & Data Integrity – ISPE 2017
Eudralex / EU Regulation
EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
EudraLex – Volume 4 – Annex 11 – Computerised Systems
EudraLex – Volume 4 – Annex 15 – Qualification and Validation
EudraLex – Volume 4 – Chapter 7 – Outsourced Activities
EudraLex – Volume 4 – Glossary
Good Distribution Practice (GDP) of medicinal products for human use
Good Distribution Practice (GDP) for active substances for medicinal products for human use
Questions and Answers on GDP
Directive 2011/62/EU (English) – Falsified Medicines Directive (FMD)
Commission delegated regulation (EU) 2016/161 of 2 October 2015 (English)
EMA (European Medicine Agency) references
ICH guideline Q9 on quality risk management
EMA GMP Data Integrity Guidance – August 2016
European Medicines Agency (EMA) Master Data Management Roadmap – April 2015
FDA (US Food & Drug Administration) Regulation
21 CFR Part 11 (eCFR) – Electronic Records; Electronic Signatures
21 CFR Part 11 – Electronic Records; Electronic Signatures — Scope and Application
21 CFR Part 210 (eCFR) – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 211 (eCFR) – Current Good Manufacturing Practice for Finished Pharmaceuticals
Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry – December 2018
Current expectations and Guidance, including Data Integrity and Compliance with cGMP – June 2016
Microsoft GxP references
Microsoft Azure GxP Guidelines
(April 2018)
Medical devices - Quality management systems
ISO 13485:2016
MHRA (Medicines & Healthcare products Regulatory Agency) Regulation
MHRA GxP Data Integrity Guidance and Definitions – March 2018
MHRA GxP Data Integrity Definitions and Guidance for Industry – Draft version for consultation July 2016
PIC/S (Pharmaceutical Inspection Co-operation Scheme) references
PIC/S PI 041-1 – Good practices for computerized systems in regulated GxP environments – 1 July 2021
USP (US Pharmacopeia) references
Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification
WHO (World Health Organisation) references
Guidance on good data and record management practices
Guideline on data integrity – Annex 4
PDA Journal (Parenteral Drug Association) references
Data Integrity—A Study of Current Regulatory Thinking and Action – 2015
Data Integrity Case Studies – March 2017
IVT Network (Institute of Validation Technology) references
Audit Trails Reviews for Data Integrity – Oct. 2015
Data Integrity Strategies for Quality Control Laboratories – March 2017
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pdf version
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