US FDA 21 CFR Part 211, Current Good Manufacturing Practice for finished Pharmaceuticals 2019
US FDA 21 CFR Part 210 PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
US FDA 21 CFR Part 11, Electronic Records; electronic signatures
US FDA Guidance for Industry 21 CFR Part 11, Electronic Records; Electronic Signatures - Scope and Application
ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition, 2022
EU GMP Guide Annex 11, "Computer-aided systems"
EU GMP Guide Annex 15, "Qualification and Validation"
Medicinal Products and Active Substances Manufacturing Ordinance (AMWHV)
FDA Guidance on Computer Software Assurance for Production and Quality System Software
ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance, Second Edition
ISPE GAMP Good Practice Guide: Data Integrity – Manufacturing Records, 2019
ISPE GAMP Records and Data Integrity Guide, 2017
ISPE GAMP Good Practice Guide: Risk-Based Approach to Compliant Electronic Records and Signatures, February 2005
ISPE GAMP Good Practice Guide: Records and Data Integrity, 2017
ISPE Commissioning and Qualification Baseline Guide Volume 5, 2nd Edition
ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition). February 2017
ICH Q9, Quality Risk Management, 2023
Computer Software Assurance for Production and Quality System Software, Draft, September 2022, www.fda.gov.