EU referenties:

• Eudralex volume 4 Good Manufacturing Practice (GMP): Medicinal Products for Human and Veterinary Use
• EU Annex 11: EudraLex, Volume 4, GMP Annex 11: Computerised Systems
• EMA Questions & Answers: Good manufacturing practice, Data Integrity

UK & MHRA referenties:

• MHRA ‘GXP’ Data Integrity Guidance and Definitions, March 2018

US referenties:

• US 21 CFR Part 210, 211, 11 
• US Food and Drug Administration, Guidance for Industry, Data Integrity and Compliance in CGMP, December 2018

Algemene referenties:

• ISPE - International Society for Pharmaceutical Engineering
• WHO - Guideline Good Data and Record Management Practices (June 2016)