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:
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: