GLP

UK GLP Regulations

OECD Guidance on GLP Archives

EMEA Guidance for laboratories that perform analysis or evaluation of clinical trial samples (so called “GCLP”)

Note: the MHRA Guidances on GLP Archiving and GCLP that were formerly linked from this page have now been withdrawn.  Use the OECD/EMEA Guidance documents instead.

GMP

EudraLex – Volume 4: Good manufacturing practice (GMP) Guidelines – Chapter 4: Documentation

ICH Quality Guideline Q7: GMP Guidance for Active Pharmaceutical Ingredients
(refer to section 6)

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

GCP

EU Directive 2001/20 (Clinical Trials Directive) and Regulation 536/2014 (“New” Clinical Trials Regulation)

EU Directive 2005/28 (Good Clinical Practice)

Trial Master File Reference Model

Electronic records

FDA part 11 guidance for electronic records

International Research on Permanent Authentic Records in Electronic Systems

Model Requirements Specification for the Management of Electronic Records

Other associations

Information and Records Management Society (IRMS)

The Research Quality Association

Archives and Records Association

Health Archives and Records Group (HARG)