Regulations and Guidelines

Please see the table below with links to various guidance and regulation information.

Date	Guidance or Regulation	Source	Article Title	Link
01/04/2020	Notice	EMA	Notice to sponsors on validation and qualification of computerised systems used in clinical trials	Click here
01/12/2018	Data Integrity Guidance	FDA	Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry	Click here
01/03/2018	Data Integrity Guidance	MHRA	‘GXP’ Data Integrity Guidance and Definitions March	Click here
01/06/2017	GCP Guidance	FDA	Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11	Click here
01/10/2019	Data Integrity Guidance	WHO	Guideline on Data Integrity	Click here
01/04/2016	GLP Guideline	OECD	Application of GLP Principles to Computerised Systems	Click here
01/06/2011	GMP Guideline	EC	Annex 11: Computerised Systems	Click here
01/09/2007	GxP Guidance	PIC/S	Good Practices for Computerised Systems in Regukated 'GxP' Environments	Click here