Regulations and Guidelines

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

Date	Guidance or Regulation	Source	Article Title	Link
21/7/2016	Draft Guidance (consultation)	MHRA	MHRA GxP Data Integrity Definitions and Guidance for Industry	Click here
May 2016	Draft Guidance	WHO	Guidelines on Validation - Appendix 5 Validation of Computerised Validation	Click here
22/4/2016	Guidance	OECD	OECD Guideline - The Application of the Principles of GLP to Computerised Systems	Click here
April 2016	Guidance	FDA	Data Integrity and Compliance with CGMP	Click here
15/4/2016	Guidance	FDA	BIMO Attachment A: Computerized Systems	Click here
March 2015	Guidance	MHRA	GMP Data Integrity Definitions and Guidance for Industry	Click here
8/8/2014	Guidance	MHRA	Medical Devices: Software applications (apps)	Click here
25/11/2014	Guidance	FDA	FDA Inspection Guide, Management Controls Subsystem	Click here
8/4/2013	Guidance	ABPI	Guidance notes on the management of adverse events and product complaints from digital media	Click here
1/12/2012	Guidance	AGIT	Guidelines for the Change Management and Risk Assessment of Validated computerised systems in a GLP environment	Click here
1/9/2013	Guidance	FDA	Electronic Source Documentation in Clinical Investigations	Click here
1/8/2012	Guidance	AGIT	Spreadsheets	Click here
3/8/2011	Guidance	AGIT	Guidelines for the Development and Validation of Spreadsheets	Click here
1/10/2011	Guidance	EudraLex	Volume 9B - Pharmacovigilance for Medicinal Products for Veterinary Use	Click here
30/6/2011	Guidance	EudraLex	Annex 11: Computerised Systems	Click here
14/12/2007	Guidance	AGIT	Computerised Systems Validation	Click here
28/11/2007	Procedure	INS-GCP-3	Annex 111 to Procedure for conducting GCP inspection requested by the EMEA - Computerised Systems	Click here
25/9/2007	Guidance	PIC/S	Good Practices for Computerised Systems in Regulated GxP Environments (P1 011-3)	Click here
11/6/2007	Guidance	OECD	Establishment and Control of Archives that Operate in Compliance with the Principles of GLP	Click here
1/5/2007	Guidance	FDA	Computerized Systems Used in Clinical Investigations	Click here
20/11/2006	Guidance	CDISC	Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials	Click here
1/3/2006	Guidance	GLPMA	Guidance on Archiving	Click here
1/12/2005	Guidance	AGIT	Electronic Raw Data	Click here
August 2003	Guidance	FDA	21 CFR Part 11 Electronic Records; Electronic Signatures - Scope and application	Click here
9/6/2003	Guidance	AGIT	Guidelines for the Archiving of Electronic Raw Data	Click here
24/7/2001	Guidance	AGIT	Electronic Standard Operating Procedure (SOP) Management	Click here
August 1997	Regulation	FDA	21 CFR Part 11 Electronic Records; Electronic Signatures	Click here
24/10/1995	Guidance	EU	Directive 95/46/EC of the European Parliament and of the council	Click here
1995	Consensus	OECD	The Application of the Principles of GLP to Computerised Systems	Click here

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Regulations and Guidelines

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