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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21/7/2016 Draft Guidance (consultation)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May 2016 Draft Guidance WHO Guidelines on Validation - Appendix 5 Validation of Computerised Validation Click here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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