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Regulations and Guidelines

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

Date           Guidance or Regulation


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


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