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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 |
| 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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