European Commission
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Eudralex V4 Annex 16: Certification by a Qualified Person and Batch Release, 10/15
EudraLex Volume 4, Annex 16 specifically allows for the use of validated computerized systems as safeguards to ensure that uncertified batches are not sold.
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Eudralex V4 Annex 15: GMP Guidelines for Qualification and Validation, 3/15
EudraLex Volume 4, Annex 15 now refers users to Annex 11, Computerised Systems, for the specific details regarding validation of computer systems.
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EC Guidelines on Good Distribution Practice for Active Substances, 3/15
In March, 2015 the EU Commission published GDP Guidelines for APIs. Details for electronic records, systems, and signatures are found throughout.
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EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use 2013 v2, 11/13
In November, 2013 the EU Commission published Guidelines on Good Distribution Practice of Medicinal Products for Human Use. This replaces the March ’13 GDP directive.
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EC Proposed General Data Protection Regulation, 1/12
In January, 2012 the EC proposed this regulation. This regulation will impact several areas, including adverse event reporting and clinical trial data management.
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EC Medical Device Guidance: Qualification and Classification of Stand Alone Software, 1/12
In January 2012, the EC published this guidance to define the criteria for the qualification of stand alone software, when used in a healthcare setting as a medical device.
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Eudralex V4 Chapter 4: Documentation, 1/11
This version of Volume 4, Chapter 4, Documentation, was published in January 2011 to correspond with changes in EU GMP Annex 11, Computerised Systems.ﾠ
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Eudralex V4 Annex 11: Computerised Systems, 1/11
This version of Annex 11, Computerised Systems, was published by the EC in January 2011 to address the increased use and complexity of computerised systems.
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EC Council Directives related to In Vitro Medical Devices, 8/09
The cumulative directives of the European Parliament and Council from October 1998 through August, 2009 regarding in vitro diagnostic medical devices.
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Eudralex V10 Ch IV: Guidelines for the Conduct of GCP Inspections, 5/08
This document provides a framework for conducting Good Clinical Practice (GCP) inspections. Annex III provides additional guidance for computer system inspections.
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Eudralex V10 Ch IV Annex III: Guidelines for the Conduct of GCP Inspections – Computerised Systems, 5/08
This guide for GCP inspections refers readers to the PIC/S document “Guidance on Good Practices for Computerised Systems in Regulated ‘GXP’ Environments”, PI-011-3.
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Eudralex V4 Annex 20: GMP Guidelines for Quality Risk Management, 2/08
This annex to Volume 4 outlines a program of quality risk management. See section II.4 for potential application for computer systems.
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EC Council Directives related to Medical Devices, 10/07
The cumulative directives of the European Parliament and Council from June 1993 through November 2007 regarding medical devices.
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EC Council Directives related to Active Implantable Medical Devices, 10/07
The cumulative directives of the European Parliament and Council from June 1990 through October 2007 regarding active implantable medical devices.
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Eudralex V4 Annex 18: GMP Guidelines for Active Pharmaceutical Ingredients, 7/01
GMP for API manufacturers. See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.
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