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Annexe 11 - Computerized Systems

A revision of the Annex 11 to the European GMP has been released on 2011-01-12. A French version of this document is available on this web site for information only. Even if the document has been carefully and accurately reviewed, it cannot replace an official version which could be later published by a French speaking regulatory Agancy.

By updating the national GMP, the French authorities released on 2013-12-04 a French version of Annex 11.

On 2012-10-01, the revised Annex 11 and Chapter 4 have been adopted by the PIC/S participating authorities, valid as of 2013-01-01.

Supporting documents

Votum 11003 (Germany)

The expert circle EFG 11 of the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) released the Votum 11003 regarding the requirements related to electronic and handwritten signatures.

This votum impacts only healthcare organisations based in Germany. However, since some organisations based in the French speaking area could have to deal - directly or indirectly - with these mentioned requirements, a French version of this document has been elaborated for information purpose only additionally to the original German text.

On 2010-12-22, this Votum has been revised and published in order to reflect the new version of the Annex 11.

Articles

Several articles about the revised Annex 11 have been written by Yves Samson during 2011:

Cross walk "Annex 11 - US FDA 211, 820, 11 - other guidelines"

In February 2011, Orlando López published a first version of a "cross walk" document providing a detailled analysis of the new Annex 11 against other regulations and standards, such as:

  • 21 CFR 11
  • 21 CFR 211
  • 21 CFR 820
  • PIC/S PI 011
  • ICH Q7
  • 21 CFR 58
  • ISO 14971
  • GAMP® 5
  • etc.

as well as against the first version of Annex 11 (1992).

Since then, Orlando updates regularly this regulatory analysis.

Orlando Lopez - computer-systems-validation.net - is a well recognized expert within the pharmaceutical industry and an active member of the GAMP® Community.

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Last update: 2017-01-01

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