17/18 May 2021
GMP News No. 869
EMEA Publishes Concept Paper on Annex 11 - Computerised Systems
The basic content of Annex 11 can certainly be applied to many IT areas still today. However, both inspectors and the industry have more and more difficulties in assessing new technological developments with the help of this regulation.
For this reason, the EMEA suggests establishing an Ad Hoc GMP Services Group whose task it will be to update/revise Annex 11. In addition, Chapter 4 "Documentation" of the EC-GMP Guide is meant to be reviewed at the same time. Whereas up to now, Chapter 4 focussed on "paper documentation", in the future it should also deal in detail with "electronic documentation", not least in view of the revision of Annex 11.
The following schedule is planned for the revision of the two
In the following we have listed some of the questions that should be addressed by the Ad Hoc Group during the revision of Annex 11:
This Services Group should consist of 3-5 experts from different
countries. According to the author of this news, it would not come as a
surprise if the members of the Ad Hoc Group were identical with the
PIC/S Expert Circle on Computerised Systems, nor would it be a bad thing
since the PIC/S document PI 011-2 "Good Practices for Computerised
Systems in Regulated "GxP" Environments" represents the regulatory state
of the art.
The following ECA events focus on specific aspects of computerised systems:
Paper on the revision of Annex 11 and Chapter 4 can be downloaded here -
the deadline for comments is 31 March 2007: