EMA published today the new GMP Annex 11 – Computerised Systems – revision January 2011 – download your copy here: PDF
The deadline for coming into operation of the new Annex 11 is 30th June 2011.
- Find here also the new EudraLex Chapter 4 – Documentation: PDF
- Report “New Annex 11” in German from the GMP Verlag: Info
Basic Principle of the new Annex 11 (Ref.: annex11_01-2011_en):
This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.
The application should be validated; IT infrastructure should be qualified.
Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
Contact now CCS for the new Annex 11 implementation package for efficient and compliant integration: email@example.com