The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and manufacturing environments. The revised guideline should clarify requirements and expectations from regulatory authorities, and remove ambiguity and inconsistencies
In 2011, EudraLex The Rules Governing Medicinal Products in the European Union published Annex 11: Computerised Systems as part of Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary. 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 that together fulfill certain functionalities.
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems, be revised to reflect changes in regulatory and manufacturing environments. The revised guideline would clarify requirements and expectations from regulatory authorities and remove ambiguity and inconsistencies.
The updated Annex 11 outlines the requirements for the use of computerised systems in GMP-regulated activities, thereby ensuring product quality, patient safety, and data integrity.
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