European Union GMP Requirements for Computerised Systems

This course introduces the European Union’s GMP requirements for computerised systems that are associated with the manufacture of medicinal products. Reference is also made to FDA expectations. This course covers requirements that govern the use of computerised systems as specified in regulations and guidance documents issued by the European Union.

After this course learners will be able to identify the requirements and definitions associated with the european union’s gmp regulations for computerised systems. recognise the requirements for the implementation of computerised systems, and for post implementation monitoring. recognise the measures taken to maintain data accuracy and security when using computerised systems. identify required control and security measures as well as the responsibilities management have for computerised systems.