Appropriate operator qualifications are vital prerequisites for GMP-compliant production.
Such appropriate qualifications are legally required for specific tasks in pharmaceutical
production and according qualification evidence is to be provided. PAS-X provides the
OPERATOR TRAINING RECORDS business function to ensure that only adequately trained employees
gain access to electronic execution operations.
The system checks the operator's qualification level during the login process.
If applicable, the operator is advised of GMP-relevant qualifications which are
missing or which have expired. At the same time, the supervisor will also receive this information.
OPERATOR TRAINING RECORDS enables the person in charge of GMP
training to administer training courses and their content, as well as to
maintain user profiles. The software gives a summary of the qualifications
of each individual employee.
Furthermore, the software provides information and functions which can be used to evaluate employees'
levels of knowledge and the contents of training courses. OPERATOR TRAINING RECORDS
acquires and monitors also automated, computer-based training and supports the planning and post-processing
of training courses.