Good Manufacturing Practice Human and Veterinary Medicinal Products
Annex 11: Computerized systems
Principle
"This Annex applies to all types of computerized systems used in a GMP-regulated activity. A computerized system is a set of software and hardware components that together perform specific functions.
The application should be validated; the IT infrastructure should be qualified. If a computerized system replaces a manual process, it should not result in a degradation of product quality, process control, or quality assurance. The overall risk of the process should not increase."
Uson test equipment is ready for the implementation of the EU directives and Uson provides the necessary documents for the qualification of the test equipment (IQ, OQ and PQ).
Uson provides two solutions that allow EU compliant implementation of the directives. For the local variant, integration into the company's own IT infrastructure is not necessary. For the network-based solution, technical and security-relevant aspects must be taken into account at the interface between the test device and the company network.
The role of IT
For the creation of the URS, it is recommended not only to involve the own IT in the creation process, but to consider it like a supplier in order to emphasize the responsibility for the integration, maintenance and care of the future test system into the IT infrastructure.
IT's tasks are to:
Setup must comply with corporate cyber security policies. IT must initiate the associated internal approval process for the new test device and be able to answer open questions.