GxP validation of computerised systems
The validation of computer-based systems (CS) required documented evidence that these systems function correctly and in accordance with predefined specifications. This constitutes a difficult hurdle for many companies regarding compliance with the health-authority regulations (GxP).
The reasons for this is the high complexity of modern systems as well as the fact that the responsibility for the application and infrastructure is typically split between the technical departments and IT. This calls for a special validation approach and sound cross-functional experience for the practical implementation.
As a result, companies are increasingly trying to outsource CS validations to software and system suppliers. There, however, specific GxP CS validation know-how tends to be restricted. This often leads to sub-standard validations with a high regulatory risk as these are limited to only the functional aspects of the application.
In this context, BITC supports both GxP regulated companies and software and system suppliers as a reliable partner for the validation of computer-based systems, both according to EMA and FDA standards. Based on our many years of practical experience in international pharmaceutical companies, we can offer you support for the validation and qualification of computer-based systems in all phases of the System Development Life Cycle (SDLC) process.
We apply a risk-based approach, which ensures that your investments in the validation of computer-based systems can be used optimally and sustainably.
BITC also offers a standardised GxP IT compliance packet to companies, which currently implement or operate GxP-relevant, computer-based systems but which do not have a relevant defined CS validation process or adequate quality management system (QMS).
Das BITC GxP IT compliance packet is based on practical experience and Best Practice and is a simple, robust system enabling a seamless integration with other IT management systems (e.g. ITIL, SOX IT, COBIT, ISEC etc.) using the BITC P-CRQ .
The template-oriented approach means that the BITC GxP IT compliance packet allows for a fast and affordable realisation, which was previously impossible, of the IT QMS required for validation and the determination of the validation process.
