BITC CSV packet⁷

DI Dr. Rainer Blöchl

The BITC CSV packet⁷ is a flexible tool with a modular structure used to support the validation of computerised systems (CS) in regulated areas (Pharma, Life Science, Medical Products, Health Care). It is based on a standardised, modular and risk-based validation approach, which can be adapted to specific customer requirements quickly and without complications.

By using templates and best practice, which are available for a number of application areas, CS validation can be realised quickly, efficiently and affordably.

The BITC CSV packet⁷ offers companies for which the validation of computerised systems is "virgin soil" the opportunity to already implement the SOPs required for a validation in accordance with GxP even during the design phase. This allows them to ensure that the validation requirements can already be taken into account when defining user requirements, when choosing a system and selecting suppliers.

The BITC-CSV packet⁷ can be particularly invaluable when realising IT systems, which require validation, in cooperation with external system suppliers. If validation requirements are defined early, they can already be suitably taken into account during the quote and contract stages. This means that expensive and time-consuming interface problems and rectifications can be avoided.

The integral validation approach on which the BITC CSV packet⁷ is based takes account of all elements required for a validation according to GxP. As a result, the completeness and integrity of the system validation can be ensured for each use case. This means regulatory security and sustainable safeguarding of the investments linked to the validation.

However, the value of the BITC CSV packet⁷ is based on more than just regulatory compliance. The consistent application of the underlying SDLC process and the focus on well-structured, consistent and complete system specifications can significantly contribute to ensuring the success of system development and implementation.