Validating computer systems

validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes Computers are widely used during development and manufacturing of drugs and medical devices.

Proper functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data.

Therefore, computer system validation (CSV) should be part of any good development and manufacturing practice.

It is also requested by FDA regulations and guidelines through the overall requirement that "equipment must be suitable for it's intended use".

It has more than 50 pages and includes a six page checklist recommended to be used by for inspectors.In this document the FDA promoted the concept of risk based validation .By far the most detailed and most specific official document that has ever been developed on using computers in regulated areas is the “Good Practices Guide on Using Computers in Gx P Environments.” (6).For an existing system it starts when the system owner gets the task of bringing the system into a validated state.Validation ends when the system is retired and all-important quality data is successfully migrated to the new system.

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