Computerized systems should be validated in accordance with quality risk management
principles and the level of validation should be commensurate to identified risks, complexity and
intended use. This guide applies to systems used in GMP (4) but may be extended to
systems used in all good practice (GxP) activities, as appropriate.
2.2 The purpose of validation is to confirm that the computerized system specifications
conform to the user’s needs and intended use by examination and provision of documented and
objective evidence that the particular requirements can be consistently fulfilled. Validation
should establish confidence in the accuracy, reliability and consistency in the performance of the system, and it should also ensure that all necessary technical and procedural controls are
implemented confirming compliance with good documentation practices for electronic data
generated by the system (5).
2.3 System elements that need to be considered in computerized system validation include
computer hardware and software, related equipment and IT infrastructure and operating system…
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