Continued process verification (CPV) and the validation of informatics systems

Continued process verification (CPV) is an activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by the FDA in 2011 emphasized the importance of manufacturers engaging in CPV as an integral part of their process validation lifecycle. CPV provides the manufacturer with assurance that a process remains in a validated state during the routine manufacturing phase of the product lifecycle. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs according to risk, to shed light on common issues and to provide recommendations and best practices. Computer systems validation is relevant across the lifecycle of the informatics solutions to support CPV. Its scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements.

 

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