Continued Process Verification

Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers 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.