SAP R/3 release change: Change, project and revalidation - Prerequisites of a 21 CFR Part 11 implementation

A release change is a challenge for the validation of every existing SAP system, as it is both an IT and revalidation project. The following article provides an integrated approach. It enables the project team in an early stage to consider the needs of computerized systems validation in the same way as technical aspects. It focuses on the view of validation. At the same time, it provides simple means (validation task force, playground system, screenplay) to enable all involved key players to follow a structured approach. Besides, the influence of regulatory demands like Part I I on the project work and different possible solutions to reach compliance is discussed. Finally, the influences of a release change on the general documentation and validation strategy as a chance to reach a higher degree of compliance is discussed.