Computer Validation (CSV) Computer System Validation

This seminar provides participants with a comprehensive overview of the current requirements for the validation of computer-assisted systems in the pharmaceutical and medical industries.

Initially, we examine what expectations authorities have of companies and how inspections typically proceed. Using Annex 11 as a guide, we demonstrate step by step how an inspection is structured and which aspects often lead to "Findings".

A central focus is the risk-based approach to the validation of GxP systems and the optimal use of GAMP 5. Additionally, current trends, technological developments, and their impacts on validation strategies are presented.

Other topics include handling Electronic Records and Signatures, cloud solutions, as well as the evaluation and delineation of interfaces. Complementarily, we show which project and qualification phases are critical, what tasks users undertake, and how supplier audits and commissioning are structured.

The conclusion covers the Periodic Review and the application of ALCOA+ to monitoring systems to ensure long-term compliance and data integrity.