Privatsphäre-Einstellungen

Validierung von SAP R/3 unter GAMP 5

Maxim Bothe

Nycomed GmbH, Konstanz

Korrespondenz: Maxim Bothe, Nycomed GmbH, Byk-Gulden-Str. 2, 78467 Konstanz (Germany), e-mail: maxim.bothe@nycomed.com

Validation of SAP R/3 Using GAMP 5

Validation of SAP R/3 at Nycomed GmbH has in main aspects become much easier in the last years. Even though not all terms were changed to those introduced by GAMP® 5, the main concepts have successfully been implemented. The following decisions resulted in a faster implementation while retaining the same high quality level:
• focusing validation activities on areas with identified high risk taking into account GxP- and business process aspects,
• reduction of the number of documents by combining their content,
• introduction of automated methods for test planning and test execution with reduced manual coordination effort,
• consequent usage of qualified internal and external service suppliers who worked according to their own quality management system,
• organizing document review activities independent from the signature workflow resulted in faster approvals.

Key words Computervalidierung • GAMP® 5 • SAP R/3