Focussing on mySAP ERP, SAP NetWeaver Exchange Infrastructure and SAP Solution Manager, the questionnaire comprised 409 questions. 14 auditors and 25 SAP auditees have been involved during this 5 day software vendor audit.
The PVG-SAP is an interest group for the pharmaceuticals industry and medical-equipment vendors which aims to:
- make constructive and progressive contributions toward the further development of quality assurance measures and qualification of SAP software, based on mutual understanding between group members and SAP AG
- bundle requirements in the pharmaceuticals industry and forward them to SAP AG
- use mutual information exchange to develop procedures and sample documents for a systematic validation process
- devise functions and processes to promote standardization
- contribute toward cutting the validation costs of SAP applications in our own companies and
- develop a mutual understanding between the software vendor SAP and health authorities