SAP Successfully Passed Full QMS Audit

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