Audit of an electronic batch record (EBR)

Audit elektronischer Herstellbericht EBR - QFINITY

Our medical technology client wants to establish the electronic batch record as the central tool for production documentation (including archiving). The commissioned audit will verify the regulatory compliance (USA / EU) of the implementation project, the computerized processes for producing an electronic batch record and the implementation of the process in an electronic tool (SAP), while also checking for weaknesses in the logistics workflow.

Implementation and Validation of an UDI-SolutionAufbau und Validierung einer UDI-Loesung FDA - QFINITYSAP-Releasewechsel S/4HANA - QFINITYSAP Release Change at a pharmaceutical manufacturer