Audit by an international pharmaceutical group

The IT service provider audit is performed as part of a supplier assessment. All aspects of the software life-cycle are audited, with special emphasis on the following aspects: – Does the supplier have an appropriate and functioning quality assurance system? – Are the legal requirements (particularly the FDA) complied with? – Is the product validated with the appropriate procedure? – Are the IT processes fully documented and is this documentation checked and adapted on a continuous basis?