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Audit by an international pharmaceutical group
Project duration: 7 months
Brief description
Assistance of an IT consultancy company during an audit by an international pharmaceutical group. The audit is to examine the degree of compliance with the requirements for IT systems issued by the US authority FDA.
Supplement
During the auditing preparation phase, the documentation for the IT processes must first be consolidated and revised. Corresponding corrective measures must be planned and implemented for the weak points identified during the audit. Implementation of these measures must be documented for the auditors.
Subject description
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?
Overview
- Industries information technology
- Specialist tasks Audit, BPM: process design, documentation, FDA validation, QM in the project, supplier assessment
- DV tasks IT consulting
- Procedure model PTA project manual
Project period01.07.2004 - 31.01.2005
Contact
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