This current revision to the technical report by the PDA Industry Advisory
Board (IAB) reflects the lessons learned in four years of successful implementation.
Also described is how the original Supplier Auditing and Qualification Task
Group developed and tested a Process Model and Data Collection Tool. Use
of these tools will provide consistent audit information that can be shared
within the industry.
The objective to establish an audit process which meets the requirements
for consistency and reliability in execution while facilitating the sharing
of results has been achieved through the audit Process Model and Data Collection
Tool. The audit information, presented as an audit report, is usable in supporting
procurement activities and in inferring structural integrity of supplier products
when engineering and validating computer systems, meeting the FDA challenge.
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2004. Volume 58, Issue No. 5, Technical Report No. 32 Release 2.0.