Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
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.
Available to download
Format: PDF (1 file - 1.46 MB)
Click here for the digital downloading instruction and Terms of Usage.