PDA Technical Report No. 32, Revised, (TR 32) Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (single user digital version)

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)

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