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

Published
Sep 2004
Pages
155
PDA Item Number
43236

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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.

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Table of Contents

Table of Contents:

  • Abstact
  • Introduction (Background)
  • Methods and Techniques
    1. Team Organization
    2. Scope of Work
    3. Research of Existing Audit Processes
    4. Survey of Stakeholder Needs
    5. The Process Model and Enablers
    6. Testing
  • Results
    1. Research of Existing Audit Processes
  • Survey of Stakeholder Needs
    1. Audit Process Model and Enablers
    2. Testing
    3. Systems Engineering and Validation Processes
    4. Discussion
    5. Short and Long Term Benefits
    6. Strategy for Implementation
    7. Supporting Infrastructure
    8. Extended Application
    9. Management of the Process
  • Conclusion
  • References
  • Appendix A: Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
  • Appendix B: Data Collection Tool Part 2: Audit Criteria Checklist
  • Appendix C
  • Appendix D: Respository Models
  • Appendix E: Performance Metrics

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