Technical Reports: Print

PDA Technical Report 32, Revised, (TR 32) Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (print version) - 30% Off

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.


Table of Contents:

Abstact
Introduction (Background)

Methods and Techniques

  • Team Organization
  • Scope of Work
  • Research of Existing Audit Processes
  • Survey of Stakeholder Needs
  • The Process Model and Enablers
  • Testing

    Results
  • Research of Existing Audit Processes

    Survey of Stakeholder Needs
  • Audit Process Model and Enablers
  • Testing
  • Systems Engineering and Validation Processes
  • Discussion
  • Short and Long Term Benefits
  • Strategy for Implementation
  • Supporting Infrastructure
  • Extended Application
  • 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



  • Date of Publication: September 2004
    ISBN Number:
    Format:
    Number of Pages: 150
    Binding: Softcover