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The Role of Quality Assurance in Outsourcing


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Guidance on audits of third parties and related activities was perceived as an obvious gap in RQA's booklet portfolio and therefore in April 2008, the Publications Committee commissioned a booklet with the aim of providing guidance to new auditors, or to those inexperienced in the outsourcing process and in undertaking audits of third parties. As well as presenting the key elements of a competent outsourcing process and the role of Quality Assurance (where applicable), this publication identifies specific items and broad pointers for preparation of checklists for the audit/assessment of suppliers across all GxPs.


  1. Introduction
  2. Outsourcing in Business
  3. Vendor Audit Process
  4. Audit Components
  5. Specific GxP Considerations
  6. Service Management
  7. Bibliography and Further Reading


Caroline Bradshaw, John Dixon, Joy Eldridge, Sarah Howard, Angela Jennings, Kieran O'Donnell, Trev Simmons, Dympna Starling and Claire van Leersum



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March 2013



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