The Role of QA in Outsourcing eBooklet

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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, 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.

Contents

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

Authors

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

ISBN

978-1-904610-25-0

Published

March 2013