The Role of QA in Outsourcing Booklet

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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.

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, Jo20y 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

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

• BOOK10 for orders of 10 - 19 copies - 25% discount
• BOOK20 for orders of 20 - 49 copies - 33% discount
• BOOK50 for orders over 50 copies - 50% discount

This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.

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