Electronic Standard Operating Procedures eBooklet

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RQA published a Guideline on the Management of Electronic Standard Operating Procedures in December 1998. Since then companies working in the GxP industries have gained experience of electronic SOPs through the design and implementation of their own systems. In September 2001, interested parties from a variety of user organisations formed a Working Party under the auspices of RQA to co-operate and produce an update to the 1998 guideline in the form of an RQA booklet.

In 2013 the RQA  Computing Committee reviewed and re-issued the booklet due to ongoing demand for the booklet, reflecting the evolution of eSOP systems since 2000.

Contents

1. Introduction
2. Definitions
3. System Components and Functions
4. eSOP System Types
5. Benefits of eSOP System
6. Requirements for eSOP System
7. Choosing and Implementing a System
8. Auditing the System
9. Bibliography and Further Reading
10. Acknowledgements

Authors

Barbara Kay-Farrow, Matthew Davies, Tony Harrington, Chris Montgomery and Sarah Pickersgill

ISBN

978-1-904610-30-4

Printed

January 2014