Download Guidelines for Validation &Qualification, including Change Control

Contents
1.
Information to be included in the Validation Master Plan
page 03
2.
Example of a VMP currently in use in an NHS Hospital
page 07
3.
Change Control Request Form
page 11
4.
Specifications of what could be included in a User
Requirement Specification
page 15
5.
Example of a User Requirement Specification
page 17
6.
Specifications for inclusion in FDS
page 23
7.
Example of a Validation Plan
page 24
8.
Installation Qualification, Operational Qualification
And Process Qualification
page 29
9.
Example of Validation Protocol
page 32
10.
Example of a qualification Proforma
page 34
11.
Validation sign off report
page 49
12.
Acknowledgements and Declarations of interest
page 50
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