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Book Training Unit 3

$20.00

Chapter 4 The Auditable Computer Validation Package, Appendix 4.1 and 4.2

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Chapter 4 The Auditable Computer Validation Package, Appendix 4.1 and 4.2

The focus for Unit 3 is how to structure a standard computer validation package that will pass audits and inspections. It provides a model that can be used for any system and shows how the model works for operational qualification (OQ), installation qualification (IQ), and performance qualification (PQ). Finally a standard format for validation plan and summary report is given. Then Appendix 4.1 and 4.2 provide project examples of the validation plan and summary report for an Excalibur LC/MS system.

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