What elements should be contained in a validation plan for Excel spreadsheets?

28.02.2022

Question of the Week

The following elements should be contained in a validation plan for Excel spreadsheets:
• Specifications (User Requirements Specification, URS)
• Risk assessment
• Creation incl. system documentation
• Test planning (planning of measures, see below)
• Implementation of reviews and tests
• Report including description of error handling/the review of all documents/the final evaluation

[GMP Compliance Adviser, Chapter 9.H]

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