What elements should be contained in a validation plan for Excel spreadsheets?
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]
Would you like to discover more?
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
