Spreadsheet Validation – FAQs

When is spreadsheet validation required?
When a spreadsheet is used to support a quality decision it should be validated. Therefore, any spreadsheets used for calculation of analytical results, to support batch release, to carry out trend analysis and to assign risk levels are examples that would require validation.

Is validation mandatory?
As with a lot of things we have to do in pharmaceutical and medical devices the answer is yes, but it is not exactly obvious where it is mandated! In Europe the requirement is in Annex 11 (Volume 4, Eudralex). In the USA for pharmaceuticals it is in 21 CFR 211.68 and for medical devices in 21 CFR 820.30.

Do I have to validate Microsoft Excel?
No, it is the application and usage that needs to be validated. Basic spreadsheet functionality is accepted as proven, however the appropriate use of it needs to be validated.

How do I validate a spreadsheet?
The level of validation required should be commensurate with the risks associated with the application the spreadsheet is supporting. Complexity is also a factor, more complex spreadsheets (e.g. with Visual Basic elements) require more validation.

Is it only required for laboratory applications?
No! A lot of people think this is the case, but any spreadsheet used to support the quality system must at least be subject to a formal assessment to determine if validation is required.

Where can I get help?
J-GMP Consultancy have many years of experience in computerised system validation and regularly carry out spreadsheet validation for clients, ranging from simple calculations to complex Visual Basic driven applications, please contact us for a chat about your requirements.

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