What are the GxP software validation requirements for a datasheet that is put together in excel by querying a database and is used as objective evidence for a quality system?
What’s the risk of the record being wrong?
How do you know the data coming in is good? Are there checks for data bounds on the import? Is there error checking for incomplete data? Those might be areas to consider for assessment.
Are there data manipulations (calculations) done by the spreadsheet? If so, then the calculations would certainly be a candidate for validation.
Can the spreadsheet be changed after the import? Are there sufficient audit trails to enable the changes to be followed?
What do you do with the spreadsheet once populated? Is it printed out and the hardcopy serves as the official record or is it stored electronically?
Without knowing more, it’s hard to say exactly what validation (if any) would look like. The above are the types of questions to ask when determining what to do.
Hello Yodon, Thanks for replying. The data will be used as objective evidence for a CAPA or complaint etc. The data is obtained by basic SQL functions from an existing database. So the risk of data being wrong is really low. There are no data manipulations. Excel is merely being used as a medium to present the data to the user. The spreadsheet is locked and protected when provided to the user. There are no audit trails as it is static data and we store a copy of the data provided in a secure location. The data could be used as an attachment to an electronic quality record or may be printed out and attached to a paper record as well.