Data recorded in MS and Excel

Dear Forum,

As a part of software validation in pharma applications, broadly it is considered to validate PLC based and equipments controlled through customised softwares.
Do the data entered in MS or Excel needs to be validated,pls give some references.


If you go to the warning letter section in the FDA site, you will find dozens of warnings and citations given out on spread sheets, PLC’s and software in general.

All such equipment used in the production of regulated product must be validated.

For production; read every process, every test, every calculation, every record, every assay, and all other activities that are used to produce/test/pack/store such a product.

Alex Kennedy