Validating excel spreadsheets
Specific to these challenges are the validation of electronic spreadsheets or forms.The FDA defines validation as “The establishing of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” Spreadsheets and automated forms are included in this definition.The requirements documentation and level of testing described in the protocol are appropriate for this system; systems with additional complexity would require additionally complex requirements documentation and rigorous test protocols.The FDA and other regulatory bodies require spreadsheets to be validated and compliant with 21 CFR 11. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments.The easy to use calculations allow making calculations in a very convenient way. In a pharmaceutical environment, computerized systems need to be validated.Erroneous calculations due to data remaining from previous calculations must be avoided.
A Q&A issued by EMA provides the following answer: "Validation according to paragraph 4 of annex 11 is required at least for spreadsheets that contain custom code (e.g. Formulas or other types of algorithm should be verified for correctness." Therefore, appropriate controls for templates of spreadsheets must be in place.Document the management of these risks as part of the overall project plan (validation plan) or as a part of the specific risk management process.The validation plan of a project identifies the base methodology used to prove that the form or spreadsheet is usable for the requirements / process.We use Excel Safe, which provides MS Excel with audit trails, limited system access, password controls, and other technological tools.Ofni Systems will perform a free spreadsheet validation of one of your spreadsheets for qualified purchasers to demonstrate our validation method.