Validating excel spreadsheets
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.
(View sample warning letters relating to spreadsheets.) Ofni Systems, a leader in spreadsheet validation, can ensure that your spreadsheets are compliant with all regulatory requirements. This includes: Step 2: Document design requirements.
Design specifications include: Step 3: Develop and Execute Test Plans.