Excel could be used in regulated setting for all functions, provided it is appropriately tested and validated to ensure accuracy of data and analysis, appropriate process documentation and training are carried out to avoid risk of errors, it has adequate security measures to track source and avoid alteration, and it is auditable. Read further to learn what are the design specification requirements for Excel spreadsheets.
For implementing design specifications break each worksheet into four areas: inputs, processing, outputs and security. The cells where users are expected to enter or update data could be entered using automated systems. Document any rules to enforce proper data entry like input format, logic checks and consistency checks.
Design Specifications Processing
Design specifications processing includes, formulas used on the sheet. It may include custom macros or codes. Use custom formulas or built-in formulas in Excel. Best practice is to define the formula input cells with descriptive variables.
Design Specifications Outputs
Output areas of the sheet lists the cells or range of cells that contain the final result of calculations. It may include charts/figures, export function to final result sheet or report.
Design Specification Securities
Design specification securities describe settings to protect data: All non-input cells should be locked, open, read, read/write, edit access lists, storage, saving, and altering rules.
Installation qualifications are usually limited to making sure the file is in a location where users can access it. It defines safety features and security aspects, tests cases for checking that Excel has been installed correctly in user environment, results of executing scripts, deviations from expected results (if any).
The operational qualifications
The operational qualifications of Excel are: verifying formulas, macros, and also to test the security of each sheet to verify all non-input cells are locked to prevent changes, worksheet operating procedures. Tests cases for checking that the worksheet does what it is intended to do in user environment, results in executing scripts, deviations from expected results (if any).