While the convenience of spreadsheets is undeniable, it’s vital to remember they’re not infallible tools. Just as we rigorously test and analyze other critical components of our operations, spreadsheet validation must become an integral part of our data management strategy. By embracing validation techniques, we transform them from casual calculators into trusted sources of truth, safeguarding our decisions, protecting our businesses, and ultimately, building a foundation of data integrity.
A spreadsheet’s functional requirements are prepared, considering both user requirements and functional specifications.
Develop the spreadsheet, ensuring all parameters are considered for the outcome desired.
Set up and execute the protocol to test the design of the spreadsheet against the requirements.
Set up and execute the protocol to test the spreadsheet performance against the user needs.
After testing is complete, a final report on the validation of Excel spreadsheets is prepared summarizing the testing results, explaining and resolving any deviations, and confirming the validation.
Under 21 CFR 11.10 Controls for closed systems, all spreadsheets that are used to facilitate the product and/or quality system decision-making processes need to be within compliance, including requirements for validation, accurate copies and protection of records, limited system access to authorized individuals, audit trails, authority, operational and device checks, training, electronic signatures, and change control.
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The trustworthiness of data is also critical to comply with regulatory requirements. Validated data is more reliable and can be trusted for making informed decisions.
Good Automated Manufacturing Practice (GAMP) by ISPE provides a detailed framework for the validation of Excel spreadsheets which is primarily adopted by the international regulatory authorities. It is essential to determine which spreadsheets require validation based on their impact on product quality and regulatory compliance.
Spreadsheets should be considered for routine revalidation and particularly when an upgrade to the program is conducted to address the effectiveness of the validation parameters.
Ready to learn more about how AlvaMed can assist in spreadsheet validation?
Schedule a time to discuss with Mark.
