Validating excel spreadsheets

30-May-2019 11:13

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.Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries.From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with computer systems validation activities.Erroneous calculations due to data remaining from previous calculations must be avoided.

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Conduct a periodic status review throughout the project implementation.Spreadsheets also need to comply with a number of requirements.