Article | June 3, 2024

6 Quick Tips For Excel Spreadsheet Validation

Source: ProPharma
Excel-Spreadsheet-iStock-1141353530

Are you utilizing Microsoft Excel spreadsheets for GxP activities, often as reusable templates? Have you considered validating these spreadsheet templates? Perhaps the individual who created them excels in Excel but lacks validation expertise. Are validation concerns hindering your use of spreadsheet templates? Our 6 quick tips for Excel spreadsheet validation can provide valuable guidance through this process.

It's common for spreadsheet templates to be created to automate calculations, from simple impurity calculations to complex statistical analyses of clinical studies, sometimes incorporating Visual Basic for Application (VBA) macros. These spreadsheets may contain critical data and be pivotal in decision-making processes.

While some view medical spreadsheet templates as mere calculators, they should be treated as applications. Generated records are electronic and must comply with EU’s Annex 11 and FDA’s 21 CFR Part 11 regulations.

Did you know that creating a medical spreadsheet template makes you a software developer? Your internally developed software may even fall under the highest GAMP software category 5 application.

However, don't fret. With a well-structured roadmap and our expert tips and tricks, navigating the intricate landscape of spreadsheet validation becomes more manageable. Let's dive in!

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