VALIDATION OF EXCEL SPREADSHEETS IN ACCORDANCE WITH FDA 21 CFR PART 11

This webinar will provide an overview of the regulatory and commercial requirements for utilizing excel spreadsheets, using examples drawn from fda directives. After that, it will go over the design and installation of those excel spreadsheets in order to guarantee the accuracy of the data. Additionally, it will go over how to guarantee compliance with 21 CFR 11 throughout the process of developing, installing, and maintaining a spreadsheet application. Why should you bother to come? Spreadsheet programs such as Microsoft Excel are often used in settings that must comply with 21 CFR 11, despite the fact that they were not developed with the intention of being used in regulated environments and that their development is not optimized for 21 CFR 11 compliance. Nevertheless, the FDA anticipates that spreadsheets will be compliant, and failure to comply with this expectation may result in a warning letter. As a result of this, validation of the apps used for excel spreadsheets is necessary as part of an environment that complies with 21 CFR 11. areas such as these were discussed throughout the session: specifications needed for Excel spreadsheets validation instructions for Fda Part 11 difficulties with compliance caused by spreadsheets design requirements for 21 CFR 11 compliance How does the Food and Drug Administration construct and make use of spreadsheet documentation for part 11 future trends in 21 CFR 11 compliance for excel spreadsheets? who will come out on top: managers focused on quality engineers who ensure quality proprietors of little enterprises auditors both inside and externally management representatives inspectors and consultants from the FDA rapid communication: globalcompliancepanel.com in the United States may be reached at 800-447-9407 or 302-288-6884. webinars can be requested at globalcompliancepanel.com. http://www.globalcompliancepanel.com

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