Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District will give a presentation on “Validation of Excel Spreadsheets in a Regulated Environments.”
Many lab decisions are being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of this tool however might become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on “on-the fly” worksheets that were created for one-time use. This session will address these concerns and offer strategies and approaches for response.
A central part of this discussion will detail their experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11. Ofni Systems President Tyson Mew will be available following the presentation to answer any questions about ExcelSafe and spreadsheet validation.
Presented by Interphex