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In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.
Why should you Attend: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session: