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21 CFR 11 Compliance for Excel Spreadsheets Description: 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. Spreadsheet Applications such as MS Excel are frequently us ed 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. Objectives of the Presentation: o Requirements for Excel Spreadsheets o

FDA Part 11 Validation Guidance

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Compliance Problems with Spreadsheets Design Specifications for 21 CFR 11 compliance

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Documentation for Part 11

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Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

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Who can Benefit: o Quality Managers o Quality Engineers o

Small business owners

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GxP

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Consultants

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Quality VPs

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IT VPs

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21 CFR 11 Compliance for Excel Spreadsheets