21CFR 11 Compliance for Excel Spreadsheet

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

19 Jun 2014 at Online

Computer Science

21CFR 11 Compliance for Excel Spreadsheet 19 Jun 2014 Online
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Course Objective:
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.
Course Outline:
Requirements for Excel Spreadsheets
FDA Part 11 Validation Guidance
Compliance Problems with Spreadsheets
Design Specifications for 21 CFR 11 compliance
Documentation for Part 11
Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Target Audience:
Quality Managers
Quality Engineers
Small business owners
Quality VPs

From: June 19, 2014 10:00
To: June 19, 2014 11:00



Computer Science

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