21 CFR 11 Compliance for Excel Spreadsheets

Dec 4, 2020 - 01:00 PM EDT
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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:

  • 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

Who will benefit: 

  • Quality VPs
  • Regulatory VP
  • IT VPs
  • Regulators
  • Regulatory Affairs professionals: Quality Managers, Quality Engineers, Small business Owners, GxP Consultants
Webinar Events
Attend Live Webinar
Dec 4, 2020 - 01:00 PM EDT

Duration: 90 Minutes

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session




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