How to Use and Validate Excel Spreadsheets to Ensure Compliance under FDA’s 21 CFR Part 11

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Ensure Compliance with 21 CFR Part 11 to Avoid FDA 483s and Warning Letters

In FDA-regulated industries, it is imperative that manufacturers for drugs, biologics, biosimilars and medical devices including IVDs demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements.  The FDA frequently states in their warning letters, “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….” as reasons for enforcement action.

Join expert speaker Dr. David Lim, in this session, to learn to adequately develop and implement Excel spreadsheet computer system validation in your organization in compliance with Part 11. You will get in-depth insights to improve your awareness in order to better implement Part 11 and computer system validation requirements to avoid citations in 483s and warning letters. This session will provide an opportunity for you to check your current practices and ensure compliance for Part 11 requirements for Excel spreadsheets of GxP data.

This session will help you adequately develop and implement Part 11 and Excel spreadsheet computer system validation, so you can ensure quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.

Session Highlights

  • Laws and Regulations
  • Definitions
  • Compliance requirements for excel spreadsheets under 21 CFR Part 11
  • Excel spreadsheets for GxP data
  • Protecting excel spreadsheets including cells, rows and columns
  • FDA enforcement actions on the excel spreadsheets
  • How to avoid FDA 483s and warning letters
  • Excel and computer system validations
  • Excel data validations
  • Implementing excel audit trails
  • Excel validation documentation requirements
  • Understand all aspects of Part 11 compliance requirements for excel
  • PASS – IT Recommendations

Who Should Attend

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance officers
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • Laboratory personnel
  • IT professionals
  • Research & development
  • Consultants
  • Contractors/subcontractors

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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