Excel Spreadsheet Validation for FDA 21 CFR Part 11 - PowerPoint PPT Presentation

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Excel Spreadsheet Validation for FDA 21 CFR Part 11

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This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. – PowerPoint PPT presentation

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Title: Excel Spreadsheet Validation for FDA 21 CFR Part 11


1
Excel Spreadsheet Validation for FDA 21 CFR Part
11
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Speaker Profile
  • Angela Bazigos is the CEO of Touchstone
    Technologies Silicon Valley, Inc. "Your Passport
    to Compliance". She has 30 years of experience in
    the Lifesciences industry spanning Project
    Management, Quality Assurance and Regulatory
    Affairs and has a patent aimed at speeding up
    Software Compliance.
  • Ms Bazigos is a member of the SQA CVIC (Society
    of Quality Assurance Computer Validation
    Initiative Committee), ASQ, DIA and RAPS and
    consults to investment groups on Lifesciences
    investments as well as Pharma / Biotech / Medical
    Device companies on compliance matters, including
    strategy, submissions, quality assurance and
    remediation following action by the FDA. She
    teaches classes on Compliance, 21 CFR 11,
    Computer Systems Validation, and Project
    Management both to investor groups and industry. 
     

3
Overview
  • This webinar will describe the regulatory and
    business requirements for Excel spreadsheets,
    using examples from FDA recommendations. It will
    then cover the design and installation of those
    Excel Spreadsheets, to ensure the integrity of
    the data, and will discuss how to ensure 21 CFR
    11 compliance during the development,
    installation and maintenance of a spreadsheet
    application.
  • 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.

4
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
  • How does the FDA Design and Use spreadsheets
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 compliance for Excel
    Spreadsheets

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