21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets

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Hundreds of 483’s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.

In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets.

This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:

  • Strategies for how to document and validate Access databases and other software applications based on databases.
  • How to add audit trails to databases and spreadsheets
  • How to define requirements quickly.
  • Managing change control and common change control mistakes to avoid.
  • How to document inputs, code and security settings.
  • How to properly secure the data and code.
  • Access security settings for multiple users.
  • Common settings applied to limit user actions.
  • Details on when and where to use electronic signatures.
  • Advanced techniques for adding electronic signatures
  • Inactivity timeouts, and controls for users and passwords.
  • Tips for efficient database testing.
  • Learn about how the FDA secures their own databases and spreadsheets

e-Conference, Presented by the Executive Conference Corporation