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Implementation of the Part 11 ToolkitTM

Implementation of the toolkit can be handled in one of three ways

  • Installed by Ofni Systems

    We handle all the details of implementing the Toolkit into existing Access programs. Once your program has been submitted via our secure submittal process, we discuss the changes with you and then get to work. Most implementations take 8 hours or less.

  • Install it yourself

    We provide on-site training courses for installing the Part 11 Toolkit. This 2-day course covers a full review of 21 CFR Part 11 and how it is applied to database-driven programs, a complete walk-through of how to install the Toolkit into any Access program, and tips on how you can make improvements to your current program.

  • Installation by third-party solution providers

    We have certified other firms to install Toolkits. If you are looking for companies in your area or would be interested in becoming certified to provide Toolkits, contact us for details.
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CDER indicating increased inspections for compliance with 21 CFR 11