Spreadsheet Validation: Ensuring Compliance with 21 CFR Part 11

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Ofni Systems

Software specifically intended for managing manufacturing processes and FDA submissions may very well be too complex and expensive for your firm’s needs – commonly available spreadsheet programs like Microsoft Excel could be a much better choice. But how can you create, validate and use off-the-shelf spreadsheet programs in your regulated environment without violating the provisions of Part 11?

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common they may seem almost invisible. But regardless of the program(s) you use, FDA expects the controls to be in place to ensure that GxP processes are validated and compliant with 21 CFR Part 11. FDA will look at your spreadsheets…it’s critical that you are prepared to prove your own Part 11 compliance.

You can confidently harness the versatility, functionality, ease-of-uses and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements.

On Thursday, February 7 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference for specific, practical advice on creating FDA-compliant spreadsheets, spreadsheet validation methodology and maintaining spreadsheets in GxP environments. You’ll even receive first-hand observations describing how FDA manages their own spreadsheets!

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To Register for this Conference:

Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.


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