Warning Letter: Multiple mistakes in the study resulted in errors in the calculations, use of formulas, and statistical analyses. (ucm623581)

 Calculations could not be validated due to the PDF format (rather than Excel format) of the amended report, which did not include underlying calculations and formulas utilized.

View the original warning letter

Spreadsheet Validation: Ensuring Compliance with 21 CFR Part 11

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!

What Others Have Said about the Presenter:

• “This course gave us additional insight into what we could be doing be doing better.”
• “Super!”
• “Instructor was very knowledgeable and put the right emphasis on the key points.”

What You’ll Learn:

• How to design your spreadsheets to facilitate compliance and validation
• The part of a spreadsheet with the highest regulatory risk – and how to address it
• How FDA validates its own spreadsheets
• The expected contents of a spreadsheet validation package
• How to write spreadsheet requirements and specifications to facilitate good testing
• What must be included during spreadsheet validation testing
• The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

What You’ll Get:

• Tips to facilitate compliant spreadsheet design
• A checklist to determine if your spreadsheets are compliant with 21 CFR Part 11
• Practical examples of requirements, specifications and test scripts
• Links to a sample spreadsheet validation package, including functional requirements, design specification and executed test scripts.
• A copy of the white paper “MS Excel Spreadsheet Validation” prepared by Ofni Systems
• A copy of a FDA Laboratory Information bulletin describing their experience  with spreadsheet compliance software.
• A trial copy of ExcelSafe, which provides audit trails, password protection, user-level security and electronic signatures to MS Excel spreadsheets
• An  experienced and approachable instructor
• Time for questions and answers

Who Will Benefit:

• Managers and staff responsible for providing valid GxP data for spreadsheets
• Anyone who designs (or is considering designing) spreadsheets for use in GxP environments
• Regulatory professionals expected to defend the compliance of spreadsheets
• Quality professionals who audit company regulatory compliance or are responsible for the procedural requirements required for spreadsheet compliance
• Information technology professionals responsible for the administration of files or network locations storing spreadsheets incorporating GxP data
• Computer validation professionals in GxP environments
• The executives ultimately responsible for developing and maintaining a corporate culture of compliance, including those overseeing regulatory affairs, compliance, operations and strategic planning

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.