Spreadsheet Validation: 21 CFR Part 11 Compliance – 2/3/2011

Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in GxP environments without violating the provisions of Part 11?

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

Register for FOI Services’ Spreadsheet Validation: 21 CFR Part 11 Compliance!

You can learn how to harness the versatility and functionality of spreadsheets, giving you and your organization all of the benefits of electronic data systems while remaining compliant with all regulatory requirements.

On Thursday, February 3 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about spreadsheet compliance and validation, including specific, practical advice on creating compliant spreadsheets, spreadsheet validation methodology and maintaining spreadsheets in GxP environments.

What You’ll Learn

• How FDA validates their own spreadsheets
• How to design your spreadsheets to facilitate compliance and validation
• The part of a spreadsheet that has the highest regulatory risk (and how to address it)
• The expected contents of a spreadsheet validation package
• How to write spreadsheet requirements and specifications that facilitate good testing
• What must be included during spreadsheet validation testing
• The most common deviations discovered during spreadsheet validations (and how to focus 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 11
• Practical examples of requirements, specifications and test scripts
• Links to a free sample spreadsheet validation package, including functional requirements, design specification and executed test scripts.
• A free copy of “MS Excel Spreadsheet Validation”
• 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

Audience Suitability

• Managers and staff who are responsible for providing valid GxP data for spreadsheets
• Anyone who designs spreadsheets for use in GxP environments
• Regulatory professionals who must defend the compliance of spreadsheets
• Quality professionals who may audit spreadsheets or are responsible for administrating procedural requirements required for spreadsheet compliance
• Information technology professionals responsible for administrating files or network locations storing spreadsheets containing GxP data
• Computer validation professionals working with spreadsheets for use in GxP environments
• Executives who are planning their company’s futures

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.