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.

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 Tuesday, February 14, 2012 at 1:00 EDT, join FOI Services and Daniel Waterman 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 Daniel Waterman

Daniel Waterman is the Validation Manger for Ofni Systems, Inc., a software provider and Part 11 consulting firm. He has a strong background in software compliance and computer system validation. Daniel has managed numerous spreadsheet validation projects for clinical, laboratory and quality groups. Daniel has more than a decade of experience working for and consulting to FDA-regulated companies, including compliance and validation training, managing validation projects and assisting companies to develop and maintain procedures required for regulatory compliance.

Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal Validation Document Generator software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.

Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. For more information, contact Ofni Systems at (919) 844-2494, via email at Info@OfniSystems.com, or by visiting www.OfniSystems.com.