Spreadsheet Validation 101 : Create and Validate FDA Compliant Spreadsheets

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Tyson Mew, President of Ofni Systems, and Ofni Systems, Validation Manager for Ofni Systems will speak at IVT’s 12th Annual Computer and Software Validation conference in Philadelphia, PA, from April 26 through April 28. Ty and Daniel will present Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets on Wednesday, April 27 at 8:45 AM – 12:15 PM.

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.

IVT’s 12th annual event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical). Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away cutting edge information that can be immediately implemented.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets will cover:

Spreadsheets in GxP Environments

• How the FDA validates their spreadsheets
• Scale validation to spreadsheet functionality
• Required spreadsheet validation documents
• Design spreadsheets that facilitate compliance
• Requirements for compliance with 21 CFR 11

Writing Spreadsheet Functional and Design Requirements

• Write requirements that facilitate testing and detect common deviations
• Document Data Entry, Formulas and Calculations
• Documenting Macros

Test Protocols for Spreadsheets

• Focused testing
• Test spreadsheet inputs, outputs and compliance

Interactive Exercise – Validating a Spreadsheet

Participants examine a spreadsheet, determine the requirements for the spreadsheet and then create a suitable test case which verifies that the requirement has been implemented successfully. Participants are encouraged to bring their own example spreadsheets.

Bonus Materials

All conference participents will receive:

• A checklist to determine if spreadsheets are compliant with 21 CFR 11
• Sample spreadsheet validation package
• Whitepaper — “MS Excel Spreadsheet Validation”
• A trial copy of ExcelSafe that provides audit trails, password protection, user-level security and electronic signatures

About the Presentors

Tyson M. Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. He is the creator of ExcelSafe and has worked on hundreds of client spreadsheets and desktop database systems to make them compliant. Mr. Mew regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices. He is an active member of ISPE, DIA, PDA, SQA and the PEERS Group.

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.