Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

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Ofni Systems


Tyson Mew, president of Ofni Systems, will speak at IVT’s 14th Annual Computer and Software Validation conference in Philadelphia, PA, from April 17 through April 19. On Thursday April 18, 2013, Ty Mew will be a featured speaker, giving the presentation:  Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets.

Learn how to Create and Validate Spreadsheets in FDA Regulated Environments

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.

Institute for Validation Technology

IVT’s 14th Annual Computer and Software Validation conference is a three-day conference to discuss evolving computer and software validation practices. From the emergence of virtual networks, cloud computing and social media, the urgency of securing data integrity and complying with global regulations has never been greater. This conference aligns global regulations, best practices and case studies featuring the best CSV speakers to discuss developing, implementing and maintaining best validation practices in regulated environments.

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

Registration information for the 14th Annual Computer and Software Validation conference is available.


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