Spreadsheet Compliance


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2009 Interphex Puerto Rico Press Release

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Raleigh North Carolina – Monday, February 2, 2009 – Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District presented “Validation of Excel Spreadsheets in a Regulated Environment” at Interphex Puerto Rico on January 29, 2009.

Many lab decisions being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of Excel spreadsheets can become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on “on-the fly” worksheets that were created for one-time use. This session addressed these concerns and offered strategies and approaches for response.

Mr. Cantellops also discussed his experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11.

Ofni Systems is a leader in the field of spreadsheet compliance and validation. ExcelSafe provides the technological tools to MS Excel spreadsheets required for Part 11 Compliance, including audit trails, electronic signatures and user-level security.

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 its 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.

Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494



Validation of Excel Spreadsheets in a Regulated Environment

Tags: | |

Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District will give a presentation on “Validation of Excel Spreadsheets in a Regulated Environments.”

Many lab decisions are being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of this tool however might become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on “on-the fly” worksheets that were created for one-time use. This session will address these concerns and offer strategies and approaches for response.

A central part of this discussion will detail their experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11. Ofni Systems President Tyson Mew will be available following the presentation to answer any questions about ExcelSafe and spreadsheet validation.

Presented by Interphex





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