is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, April 29, 2010. For more details or to register, please visit our site at www.fxconferences.com
Excel spreadsheets can provide medical device manufacturers with valuable enhancements to production and quality systems. However, they must be implemented correctly and validated, and any records created must comply with FDA requirements.
When a device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.
This presentation helps attendees understand the FDA device regulations related to Excel spreadsheets, beginning with methods to help ensure the spreadsheet produces the results you want. Our speaker explains how to use built-in validation tools, formula auditing and data, and also discusses the regulations for automated processes, found in 21 CFR §820.70(i), the requirements for a validation plan, and how to follow the FDA guidance document. The presentation also covers the electronic record aspects of the spreadsheet – requirements for electronic records and the issues raised, the current FDA guidance document, where FDA will exercise “regulatory discretion”, and what that means.
