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.

This audio conference covers:

• How to use Excel’s built-in tools to ensure data accuracy and integrity
• FDA requirements for automated processes
• Expectations of the software validation guidance document
• FDA requirements for electronic records
• FDA’s enforcement plans and advice on electronic records

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who should attend?

• Quality Assurance/Quality Control
• Production and Process Engineers
• Design and Manufacturing Engineers
• Purchasing Managers and Agents