Excel Spreadsheets and FDA Device Regulations

FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter.For example; a manufacturing engineer may recognize that an Excel spreadsheet could reduce the possibility of error in a manual calculation. On its own, the spreadsheet would be a valuable Preventive Action. However if the spreadsheet is not validated, approved, and documented properly it may create a problem during an FDA inspection. An unvalidated spreadsheet violates the QSR requirements for automated processes.

If manufacturers don’t understand the regulations, they could create regulatory problems that are will be hard to fix. Attend this webinar to know FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11 Electronic Records and Signatures. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, we explain the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, we use Excel 2003 to illustrate the tools .

In this Webinar we will discuss the following issues:

• The pitfalls of using Excel without a good regulatory plan.
• How to recognize when you are using software in production or the quality system.
• The use of Excel tools to help ensure spreadsheets are built correctly.
• The FDA’s requirements and expectation for production and quality system software.
• The reason for Part 11 and some of the implications
• The requirements of Part 11 for electronic records and the current guidance document

Areas Covered in the seminar:

• Overview of the regulations (Automated processes, Production and process changes, General record keeping requirements, Electronic records).
• Excel Validation.
  • Setting the validation criteria
  • Developing an input message
  • Developing an error warning message
• Using the Excel Convert Function.
  • Changing the unit of measure
• Excel Formula Auditing.
• Excel Protection.
• Understanding automated process
  • The regulation (The concept of validation, Establishing intended use, Establishing the validation protocol)
• The guidance document
• How much validation evidence is needed?
• Defined user requirements
• Validation of off-the-shelf software and automated equipment
• Electronic records.
  • General requirements for records
• Definitions from Part 11 (Electronic records, Closed systems, Open systems)
• Summary of requirements (Validation, System access, Audit trail)
• The guidance document
  • Enforcement discretion
  • Electronic record

Learning objectives:

The participant will learn:

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

Who will benefit:

This seminar is designed for people in medical device manufacturing who might use Excel spreadsheets. These are people involved in setting up any part of the production or quality system. Employees involved in selecting and evaluating contract manufacturers also need to understand these regulations.Attendees should have knowledge of manufacturing and quality system processes. This typically includes:

• Quality Engineers
• Production and Process Engineers
• Manufacturing Engineers
• Design Engineers
• Purchasing Managers
• Purchasing Agents
• Supplier Quality Engineers
• Quality Supervisors
• Quality Inspectors
• Quality Managers
• Quality Audit Managers
• Quality Auditors

Instructor Profile:
Daniel O'Leary, is the 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.