The webinar begins with Excel methods to help ensure the spreadsheet produces the results you want. 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.

The webinar shifts to the regulations for automated processes, found in 21 CFR §820.70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of software application. The webinar explains FDA’s thinking and shows how to follow the guidance document.

Lastly, we look at the electronic record aspects of the spreadsheet. 21 CFR §820.180 provides General Requirements for records. Part 11 has additional requirements when these are electronic records. We look at the requirements for electronic records and some of the issues these requirements raise. We also examine the current guidance document on electronic records and explain where FDA will exercise "regulatory discretion" and what that means.

We 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

Why should you attend: 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.

Unfortunately, many well meaning intentions may fail to satisfy the regulations. 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.

The next easy step is to eliminate the form used in the manual calculation. It would straightforward, as the next step, to reduce the paperwork and just keep the calculations in the spreadsheet. This is potentially an "electronic record", and may violate 21 CFR Part 11.

If manufacturers don't understand the regulations, they could create regulatory problems that are will be hard to fix.

Areas Covered in the Session:

• Overview of the regulations
• Automated processes
• Production and process changes
• General record keeping requirements
• Electronic records
• Excel Validation
• Setting the validation criteria
• Data types
• Using lists to keep data consistent
• Developing an input message
• Developing an error warning message
• Using the Excel Convert Function
• Changing the unit of measure
• Excel Formula Auditing
• Tracing precedents and dependents
• Watching formulas
• Error checking
• Circle Invalid Entries
• Excel Protection
• Locking and unlocking cells
• Protecting a worksheet
• Protecting a workbook
• Selecting passwords
• Track Changes
• How to turn it on
• The time limit for tracking changes
• Viewing history
• 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
• Other requirements
• The guidance document
• Enforcement discretion
• Electronic records . . .
  • in place of paper format
  • in addition to paper format
  • records submitted to FDA in electronic format

Who Will Benefit: 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