subject: Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel [print this page] Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel
Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets.
These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar 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 seminar 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 seminar 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
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