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Excel Spreadsheets and FDA Device Regulations Webinar by GlobalCompliancePanel

11/15/2013 10:00 AM - 11:15 AM

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 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


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

Dan 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.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

Event Link -

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