The Age of Electronic Accountability: Ideal solution attributes

November 4, 2004
/ Print / Reprints /
/ Text Size+
Looking at various technology suppliers who offer Part 11 solutions, we constructed some of the attributes of the ideal solution. While we do not believe that any one supplier offers all these features, it can serve as a useful checklist for food companies looking for 21 CFR Part 11 solutions.

Electronic signature placements-Where should electronic signatures exist within your system? The FDA suggests a risk-based approach. As you might expect, different companies interpret the requirements differently. That results in different views of where electronic signatures are required. Some vendors decide in advance where the electronic signatures are placed and give the food company a minimal amount of flexibility. (The company may be able to "turn-off" the signature of a specific transaction but cannot add them in other places.) Other vendors place the electronic signature function within the infrastructure of the product and give the food company the option of placing the signatures anywhere in the system. In general, this second, more flexible approach is more desirable than the former, more rigid approach.

Document-Part 11 asks for electronic signatures of electronic documents. However, most vendors have interpreted this to mean an electronic signature on the transaction. Users often feel uncomfortable signing the transaction because it does not represent the total picture. Not all of the information that would be on a paper document appears on the transaction screen. At least one vendor has chosen to provide the user with a complete picture of the document before requesting a signature. The document, including all appropriate information, is displayed on the screen in its entirety. This document is saved as a pdf file as signed, along with the signatures. This approach minimizes user reluctance.

Data security-How the documents or information are stored is of importance to the FDA. They are concerned about the safety and integrity of the documents. We suggest that documents are best kept in read-only format and on a secure, dedicated server.

Did you enjoy this article? Click here to subscribe to Food Engineering Magazine.

You must login or register in order to post a comment.



Image Galleries

Plant of the Year 2014

Blue Diamond Growers was chosen as Food Engineering's 2014 Plant of the Year. The Sacramento-based company is the world’s largest producer of almonds and almond ingredients.


Burns & McDonnell project manager RJ Hope and senior project engineer Justin Hamilton discuss the distinctions between Food Safety and Food Defense as well as the implications for food manufacturers of the Food Safety Modernization Act.
More Podcasts

FSMA Audit

What is the is most important step you have taken to become ready for a FSMA audit?
View Results Poll Archive

Food Engineering

FE September 2014

2014 September

The September 2014 issue of Food Engineering explores how lean manufacturing, quality improvements and increased automation helps processors meet rapidly changing demands. Also, read how robotics, advanced machine controls, software and OEE are just a few of the tools that can boost productivity on packaging lines.

Table Of Contents Subscribe


Food Authentication Using Bioorganic Molecules

This text provides critical tools and data needed to augment routine food analysis and enhance food safety by aiding in the detection of counterfeit, and potentially deleterious, foods.

More Products

Clear Seas Research

Clear Seas ResearchWith access to over one million professionals and more than 60 industry-specific publications,Clear Seas Research offers relevant insights from those who know your industry best. Let us customize a market research solution that exceeds your marketing goals.

Food Master

Food Master Cover 2014Food Master 2014 is now available!

Where the buying process begins in the food and beverage manufacturing market. 

Visit to learn more.


FE recent tweets

facebook_40.pngtwitter_40px.pngyoutube_40px.png linkedin_40px.pngGoogle +