The Age of Electronic Accountability: How to become compliant

November 4, 2004
/ Print / Reprints /
/ Text Size+
By definition, Part 11 deals with computerized records. Your first step should be to contact the software vendors who provided you with any systems you currently have in your plant. Ask these vendors what they are doing about Part 11. Most vendors who serve the food industry are aware of the issues and are proactively addressing them. However, do not assume that what these vendors are doing is satisfactory. It is your responsibility to determine what you need for compliance given an interpretation (regulatory and/or legal guidance usually required) and to implement a compliance strategy that meets your specific needs. Not all vendors can meet your needs with standard products.

If your current systems are custom, heavily modified versions of packages or just old, you face a bigger challenge. You may need to replace the existing systems. Both ERP and MES vendors are now touting systems that can help you comply. Be aware that the FDA does not validate software products. Remember that software suppliers can only assist you in compliance. If a software salesperson says, "We're compliant," he or she does not understand the regulations and a red flag should go up.

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

Fabulous Food Plant: Paramount Citrus

Learn more about this fabulous food plant in Food Engineering's article, found here.


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

What was your favorite part of FA&M 2014?

View Results Poll Archive


Food Engineering Magazine

Food engineering magazine 2014 april cover

2014 April

Catch a preview of the Powder and Bulk Show in this April 2014 edition of Food Engineering. Also, be sure to check out a coffee stick making a real stir and a major advancement in the the pet food industry.
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