Roger A. Clemens

Sulfa drugs saved countless lives during World War II. Who would have thought that just five years after the discovery of sulfanilamide in 1932 that “Elixir Sulfanilamide” would cause 107 deaths in the United States?

Under the Food and Drugs Act of 1906, safety was not a prerequisite to the marketing of a drug. In this case, the “elixir” contained diethylene glycol, similar to the antifreeze, a well-known toxin. What followed this tragic incident and the public outrage was the passage of the Federal Food, Drug, and Cosmetic Acid of 1938. The new law required corporate America to demonstrate safety of drugs prior to marketing, and required the declaration of potential hazards. Had there been good recordkeeping and safety assessment documentation, the tragedy of 1937 could have been averted.

Obviously, the issues of safety and premarket approval linger in the pharmaceutical industry, and have moved into the mainstream of the food industry with regard to new ingredients and processing. During the past six decades or so, the food industry has entered the information age through consumer communications, regulatory documentation, and processing control records. It has, for the most part, established functional standards of practice and meaningful certificates of analysis. The mandates for these kinds of records in the food industry, however, have not been established except in the meat and poultry, seafood, and juice business. It is interesting to note that the Dietary Supplement Health and Education Act and the Good Manufacturing Practices umbrella (21 CFR Part 120) do not contain enforceable, mandatory recordkeeping provisions. However, it is incumbent on the food industry to recognize and respond to the necessity of record management systems.

In this information age, food safety remains the primary concern of regulatory authorities and consumers. Therefore, it is incumbent on the food industry to assume a proactive posture by electronically documenting the safety of its products. The growing mound of electronic records from ingredient certificates of analysis, process controllers, quality assurance data, quality control assessments, finished product label declarations, shelf-life evaluations, and shipping manifests are linked by a common thread. This recordkeeping is derived from the practices developed over the years by the pharmaceutical industry in its efforts to document not only compliance with applicable recordkeeping requirements, but also to keep pace with the demands of increasingly sophisticated technology.

The management of electronic records and electronic signatures in the pharmaceutical industry is likely, as time passes, to provide the contours for comparable standards in the food and supplement industries. The tasks associated with the implementation of standards for electronic recordkeeping/tracking in 21 CFR Part 11 that became effective in August 1997 are very challenging. Granted, Part 11 does not apply to most of the food or dietary supplement industries and is neither perfect nor perfectly clear. However, the intent of the section and its implementation should be seriously considered by these industries because in time, the current process involved in fleshing out Part 11 will become the baseline for judging the adequacy of the electronic data practices followed by all regulated industry.

While the electronic recordkeeping requirements that the pharmaceutical industry must meet may not be imposed on the food and dietary supplement industries any time soon, it makes good sense to be aware of them and that they provide a reliable basic framework for managing complex data systems. Here are a few steps these industries may elect to follow in managing those systems:
Assess current “quality” practices and behaviors and develop an action plan for assessment and remediation (correction of a fault or deficiency) relative to electronic records and signatures; conduct an electronics records inventory and submit the results to a repository database; establish a computer systems inventory and submit the results to a repository database; prioritize the computer systems that are subject to Part 11 compliance; determine the immediate systems needs using gap analysis and submit the results to a repository database; create a remediation plan; and execute and monitor the remediation plan.

General information concerning 21 CFR Part 11 is available via the Internet at, and a copy of 21 CFR Part 11 can be downloaded from By being aware of these regulations, the food industry can be ahead of the game.

Contributing Editor
Director, Analytical Research Laboratory
USC School of Pharmacy, Los Angeles