Paper vs. Electronic Approaches to Training Documentation

What’s best for complying with relevant FDA and ISO requirements?

Food and Drug Administration (FDA) regulatory requirements (i.e., 21 CFR 211.25 and 820.25) and the quality management standards from the International Organization for Standardization (i.e., ISO 9001) mandate companies to execute and document employee training. These requirements ensure that employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of noncompliance and improve product quality. This article identifies the basis for the requirement, examines the associated challenges for meeting the requirement, and lists shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.

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Electronic training disadvantage

One unmentioned disadvantage to the electronic approach - it is very tempting to overload the individual with electronic training documents. Although e-training does a better job of tracking, it cannot distinguish employee comprehension. That requires good human oversight. I suspect the average intelligent person can effectively understand and comprehend between 6 and 12 documents. When the volume of documents that are pushed to the individual exceeds 20, then the comprehension rate falls dramatically. I'm willing to bet that organizations that implement e-training programs are pushing upwards of 50 documents through the system. From the standpoint of an auditor with any degree of common sense, that is just too many.