The paper seeks to outline the increasing requirements for demonstrating that training has taken place within regulated industries and to examine how a learning management system can meet the most stringent requirements of best practice in this field.
The paper presents a review of regulated industries' requirements, especially 21 CFR Part 11.
Increasingly, regulated industries require companies to keep comprehensive records of training. The data and reports showing compliance with regulatory needs must be robust and come from an unimpeachable source. While manual record keeping can be easily flawed, electronic record keeping is not foolproof either – although one system now meets the requirements of the most stringent (US‐based) regulations.
This paper examines the growing requirements placed upon and the responsibilities of HR/training directors in regulated industries, and suggests a best practice method of providing tamper‐proof training records.
Ambrose, J. (2008), "A best practice approach to learning compliance management in regulated industries", Industrial and Commercial Training, Vol. 40 No. 3, pp. 142-145. https://doi.org/10.1108/00197850810868630
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