FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25). These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.
Why Track Training?
Implementing and tracking employee training is a sound business practice that allows companies to know:
Employees are properly trained to correctly perform their tasks.
Tasks a specific employee can perform.
Employees can competently perform specific tasks