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Training Control is Crucial to FDA-Regulated Companies
MasterControl Training Tech Paper describes how important training control is for life sciences. The FDA stipulates personnel training requirements for medical device companies in 21 CFR Part 820.25 and for pharmaceutical companies in 21 CFR Part 211.25. The paper details how MasterControl Training automates training control, tracking and reporting to ensure compliance with FDA CGxP requirements and 21 CFR Part 11.
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.