Below MasterControl offers a variety of complimentary training-oriented downloads, including a Training tech paper that describes how important training controls are for life sciences organizations. The FDA stipulates personnel training requirements for medical device companies in 21 CFR Part 820.25 and does the same for pharmaceutical companies in 21 CFR Part 211.25. The tech paper details how software solutions like MasterControl Training automate training controls, tracking, and reporting to ensure compliance with FDA CGxP requirements and 21 CFR Part 11.
The paper identifies the basis for the requirement and examines the associated challenges for meeting the requirement with training controls and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the regulatory requirements for tracking is presented.