Training Controls

Software for Training Controls Assures Proper Training and Training Documentation for ISO and Regulated Companies

MasterControl Training Tech Paper describes how important training controls are 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 controls, 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 with training controls and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.

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Software for Training Controls (or Quality Training ) from MasterControl

The software from MasterControl for training controls, also sometimes referred to as a system for learning management (LMS), is described below:

• MasterControl Training consists of software for training controls that automates the assignment and monitoring of training tasks, the grading of online exams, and the sequencing of training courses. Any change to a document or a process that requires new training automatically initiates new training tasks when the change is approved by authorized personnel. These tasks are sent immediately via email to all employees affected by the change, in order to ensure the quickest response.
• MasterControl Documents organizes and keeps track of all documents in the system, including those related to training management or training controls.
• MasterControl Process enables GMP training to be integrated with other business processes such as change control, customer complaints, corrective/preventive action (CAPA), and audits for a completely connected approach to quality and compliance.

To Learn More about Training Controls

To learn more about training controls in general and the training application from MasterControl, please feel free to contact a MasterControl representative.