Software for Training Controls Assures Proper Training and Training Documentation for ISO and FDA Regulated Companies
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.
MasterControl Software Solutions for Training Controls
MasterControl offers software solutions that have been specifically engineered to automate training controls and integrate training with the entire quality system. MasterControl’s core integrated modules function together to help life sciences companies comprehensively manage their training controls:
- MasterControl Training is a training controls software application 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 additional training automatically initiates training tasks when the change is approved by authorized personnel. These tasks are sent immediately via email to all employees affected by the change 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 makes it possible to integrate GMP training with other quality processes such as change control, customer complaints, corrective/preventive action (CAPA), and audits for a completely connected approach to quality and compliance.
Features and Benefits of MasterControl's Training Controls Software
- Centralized document repository: All training documentation is stored in MasterControl’s secure and centralized electronic system. This dramatically simplifies search and retrieval during compliance inspections and external or internal audits.
- Automated management of training tasks: Trainees are electronically notified when new training tasks are assigned. Training tasks can also be electronically monitored and verified by managers and reviewers.
- Verification timeliness: When a “course verifier” role is assigned, the system can automatically send a verification task to multiple users. If a particular supervisor is not available to verify a training task in a timely manner, MasterControl’s training controls software automatically forwards the task to another verifier to ensure the task is completed according to schedule.
- Exams graded online: MasterControl’s training controls solution also includes an automated online exam grading feature that can be used as proof of personnel competency.
- Advanced tracking capabilities: MasterControl gives users the ability to track training tasks by history or status. Training record appear as being either “in process” or “complete” if tracked by status. Revisions and document approval history may also be reviewed using the history tracking feature.
- Training completion dictates document effectivity: MasterControl’s training controls software solution permits courses to be arranged so that relevant documents only become effective once all essential trainees have completed the required training courses associated with the document.
- Robust analytics and reporting functionality: The advanced analytics and reporting capability of MasterControl's training controls software provides standard and customized reports to confirm training program status. MasterControl also tracks and identifies any training deficiencies that might jeopardize compliance. The system also offers user-friendly dashboard, drill-down, and scheduling capabilities.
- Revision control: MasterControl training solutions provide revision control to guarantee that only the most current training courses are available and a traceable history of revisions.
- Random examination questions: Training courses that require examinations can be preconfigured to pull questions at random from a pool of preset questions. This feature ensures that users who have failed previous exams won’t get the same questions in the same order when if the exam is administered again.
- Training verification options: For basic training courses that don't require verification, tasks can be configured to bypass verification altogether. This streamlines training processes and reduces the burden on supervisors, preventing them from wasting time on unnecessary verification.
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.