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Training Records

In regulated environments, a product's quality is attributed to the people who make them. For compliance purposes, their training and competence are considered key to maintaining high-quality products. More importantly, regulatory agencies require proof of employee training and competence, making training records indispensable.

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Product Information

Discover how MasterControl Training Records can manage your Training process, all while mitigating risk, improving speed-to-market, and generating ROI.

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Product Data Sheets
  • MasterControl Training™ is a robust and easy-to-use software application that streamlines a company's training program by connecting it to other quality processes and automating the routing, tracking, and follow-up of training tasks and even the grading of online exams. The system automatically notifies users about new training tasks and, upon completion, informs verifiers as well.
  • MasterControl Exams™, an optional add-on to the MasterControl Training™ module, automates the administration and grading of exams and also documents employee competencies. It offers a simple yet effective means of ensuring all employees have the competency to perform their job responsibilities and provides proof of that competency to regulatory bodies.
  • MasterControl Classes™ is an add-on to the MasterControl Training™ solution that simplifies the management of training classes. Users are able to conveniently schedule training resources (i.e., trainers, locations, and trainees) and administrators can specify the number of slots for various training classes and allow trainees to sign up for them.
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Consulting Services
  • MasterControl Quality and Compliance Consulting™ (QCC) offers intensive one- and two-day quality process workshops designed to help you stay one step ahead of even the most complex developments. The training is relevant regardless of the electronic quality management system (QMS) solution you use, or even if you do not have an automated system in place.

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Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
  • Tailored specifically for Quality Managers. Find out how closed-loop quality management can help you connect people, processes, and data across the value chain. Includes: 3 data sheets, 2 white papers, and much more.

Educational Materials

Get insider information about the most relevant issues in Training Records today, and how to navigate and overcome the complexities of FDA and ISO compliance.

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White Papers
  • This white paper defines the basis for global training guidelines, examines the associated challenges of meeting regulatory training requirements, and identifies common problems that can lead to quality system failures. It also presents a novel approach to tracking training programs that helps companies meet - and even exceed - regulatory guidelines.
  • This white paper identifies five common problems encountered by companies who attempt to manage training control processes without an automated system and shows how those difficulties can be overcome by implementing a more efficient training program. In addition, it points out the importance of connecting training with other quality processes and shows the value of advanced analytics and job code matrices.
Product Data Sheets
Case Study

Training Records in FDA, ISO Environments

Employee competence is highlighted in FDA regulations such as 21 CFR 211 (for pharmaceutical companies) and 21 CFR 820 (for medical device companies). Specifically, these regulations call for proper documentation and maintenance of training records for employees.

ISO regulations widely used throughout the world, such as ISO 9001 (for general manufacturers) and ISO 13485 (for medical device manufacturers), similarly emphasize the importance of maintaining personnel training records.

In both ISO and FDA environments, a training record for each employee whose job impacts product quality should cover such things as: tasks that the employee performs; proof that the employee has the proper skills and training for his or her job; and proof that the employee can perform his or her tasks competently.

Why Training Records are Important During Audits

Companies regulated by the FDA and those that adhere to ISO international standards typically undergo audits and inspections for compliance purposes and business reasons. The auditor or inspector is likely to scrutinize personnel training records during the inspection.

In the world of audit, there's a saying that if a training course is not documented, then it did not happen. In other words, you need training records to prove that training occurred and that your employees are properly trained. For audit purposes, you need to be able to track training tasks and training completion. Both of these aspects should be documented in your training records. This becomes especially critical when you have hundreds or thousands of employees in multiple locations. Exams and exam results are one way of showing to auditors that your employees are properly trained, so they should be an important part of your company's training records.

How MasterControl Can Help You Maintain Compliant Training Records

MasterControl Training automates paper-based and hybrid training processes, including documentation and maintenance of training records. It facilitates management of day-to-day training tasks by streamlining the training process. Here are some of its benefits and advantages:

  • Increased Efficiency: MasterControl automates routing, follow-up, notification, and escalation of training tasks, greatly increasing efficiency. It provides a centralized repository for all training records and documentation, making tracking and retrieval of documents faster and easier.
  • Improved Communication: Users get automatic notification about new training tasks or overdue tasks. Likewise, verifiers get automatic notification as soon as a user completes a task. MasterControl gives each user access to his or her training record, with a personalized folder showing past training, course due dates, and future training.
  • Connects with Other Quality Processes: MasterControl connects the training control process with other quality processes, such as document control, change control, CAPA, and audit management for a holistic approach to compliance. Any critical changes that affect training compliance will be addressed in a timely manner. For example, a CAPA that merits re-training will automatically trigger training tasks for the affected personnel as soon as the CAPA is resolved and the corresponding training course is approved. Once a user completes his or her re-training task, it is automatically included in the user's training record.

For More Information on Document Control Software Systems

For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.