In GxP-compliant environments, the importance of having a skilled and reliable workforce cannot be overstated. Maintaining employee training and competence records is not a choice but a mandate in the highly regulated Life Sciences industry.
In our industry, researchers and operators are constantly developing, communicating, and updating life-saving knowledge and compliance procedures. That’s why Quality training is a crucial aspect of the Life Sciences. Employees whose training is up-to-date can be trusted to help steer your company toward its long-term goals. Furthermore, since your company’s safety and Quality standards are not static but must be continually updated with the changing best practices of the industry, employee training is even more vital for successful propagation of the best practices.
Using software for employee training speeds up the training process, automates time-consuming tasks such as training reminders, and simplifies training assessment. Furthermore, software-based training can improve transparency of employee competencies. It helps you identify employees who need training – or retraining – based on their periodic assessments. You can also align and integrate employee key performance indicators based on what trainings they receive. Employees can also access training materials remotely without having to leave their (home) office. And you can be 100% sure that your employees have all the information they need to complete their work.
General Training Requirements
There are several regulations that detect the training requirements in the Life Sciences industry. For example, the FDA Quality System Regulation (QSR), also known as 21 CFR Part 820, states medical device manufacturers are required to ensure employee training and competence as follows:
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Training Program ( §820.25 ): Medical device manufacturers must establish and maintain a formal training program. This program should ensure that all personnel involved in activities that could affect the Quality of the finished medical device are trained appropriately.
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Job Descriptions and Qualifications ( §820.25 ): Regulation requires that job descriptions are prepared for each position that affects the Quality of the produced device. Personnel must have the necessary education, background, training, and experience to perform their assigned tasks.
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Training Records ( §820.25 (b) ): QSR mandates that medical device manufacturers maintain training records for all employees. These records should include the dates of training, the type of training, and the individuals trained.
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Changes in Procedures ( §820.25 (b) ): Whenever there is a change in methods or procedures that affect the Quality of the device, employees must be made aware of the change through appropriate training, and the training records should reflect this.
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Documented Training ( §820.100 (a) (1) ): For certain critical tasks or operations, QSR specifically requires that personnel are trained, and this training must be documented.
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Quality System Training ( §820.25 (a) ): Manufacturers must ensure that employees are trained on the requirements of the Quality system regulation and their respective roles within it.
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Corrective and Preventive Actions ( §820.100 ): Personnel involved in implementing corrective and preventive actions must be trained appropriately to address and resolve Quality-related issues.
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Design Controls ( §820.30 (g) ): Employees involved in design and development activities must have the necessary training to perform their roles effectively and ensure compliance with design control requirements.
Apart from QSR, ISO 13485:2016 also places a significant emphasis on training and competence to ensure that personnel possess the necessary skills and knowledge to perform their roles effectively. The relevant training and competence requirements under ISO 13485:2016 include:
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General Training Requirements ( Clause 6.2.2 ): The standard requires the organization to identify the necessary competence for personnel performing work that affects product Quality and implement training programs to ensure their competence. The organization must also evaluate the effectiveness of these training programs.
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Competence, Awareness, and Training ( Clause 7.2 ): This clause specifies that the organization must ensure all personnel performing activities affecting product Quality are competent based on their education, training, skills, and experience. The organization needs to maintain records of personnel competence and provide training or take other actions to achieve the necessary competence levels.
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Awareness ( Clause 7.3 ): ISO 13485:2016 requires the organization to ensure that personnel are aware of the relevance and importance of their activities and how they contribute to achieving Quality objectives and compliance with regulatory requirements.
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Documented Training Procedures ( Clause 7.2.2 ): The organization must establish documented procedures for identifying training needs, providing necessary training, and evaluating the effectiveness of the training provided.
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Verification of Competence ( Clause 6.2.2, Clause 7.2.2 ): The standard requires the organization to assess the effectiveness of the training provided, including verification of personnel competence.
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Special Competence ( Clause 6.2.2 ): For specific roles that require special competence, such as personnel involved in product design and development, the organization must identify the necessary competencies and ensure that personnel possess them.
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Monitoring and Measurement of Processes ( Clause 8.2.3 ): The organization must establish criteria for evaluating the effectiveness of training and competence, and it should monitor and measure these criteria to ensure ongoing compliance.
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Records of Training and Competence ( Clause 4.2.4, Clause 7.2.2 ): ISO 13485:2016 mandates the maintenance of records of training, skills, experience, and qualifications for all personnel involved in activities that could affect the Quality of medical devices.
How to Simplify Training
One of the easiest ways to efficiently manage training and competence requirements in GxP environment is to automate your training management. An automated training system is a computerized training system in which users are automatically assigned to their training based on their job roles. This automated training management software also provides dashboards as visual aids for training managers and Quality Assurance professionals to monitor the progress of all trainees in real-time. The training management software can also be used to automate required retraining reminders whenever the training material is updated or periodic retraining is due for staff. Finally, automated training management also facilitates assignments evaluation process for you.
The Value of Automated Training
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With automated training, Quality Assurance professionals can use their time more efficiently by building a robust Quality Management System, since they no longer have to follow up with individual employees for pending trainings, training evaluations, and retraining reminders.
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Employees can independently identify the trainings applicable to their job role and spot their own training gaps.
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Every employee can stay up-to-date on the latest knowledge because every trainee has access to the relevant training materials 24/7.
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You are better prepared for GxP audits since you have access to all training records at your fingertips. This helps you quickly respond to the auditor’s questions.
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Automated training management systems are easier to scale than conventional systems, as any number of employees can access the training material at the same time from any location.
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Automated training systems are also more flexible and adoptable to organizational structure changes or business processes. All you need to do is update your training management system with the latest organizational structure or business processes, and the training management software will swiftly automate and distribute everything.
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Automated training platforms offer interactive and engaging content, such as quizzes, simulations, and multimedia assets, which can enhance employee engagement and improve knowledge retention.
Top 6 Tips to Automate Employee Training
Now that you are convinced you need an automated training management solution for improved productivity, here are our best tips to help you embrace the change.
Make an Organizational Chart
An organizational chart visually depicts the hierarchical structure of your organization, including departments, teams, and reporting relationships. Having a clear and updated organizational chart is essential for implementing automated training because it helps you identify key stakeholders, decision-makers, and individuals responsible for various training processes. This chart ensures the right people are involved in planning, implementing, and overseeing training initiatives.
Define Business Processes
Clearly define your organization’s business processes and workflows that relate to training. Identify how training needs are identified, approved, scheduled, delivered, and evaluated. This step ensures that the automated training management solution aligns with your existing processes and addresses any inefficiencies or gaps that need improvement.
Define Job Roles
Define and categorize job roles in your organization. This helps you tailor training content to specific roles, ensuring that employees receive relevant and targeted training. Each job role may require a different set of skills and knowledge, and the automated system can assign appropriate training modules based on these roles.
Digitize Training Materials
Gather and organize training materials such as documents, videos, presentations, and interactive content. Digitize these materials and ensure they are easily accessible within the automated training management system. This central repository of training content will be crucial for delivering consistent and standardized training across your organization.
Create Engaging Training Evaluations
Develop engaging and interactive training evaluations and assessments to measure the effectiveness of the training. These evaluations can include quizzes, tests, simulations, and practical exercises. The automated system can track employees’ performance and provide instant feedback, helping them reinforce their learning and address any areas of weakness.
Define Retraining Periods
Determine the frequency at which employees should undergo retraining or refresher courses. Depending on the nature of the training and the evolving needs of your organization, certain skills or knowledge may require periodic updates. Automated training management systems can schedule and notify employees about upcoming retraining sessions, ensuring that their knowledge remains current.
By following all of the above tips, you can effectively embrace change and implement an automated training management solution that aligns with your organization’s goals and enhances productivity! Remember: Successful implementation requires careful planning, collaboration with key stakeholders, and ongoing evaluation to ensure the system continues to meet your training needs and contribute to overall organizational success.
Conclusion
Embracing automated employee training is a transformative step toward enhanced productivity and regulatory compliance. By seamlessly integrating technology into training processes, your organization can empower your workforce with the knowledge and skills required to excel in the dynamic world of GxP compliance. As the Pharma 4.0 revolution is happening at full speed across the industry, the transition to automated training management offers you a strategic advantage, positioning organizations for sustainable success in the Life Sciences.
Discover how Scilife Training Management Software can help you automate your trainings and become GxP-compliant!
