So far, in 2024, there have been 100 medical device and radiation-emitting product recalls, highlighting the ongoing challenge medical device manufacturers face in maintaining device quality, safety, and efficacy post-approval. How do you prioritize quality throughout the supply chain? Through training records. Medical device companies must establish protocols to identify employee training requirements and to ensure that everyone is appropriately trained for those needs. These training records demonstrate to the FDA and other governing bodies that you have met the training requirements and guidelines that govern the industry.
Our quality experts have prepared this article to provide insights into effectively updating and managing your training records in line with regulatory requirements.
The Imperative of Training Records in Medical Device Manufacturing Compliance
For all medical device manufacturers, training is a regulatory requirement of the FDA and international governing bodies. For instance, FDA 21 CFR 820.25 requires all medical device manufacturers to show proof that their employees have the required background, education, training, and experience they need to perform their roles.
Another requirement that all medical device manufacturers need to comply with is the FDA 21 CFR part 11, which requires companies to have data security controls for all electronic records, and ISO 13485 certification outlines the data protection needed to maintain the integrity and confidentiality of training records.
Thus, in order to meet these FDA (and ISO) requirements, it is essential to focus on the following two critical aspects:
- Maintaining accurate training records.
- Adopting a continuous education program.
Frequent Obstacles in Managing Training Records
Medical device manufacturers may face the following challenges in managing their training records, including elements such as:
- Handling large amounts of data across facilities: Running numerous facilities or departments with large amounts of training data requires time-consuming data consolidation into a single system.
- Updating training materials with regulatory changes: Medical technological advancements and regulatory evolutions go hand-in-hand to protect patient safety. When new regulations are published, training managers must add them to training materials in real time.
- Avoiding errors in manual record-keeping: Traditional record-keeping typically depends on manual processes prone to human errors. This can result in entry mistakes and misfiled documents that may affect your data integrity and hold up compliance efforts.
In summary, these challenges can compromise your company’s data accuracy and completeness, potentially leading to compliance risks, audit failures, and a negative impact on your brand’s trustworthiness score—resulting in devastating consequences in a highly competitive industry.
5 Best Practices for Effectively Managing Training Records
To comply with the regulations highlighted above, you must be able to manage your training records effectively. Therefore, it is imperative to implement the following five best practices.
1. Centralized storage
Centralizing your training records in a centralized hub like a learning management system (LMS) like Dokeos LMS lets your employees–and stakeholders—easily access files and reports as needed. With Dokeos LMS, training data is consolidated (and combined) into a single point, reducing duplicated documents, simplifying retrieving records for audits and inspections as well as simplifying operational transparency.
2. Automation: The way to reduce manual errors
Automating training record management enhances operational efficiencies by reducing human error. Dokeos LMS includes automations that keep track of employee training progress and monitor regulatory updates, making sure your training records are always accurate and audit-ready.
3. Data security measures
Data security is paramount in the modern world. Not only do international regulatory standards mandate that robust security measures be implemented, but they are equally important in handling sensitive employee and company information safely. An LMS like Dokeos provides enterprise-grade security protocols, including encryption, role-based access controls, and two-factor authentication to protect records from internal or external breaches.
4. Routine compliance audits
Compliance audits provide insights into how well organizations comply with the required regulatory standards. Consequently, it is vital to conduct regular audits of your organization’s employee training records to determine to what extent they comply with these standards. An LMS like Dokeos includes comprehensive audit trails, detailed reports, and compliance tracking, simplifying routine compliance audits.
5. Data analytics for actionable insights
Actionable insights provide employees with information about employee training effectiveness. A learning management platform (like Dokeos LMS) comprises advanced analytics tools that allow employers to continually monitor training progress, identify knowledge and skills gaps, and optimize training strategies to ensure continuous improvement.
How Dokeos LMS Helps You Manage your Records
An LMS is not only vital to making sure your training records are compliant with industry standards, but it is also a valuable tool to help optimize training strategies and identify any knowledge and skill gaps.
Dokeos LMS allows medical device manufacturers to benefit from an FDA-compliant platform that offers advanced features to manage their training records with compliance and precision. Our platform makes sure that your company is fully aligned with FDA CFR 21 Part 11 and ISO 13485 standards by delivering automated tracking, individual training files with timestamps, authenticated audit reports, electronic signatures, and audit trail functions.
In summary, the Dokeos LMS ensures all employee training activities are fully auditable, traceable, and inspection-ready at any moment.
For Software-as-a-Medical Device (SaMD), we simplify software development, documentation, and regulatory compliance by making sure you have full traceability with ALCOA+, versioning, and GIT workflows.
Therefore, do you want to learn more about managing your training records?
Our partner, GxP-Training, offers an online GMP Documentation and Record Retention course that is CPD/CEU accredited and 21 CFR Part 11 compliant certification.
We help ensure your employees are compliant with regulations! Do you want to manage your training records with Dokeos LMS? Schedule your free trial today!
FAQs
Why are training records important in medical device manufacturing?
Training records (for employees) are critical in medical device manufacturing because they show that the manufacturer has complied with regulatory authorities. Accurate and up-to-date training records are crucial during audits and inspections to verify Good Practices (GxP) adherence.
