Merely complying with FDA (21 CFR Part 11) and ISO standards is not enough – it is the foundation of consistently delivering safe and effective medical devices while leading the field in innovation and trust. Are your training and quality management systems aligned to guarantee compliance?
Do you own (or manage) a medical device company looking to deliver ingenious training while complying with regulations? How can you guarantee that all your electronic records and signatures meet regulatory standards?
With the right tools—or software—you can navigate changing regulations and quality standards, making a significant difference to your organization’s workflows. Recent changes from the FDA, including the January 31 amendment aligning current good manufacturing practice (CGMP) requirements to the Quality System (QS) Regulation under 21 CFR 820, accentuate the push for global harmonization in quality management systems.
In this article, our quality experts detail 10 cutting-edge ways our system empowers you to overcome compliance challenges in delivering training.
10 Ways Dokeos Ensures 21 CFR Part 11 Compliance
Complying with 21 CFR Part 11 and ISO 13845 may seem overwhelming. These regulations not only govern electronic record keeping but also require continuous employee training. Additionally, proof of your compliance – audit trails – must be readily available for inspection. Here’s how Dokeos LMS, a purpose-built learning management system, simplifies compliance and operational efficiency:
1. A validated learning management system
Dokeos LMS is a fully validated e-learning platform that meets the strict standards of the FDA and ISO. What is a validated LMS? Why do I need one for my company? When a system is validated, it means that the system operates in a manner that is reliable, safe, and in accordance with regulations (21 CFR 11.10 (a)).
A validated system is also necessary if your electronic system manages processes governed by ISO 13485, EU GMP, and 21 CFR Part 820.
Combined with a user-friendly interface, you have a platform that simplifies compliance and prioritizes seamless training delivery.
2. Secure electronic records and signatures
We have built tamper-proof electronic records and secure e-signatures into the system, making sure you preserve data integrity and meet compliance. Our system automatically logs and timestamps all actions, complying with 21 CFR 11.10 (e). We also prevent signatures and records from being falsified and copies with linked signatures to signee’s accounts (section 11.70 (a).
Additional features such as “authors” validate content and course completion using their authenticated signatures, which is associated with 21 CFR 11.50.
3. Comprehensive audit trails
Maintaining detailed audit trails is required for compliance with 21 CFR Part 11. Dokeos keeps extensive system logs that track all your events. Our audit reports fulfill the requirements of section 11.50 (a), recording the names of signees, logs, and timestamps.
Moreover, our team of experts prepares you for more than 15 audit types, reducing any compliance gaps and risks.
4. Role-specific training and certification
You need to make sure that all relevant personnel are not only trained on requirements but actually understand their role in handling records in accordance with 21 CFR 11.11(i). Our structured training journeys make it easy to make sure that the right personnel revive the knowledge tailored to their roles in maintaining compliance.
Our system ensures compliance with training records (under 21 CFR Part 11) with individual training files with timestamps and authenticated audit-ready user reports. Additionally,in accordance with section 11.10 (b), we export training reports in PDF and Excel format with time stamps and the identity of the individual requesting the report.
5. Integration with quality management system (QMS)
Do you have an existing quality management system (QMS)? Our system integrates effortlessly with your QMS to provide a single and secure platform. This meshing of systems consolidates your training records and quality management documents, enabling traceability and compliance with both ISO, EMA, and FDA standards.
If you do not have a QMS for your medical device manufacturing company, our compliance experts can help you select and implement the right system.
6. Automated compliance tracking
Gone are the days of manual errors and missed deadlines. Our platform automates vital compliance workflows, including training assignments, certificates, and refresher schedules. Additionally, any data that is deleted or modified is automatically logged and timestamped in accordance with Section 11.10 (e).
7. Customizable training modules
We provide you with the tools to create training modules tailored to your compliance and operational needs. Cutting-edge features like double-bling quizzes, real-world scenarios, and interactive modules improve knowledge retention and assessment accuracy. Ensuring you meet compliance standards while providing your employees with the knowledge they need to perform tasks confidently.
Our system enforces a sequence of events in each course module (Section 11.10 (f)), requiring employees to verify the completion of each section with their e-signature.
8. Real-time analytics and reporting
To make sure your compliance strategies work and continue to get better, you need access to advanced analytical tools. Allowing you to track completion rates, monitor training effectiveness, and pinpoint knowledge gaps.
To ensure only authorized individuals have access to electronic records (section 11.10 (d)), our allows HR to grant access to individuals via distributed roles. Furthermore, system features like freezing modules and restricting user edits make sure your training materials are consistent and accurate. Admin may approve or revoke access to these features at any given time.
9. Data Security
Apart from providing two-factor authentication, we ensure compliance with Section 11.200 (a) (1) by requiring all users to create a secure password that cannot be deciphered through brute-force hacks. Our system automatically tells the user when they need to update their passwords in accordance with Section 11.300 (a) (b). To safeguard from hacking attempts, our system blocks users after a set number of attempts and reports the incident to the administrator.
Additionally, the LMS will automatically sign inactive users out of the system after three hours.
To protect electronic signatures (section 11.200 (a) (3)), the global administrator is the only user who has access to another account.
10. Expert support and consulting
Dokeos LMS doesn’t just provide you with another tool – it delivers a partnership that is just as invested in your success as you are. We provide compliance support not limited to Computerized System Validation (CSV), audit simulations, and compliance strategy development. With over 14 years of experience spanning FDA, ISO, and EMA regulations, we help you stay ahead in the complex regulatory landscape.
Dokeos LMS: Your Partner for 21 CFR Part 11 and ISO 13485 Compliance
Dokeos understands that compliance is no small task. We have outlined 10 ways our system helps make sure you are compliant with both 21 CFR Part 11 and ISO 13485 requirements – ranging from a validated system and secure electronic records to customizable training paths and real time analytics.
Our system not only helps you comply with regulations but also promotes operational excellence. Features such as automation, role-specific training, comprehensive reporting, and generated timestamps make sure that your business is always inspection-ready. Furthermore, our focus on precision and flexibility provides the tools you need to navigate the complex compliance journey and, at the same time, prioritize innovation.
Let Dokeos LMS partner with you to make compliance simple. Schedule a free trial today, or schedule a demo with one of our experts.
FAQs
What Makes 21 CFR Part 11 and ISO 13485 Compliance Essential?
Compliance with 21 CFR Part 11 and ISO 13485 is crucial for organizations in regulated industries such as pharmaceutical and medical device manufacturing.
- 21 CFR Part 11 (FDA regulation) ensures the integrity, security, and traceability of electronic records and signatures, making them legally compliant and audit-ready.
- ISO 13845 (International standard) provides a framework for quality management systems (QMS) in medical device manufacturing, ensuring product consistency, risk management, and regulatory adherence.
Following these standards helps companies maintain regulatory approval, ensure data accuracy, improve product quality, and avoid no-compliance penalties—while prioritizing patient safety and operational efficiency.
