The global pharmaceutical market is expected to grow to $632.71 billion in 2025, fueled by precision medicine, increased research and development investments, and regulatory support. However, with this expansion comes new challenges—many of which eLearning can help address. Biotechnology companies are looking for scalable and flexible solutions that provide cost-effective training, support global efforts, and drive innovation and operational excellence while simultaneously meeting compliance.
Dokeos LMS collaborates with biotech companies. This is to improve compliance, improve operational processes, and support ongoing innovation.
Why the Biotech Industry Needs an LMS
Biotech’s fast-paced growth presents challenges in both operations and compliance, including:
- Regulatory Compliance: Biotech companies must comply with strict regulations such as FDA 21 CFR Part 11, EU GMP Annex 1, and ISO standards. Regulatory non-compliance may result in financial penalties, damage to reputation, and potential patient safety issues.
- Complex training needs: Biotech employees require specialized training to stay up-to-date with changing regulations, Standard Operating Procedures (SOPs), and technological and medical advancements.
- Data security: Securing sensitive information—intellectual property, clinical trial results, and patient records—must be a priority for biotechs. Therefore, they must deploy advanced features to safeguard against breaches.
- Global operations: Many biotech companies operate globally, with employees who require training in varying local and internal regulations and different languages.
A validated learning management system (LMS) like Dokeos addresses those challenges by not only supplying you with the tools you need but also by partnering with your company to simplify compliance, drive innovation, and reach operational excellence.
Why Dokeos LMS is the Perfect Fit
Firstly, Dokeos is a validated, GxP-verified LMS, meaning that the system is specifically designed to operate and meet the needs of biotech companies. Here are a few ways, how our system standards out:
Compliance-driven design
Compliance is non-negotiable – which is why Dokeos has been built with compliance at our core. Our system ensures you are compliant with FDA 21 CFR Part 11, EU GMP Annex 1, HIPAA, and ISO standards. Our key compliance features include:
- Electronic signature management: verifies user identity during training, enhancing data integrity and accountability. This is your paper equivalent.
- System audit logs: Track and log all user activities to provide traceability and transparency during regulatory audits.
- Certification management: Automates certification tracking and renewal processes, ensuring that your employees consistently meet compliance requirements.
- Version Control: Tracks each version of compliance documents and offers “freezing modules & users.” This prevents editing of modules once in production and restricts editing and the removal of users in the database.
- Training record tracking: Generate individual training files and certificates and assign timestamps and authentication to these records.
Advanced security features
Protecting data is a top priority in biotech. Dokeos safeguards critical information with key security features such as:
- End-to-end encryption: Safeguards your sensitive data during transfer, protecting it against unauthorized access.
- Role-based access control: Limits access to sensitive data based on your employee’s roles.
- IT security testing and monitoring: We employ regular penetration testing, 24-7 monitoring, and self-hosting options to make sure you receive comprehensive data security.
- Third-party vendor assessments: We also evaluate and monitor any external integrations to reduce potential risks.
Scalable and customizable solutions
Your LMS must be able to scale with growing teams and their evolving training needs. It must also deliver standardized training across your global teams, ensuring compliance and consistency regardless of location. Dokeos LMS adapts to meet your needs with:
- Tailored training pathways: create and assign role-specific learning journeys for your employees, ensuring they receive the knowledge they need to perform their roles confidently.
- Integration capabilities: Our system seamlessly integrates with your QMS, HR tools, and CRM. Creating a consolidated and secure platform.
- Multilingual support: Deliver consistent and standardized training across your global teams regardless of their location and language.
- Scalability: Our system expands as your business grows, adapting to continuously meet your training and compliance needs.
Comprehensive training features
Dokeos LMS ensures regulatory compliance while optimizing employee’s training by:
- Interactive content creation: Create engaging content-rich modules, quizzes, and simulations tailored to real-world scenarios that your business may face.
- Virtual classrooms and webinars: Enable collaborative learning among temas through live online sessions and discussions.
- Survey and feedback tools: Improve training effectiveness and employee satisfaction with actionable insights from online surveys and polls.
- Automated training records and notifications: Ensure that your employees have real-time access to up-to-date records and certifications. By automating your training records, you improve your audit preparation.
Vendor expertise and support
With over two decades of experience, Dokeos provides expert guidance throughout implementation and beyond. Services such as CAPA optimization, validation planning, and regulatory training material development ensure your company remains audit-ready and compliant. Additionally, we provide further support with the following:
- System implementation assistance: Reive expert guidance during system setup and validation processes, making sure you are compliant from day one.
- Regulatory training materials: We have partnered with GxP Training, providing integration with over 80+ regulated and certified life science courses, ensuring your employees have access to the knowledge they need to remain compliant.
- Continuous support: We provide you with ongoing assistance to get the most out of our system while remaining audit-ready.
- Proactive compliance monitoring: Stay ahead of regulatory changes and guidelines with real-time updates and expert advice from our consulting team.
Transform your Training Compliance with Dokeos LMS
Dokeos LMS is tailored to meet the complex demands of life science companies, offering a validated, GxP-compliant platform that ensures seamless compliance with FDA, EMA, ICH, and ISO standards while optimizing training processes.
We offer you advanced features such as an integrated authoring tool (SCORM, HTML5, and LTI compatible) so you can confidently develop engaging and interactive training modules. Ensuring you remain compliant while upskilling your employees. Additionally, our system integrates with existing QMS and HR tools, providing a consolidated and secure system that streamlines workflows and protects sensitive data.
Furthermore, our system is completely scalable, including features to support your global operations, such as multilingual capabilities, ensuring you meet regional and international regulations.
Schedule a free trial or book a demo with one of our experts to see how we simplify compliance and support innovation and operational excellence.
