Dokeos LMS seamlessly integrates FDA and EMA compliance to ensure accurate validation of employee competencies

Today’s pharmaceutical laboratories, research centers, clinical trial agencies, etc. are subject to the strict quality control requirement specifications and regulations of the U.S. Food and Drug Administration (FDA) and its European counterpart, the European Medicines Agency (EMA).

This has a significant impact on the industry’s employee training and competency assessment processes, affecting electronic data permanence, authenticity, and reliability. It also includes monitoring and capturing data on training and compliance, to allow traceability and validation by government agency auditors.

Seamless training and compliance validation

Dokeos is the only LMS on the market that seamlessly integrates all FDA and EMA requirements into a single, easy to manage system. That’s why it is the most used LMS system within the pharmaceutical and research industry for training, SOP, and compliance validation.

Fully compliant with FDA 21 CFR PART11, including electronic signature, versioning of reviews, etc.
Robust data security protection and encryption in preparation of a security audit.
Functionality geared specifically for the validation of SOPs.

Related business case

  • SOPs validation

    Beyond the simple “Seen and understood”, use the power of Dokeos EVALUATION to validate SOPs and skills and provide auditors with the Individual Training Files which will act as a legal proof of your validation through electronic signature and the possibility offered by Dokeos to save review versions.

  • Clinical analysis

    Dokeos EVALUATION rolls out a procedure by introducing questions and sub-questions to combine clinical reasoning with its iteration cycle. Don’t be content with multiple choice questionnaires that only check knowledge but not the ability to monitor a procedure or draw the right conclusion at the right time.

  • Recruitment through skills

    Use Dokeos as a HR tool to draft job descriptions and matching reviews. Dokeos will assist you with making the decision in your internal recruitment procedures by asking questions as simple as “give me the 5 best qualified individuals for the position of quality manufacturing manager”.

  • Certification

    Validate knowledge and base access to training upon success obtained during another training. A certificate is issued at the end of training depending on the criteria for success defined by the trainer. This certificate is automatically customized for each participant.

Business case

  • Cover of The Axea Solutions case

    The Axea Solutions case

    Axea Solutions is a successful company that specializes in providing online healthcare ICD-10 training. An opportunity arose for the company when the World Health Organization...

    Read more
  • Cover of GxP compliance and e-learning. The IPSEN case.

    GxP compliance and e-learning. The IPSEN case.

    Working with IPSEN, Dokeos has been challenged to adapt the LMS and make it compliant with GxP and especially FDA 21 CFR PART 11. IPSEN has...

    Read more
  • Cover of Toys ‘R’ Us and training the sales teams

    Toys ‘R’ Us and training the sales teams

    Download the new retail business case in partnership with Toys’R’Us. Toys ‘R’ Us manages 1500 stores worldwide for a turnover of $12 billion and has...

    Read more
  • Cover of Business case: evaluating reasoning

    Business case: evaluating reasoning

    I wouldn’t get onto a plane whose pilot had been tested only with multiple-choice tests. The fact is, if we are not careful, an MCQ...

    Read more
et, libero accumsan pulvinar vulputate, elementum felis vel, suscipit Curabitur leo