Pharmaceutical Companies, Life Science Services Organizations and Contract Research Organizations have to comply with the american Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulations.
FDA and EMA audit these organizations on a regular basis at various stages of the process : laboratory practice, clinical practice, manufacturing, transportation etc.
Electronic systems like Documentation Systems, Backup Systems and Learning Management Systems have been addressed in the 80's with a dedicated set of rules labelled FDA 21 CFR PART 11.
The concept of this regulation is to ensure electronic systems are as reliable as old paper-based processes. Since electronic systems offer various possibilities to cheat with data (it is easy to delete, replace and edit data), dedicated features are required to demonstrate FDA auditors that data was not deleted, replaced or edited and that the authenticity, authentication and date of any record can be established without ambiguity.
Dokeos was historically the first LMS to comply with FDA 21 CFR PART 11 in 2013 due to a collaboration with Ipsen Laboratories and Patrick Jonvel, Global Manufacturing Quality Manager and FDA expert.
Dokeos LMS offers a complete set of features for:
- Exams versioning and version freezing
- Electronic Signature of employees
- Date and authentication stamps on any print export generated by the system
- Blocking the deletion, replacement and editing of any set of data for a dedicated set of employees (admins, authors, employees...)
Dokeos LMS has been approved for its ability to allow Ipsen comply with FDA audits on systems and the relevance of its reporting features for Life Science companies. In particular the Individual Training Files that fit with auditors expectations.
Dokeos is an effective management system designed for high consequences industries.
Thomas De Praetere, CEO at Dokeos.
Learn how other pharma companies benefit of Dokeos being FDA 21 CFR PART 11 compliant.