Can a LMS offer a FDA compliant solution ?

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 performed appropriate qualification to demonstrate that system features fit with current regulatory expectations regarding the use of Dokeos LMS solution in the highly regulated context of Pharmaceutical industry.

21 CFR PART 11 applied to training !

« Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFRPart 11 Section 11.1 (a))»

Practically, the company needs the following training records:

  • For each employee, we need a record of diplomas (archived PDFs)
  • Training followed (a yes/no is enough)
  • Skills validation (certificates)

 

Download the case and learn more about GxP compliance in e-learning

Thomas De Praetere

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