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Compliance of the GxP regulations for non-automated training curricula\program (without EDMS integration)

Galactic 2
Galactic 2
0 Kudos

Dear Community,

According to our implementation process of validated SaaS LMS, we are curious about is the process would be validated LMS process if there will be of program (curricula) creation manually (item creation and profile assignment by the administrator). Has anybody such case?

We have some difficulties at this moment to integrate SOPs from EDMS, so is the plan to create curricula (programs) with the help of LMS Admin interface. Otherwise, there are some concerns from the business that it would be a breach of the regulatory requirements - EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (, more detailed paragraph 2.11:

2.11 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programs should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.

Please share your experience in the process of curricula (program) approval in LMS according to the regulatory requirements?