Matt Jones - Chair, DIGIT Committee
Thanks for the question.
While a LMS may not seem to be under the jurisdiction of 21 CFR Part 11, you have to take into consideration the useage of the system, and the requirement of the predicate rule - in this case GCP/ GVP.
Those regulations require that staff are trained and conduct their roles by knowledge and experience and this should be documented. In the paper world this would be a signed reviewed paper training record.
In the electronic world this training record is held in the LMS, and you need to have controls around this, to ensure training is done on time, by the right person, the training is current, and the time taken to conduct the training is appropriate. Usually an LMS would have signature functionality and be able to produce a validated output for internal audit or imnspection purposes.
Therefore, the principles of 21 CFR Part 11 would need to be respected with regard to electronic records, open and closed systems, and electronic signatures (if used).
The important part is the linkage back to the predicate rules and ensuring that you comply with these, as 21 Part 11 is a framework that it used in direct combination with these.
Other regulations and guidance should also be taken into consideration when looking at the LMS especially if this is holding annual safety training completion data, which will be requested in any PV inspection.
I hope this helps
If you need any further guidance please don’t hesitate to reach out