There is no good reason to spend more money and add one more layer of infrastructure. Strategic moves do not bear on tools but on defining and reaching narrowed down objectives. The objectives a LMS, such as Dokeos, can help to reach encompass:
- Aligning sales with branding and corporate sales objectives.
- Complying with government regulations through employees training and certification (HIPAA, GxP, ISO, etc.).
- Helping clients become familiar with products and services.
- Ensuring a seamless turnover among employees (Knowledge Management).
Of course, your objectives can combine two or more of these objectives. But let’s imagine you got only one and the one is GxP compliance. You are a Pharmaceutical Company, a Clinical Research company or a Contract Research Organization involved in clinical trials, drugs manufacturing, etc. Your company is, consequently, subject to FDA or EMA GxP regulation, and you have already started validating your processes along these lines [GAMP5, Good Clinical Practices, Audit Trails and paper-equivalence traceability (usually labelled 21 CFR PART 11 following to the applicable FDA regulation book chapter)].
This leads to a series of consequences :
- Training evaluation has to be validated and logged in terms of exam version and employee identity authentication.
- The company should edit and distribute a Quality Manual and a set of SOPs (Standard Operating Procedures) and have corresponding employees commit a minima on reading and understanding these documents.
- Any electronic system (CRM, LMS, Emailing, etc.) is subject to FDA auditing along 21 CFR PART 11 and has to be validated. Each employee should be trained on how to use the electronic systems so as to comply wityh FDA regulations.
- Processes should all be traced and logged. This includes not only the learning and the examination process but also the authoring of quizzes and the versioning of training material. This is both a reason to use a LMS that forces documents versioning and the corresponding necessity to validate the LMS itself.
In a perfect world, relying on a LMS should facilitate all this, as long as the LMS is GxP-compliant. This means the selected LMS :
- Has a versioning mode.
- Provides audit trails and a change log.
- Is validated by your company or we can take advantage of it being validated by a company similar in terms of requirements.
- Forces eSign (Electronic Signature) after reading SOP documents or during the Examination process. eSign means simply that users need to login twice so as to confirm their identity.