Integration Capable LMS for Better Compliance in Pharma

Be it the case of 429 inadequate standard operating procedures and document controls observation made by US FDA in 2018 or the fact that 25% of warnings made by US Office of Manufacturing Quality were for failure in maintaining written procedures and records, the cost of non-compliance is staggering, especially since Pharma operations are vast, at large scale and often involve contractual partners. Frowning at the cost of maintaining a team for document management and training personnel on SOP changes, doesn’t help. What helps is an LMS tailor-made for the needs of the pharma industry!

The very clear trend that has emerged from our research is that quality management (QMS) requires a robust document management system (DMS), and for every change in standard operating procedures, trainings must be rolled out to all impacted roles.

The good news is that these costs can be managed and reduced! The solution lies in integrating the QMS and DMS with a robust LMS. Here’s how.

Automated Triggers for SOP Changes and Related Training

A good DMS will have built-in change management processes for information dissemination when a change occurs. Linking the DMS to an LMS will also ensure that change training can be created at the time of making changes to the SOP. Once the change is finalized and approved all roles linked in the LMS to that SOP, will receive the change training notification, link and a completion date.

Reduced Cost of Training

With the training being online, and through an interactive medium like LMS, there is no need to invest in training resources like facilitators, travel, venue, and operational downtime. These change trainings can be undertaken anywhere, at the trainee’s convenience.

QMS Updates After Successful Training Completion

Successful training completion tracked by the LMS, can be fed back into the QMS so that people remain compliant to regulated processes, which can in-turn ensure lesser non-compliance issues cropping up during the quality check process.

Record Maintenance for Change Management and Change Training

For avoiding observations or warnings around document control and change training, it is very important for a Pharma company to maintain records for every change and the resulting training. Integrating the DMS with the LMS can help with both, by maintaining an automated record of the entire change management process and resulting update trainings.

Dashboards for Monitoring Trained Personnel

Every time a change training is triggered by the LMS, a dashboard can be viewed showing the number of affected roles, training completion status and can also trigger escalations through the hierarchy in case the LMS is also linked to the HR systems. These integrations allow for leadership, quality, compliance, and legal teams to keep tab on compliance status and take proactive steps to ensure that compliance is maintained.

In Pharma, scrutiny from regulatory bodies is high and therefore requires an extremely stringent approach to change management, training, and compliance. Choosing an integration capable LMS can go a long way in helping manage costs and stay compliant.

At GCube, we have 20 years of experience and 80+ industry awards in learning technologies; and would love to hear your thoughts, queries, and suggestions. Please do write to us.