Effective Training Compliance Management with a Pharma Learning Management System

Client:

Category:

Service Case Study

Industry:

Pharmaceuticals

PROBLEM STATEMENT

Introduction

For obvious quality control necessities, pharmaceutical is a regulated business. Academics define Pharmaceutical regulations as “the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information”(Lezotre, 2013; Rägo and Santoso, 2008). As the training process comes within the purview of these regulations, the Learning Management System (LMS) effective for the industry needs to have specific features to address the requirement.

When they approached Tenneo (formerly G-Cube LMS) to find a digital learning solution, they had specific need

An agile & robust learning platform to enhance the competence of sales staff at the dealerships.
A learning solution which can be scalable, cloud-based, and gamification friendly to engage the learners.
Easy access to various formats of learning contents and a tracking mechanism for training delivery and outcome.
Ability to provide elearning and blended learning that makes workforce knowledge ready quickly with new products and features.

Scope of Work

Collaboration with multiple clients from the Pharma industry, gave us the opportunity to study the definite needs of industry and training compliance is a top concern. Pharma companies have to take care of both ‘People Compliance’ – who can do the job, and also ‘Process Compliance’ – how to do the job. Other than regulatory body guidelines, they also have internal SOPs to maintain including the audit trail for the entire mechanism. With careful evaluation, it was found out that there is a definite need for automation of Training Compliance by customizing the Learning Management System to achieve the 3 major goals in this complex compliance environment.

Challenges:

During the industry exploration, it emerged that in 2019-2020 an average of 400 organizations have received warnings from the FDA for non-compliance related to creating or following SOPs and problems with record keeping. This excludes the internal best practices they must maintain in the process. Failure in this situation not only means fine levied by statutory bodies likes FDA but endangering human lives. Thus, the challenges here are not just complicated but critical.

Complicated and Repeatedly Changed SOPs
No System to Track Training Non-Compliance
Lack of Audit Trail in Prescribed Format

How can a Pharma Learning Management System solve these challenges?

Automated Workflows for Training Assignment
Simplified Process of Compliance
Prescribed Audit Trail Management

Impact

To create an effective compliance management strategy, one has to start with identifying the job that needs to be done and further breaking it down to the multiple elements that are the various parts of that job’s process including the individual doing it.

18% reduction of non-compliance resulting in reduced penalties.
47% reduction of admin effort.
18% reduction of audit cycles.
The long-term impact of the system will be saving up to 2 FTE i.e full-time equivalent for the client.
20% reduction in compliance training cost.
50-60% savings in Document Management System renewal cost.
The employees are no more dependent on the managers to receive notification for new training or SOP change.