Subject – Implementing LMS System

The client provides clinical development, trial management, and pharmacovigilance services for top pharmaceutical and generics organizations, as well as small and mid-sized drug development companies. The company has over 1,800 employees, with its headquarters located in the United Kingdom. 

As a pharmaceutical company, the client needed an LMS system that would be validated and assist them in executing various business processes. These processes, among other things, are designed to help them maintain the appropriate quality of training and ensure that their staff is trained in a manner that complies with regulations. An essential aspect of their goal, particularly in smaller projects, was to streamline the reporting process. This would enable them to confirm that all individuals onboarded for a project had successfully completed the necessary exercises.

The client brought eConsulting on board for the implementation of two Cornerstone OnDemand modules, namely Core and LMS system for GxP. 

The customer chose eConsulting based on the recommendation from the software provider – Cornerstone OnDemand, which identified eConsulting as the top implementation partner for life-science areas with extensive experience in validation processes.

Scope of work

Step 1: We asked the customer to complete various questionnaires aimed at helping us understand their specific needs and preferences for utilizing the system.

Step 2: Our team requested crucial documents – the System Risk Assessment (SRA) and User Requirement Specification (URS), marking the commencement of the project.

Step 3: Business Process Alignment (BPA) initiative.

A Business Analyst Consultant from eConsulting conducted workshops with client’s team over several days, leading an inventory of their processes. Together, we defined how these processes would be implemented in the Cornerstone OnDemand system, resulting in the establishment of six distinct processes.

Step 4: Validation Workshop.

In cooperation with Cornerstone we introduced the customer to Cornerstone’s validated environment methodology and maintenance approach. During this workshop, we developed a responsibility matrix delineating individual roles, which resulted in a comprehensive report. This report served as the cornerstone for subsequent implementation decisions.

Step 5: Series of Discovery workshops to familiarize the client with Cornerstone’s functionalities.

These sessions delved into the User Requirement Specification, outlining functional and non-functional system requirements, and the System Risk Assessment, identifying anticipated risks and their values.

Step 6: Validation Plan, elucidating the system’s validation strategy, including legal and formal aspects, testing procedures, and deployment strategies.

Step 7: Implementation. Constructing prototypes to showcase how processes would unfold in the system. After prototype approval, our team proceeded to build the final configuration.

Step 8: A Proof Of Concept workshop. This workshop provided a comprehensive overview of all processes, categorized by different roles (e.g., end user, admin manager).

Step 9: User Acceptance Testing (UAT). Our team prepared and verified tests, conducted trials to confirm scenario readiness, and engaged their Quality Assurance team before handing over to the client for verification and final approval. The client’s testers were adequately prepared and guided through the testing process by the eConsulting team.

These tests served dual purposes – not only for functional validation but also as documented evidence to prove system validation. After the tests concluded with a positive outcome, we finalized the Validation Test Report. 

Step 10: Creation of a Configuration Workbook and delivery of the Admin Training tailored to client’s specific needs and system processes, concluding the successful implementation of the project.

The team consisted of 9 individuals, comprising a Project Manager, 3 Implementation consultants, an Integration & Implementation consultant, a Compliance Engagement Manager, a Business Process Analyst, a Business Leader, and a Business Development Manager.

Result

Following the completion of the project, the client opted to extend our collaboration. Currently, we are handling client’s CSOD Change Management Process, CSOD Incident Management Process, and CSOD Release Management Process. 

With a validated LMS system in place, the customer now has the ability to monitor who has been trained, when, and on what topics. This is crucial for them due to the regulatory requirements imposed on their clients.

Additionally, it enables them to promptly furnish auditors with confirmation that all individuals within their projects have undergone appropriate training. It proves to be an excellent tool for reporting and maintaining comprehensive records of these data points.

The client appreciated our extensive knowledge and experience in projects like Clinical Research & Operation, particularly in the thoughtful design of the system from that perspective. 

Additionally, the amiable and pleasant atmosphere has contributed significantly to the overall excellence of our collaboration.

During the advanced stage of LMS system implementation, a new project idea regarding specific functionality emerged within the client’s team. In this project, the customer is collaborating with eConsulting to leverage Cornerstone in a highly specific manner tailored to align with their unique process. The project is continuously evolving, and we are actively working together on its development.

If you require our assistance in the CSOD LMS implementation, get in touch with us.