Subject – Implementing LMS System

Our client was a pharmaceutical company that provides services in clinical development, research management, and pharmacovigilance for leading pharmaceutical organizations, as well as small and medium-sized companies involved in drug development. The company employs over 1800 staff, with its headquarters located in the United Kingdom.

The client expressed a need for an LMS system that can be validated and will help the organization in carrying out various business processes. The goal of these processes is to maintain high-quality training and ensure that employees are trained in accordance with current regulations. A key aspect, especially for smaller projects, was to streamline the reporting process, which would allow verification that all individuals assigned to the project have successfully completed the required training.

eConsulting was selected to execute this project based on the recommendation of the software provider, Cornerstone OnDemand, who identified us as the best implementation partner in the life sciences sector, with extensive experience in validation processes.

Our task was to implement two modules of Cornerstone OnDemand: the Core system and LMS for GxP.

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

After the project was completed, the client decided to continue our collaboration. We are currently handling the processes of change management, incident management, and release management within the Cornerstone OnDemand (CSOD) system.

Thanks to the validated LMS system, the client can now monitor who has been trained, when, and on what topics, which is crucial due to the regulatory requirements of their industry. The system also allows for the quick provision of confirmations to auditors that all individuals involved in projects have completed the necessary training, making it an excellent tool for reporting and maintaining comprehensive records.

During the advanced stage of implementing the LMS system, the client’s team developed a new concept for a specific functionality. The client intends to use Cornerstone in a unique way, tailoring it to their specific process. The project continues to evolve, and we are actively collaborating on its development.

As eConsulting, we have been recognized for our extensive knowledge and experience in projects such as Clinical Research & Operation, as well as the friendly and pleasant atmosphere of our collaboration, which has significantly impacted overall satisfaction.

We are proud of our achievements so far and are delighted that our support has contributed to the client’s success. If you need our assistance in implementing the CSOD LMS or have any questions about our services, get in touch with us. We would be happy to help you achieve your goals and support the growth of your organization.