CASE STUDY How we assisted our GxP customer in integrating project roles and training

Integrating project roles and training

Subject

Our client is a prominent global Contract Research Organization (CRO) known for its expertise in overseeing clinical trials across diverse therapeutic areas. Renowned for its commitment to ensuring timely project delivery and consistent patient enrollment, this client invests significantly in accurate feasibility assessments, involving medical professionals to predict study timelines effectively. Supported by a committed team of over 2,700 professionals, the client works passionately across 60+ countries.

The client grappled with a decentralized training management system, storing training-related data in disparate ways. Their primary formal requirement was to centralize this data for better management, seeking a unified platform to efficiently oversee and manage it.

They aimed to meticulously track their projects and exert significant influence while simplifying project management. Projects were intricately linked to specific roles within their organization, dictating training needs for participants. This demanded a stringent, validated environment where individuals had to undergo training. Verification of training completion was crucial, especially in scenarios such as audits necessitating proof of participants’ completed training.

Therefore, the client desired the ability to track who belonged to which process/project and what specific requirements existed within each. They had three main objectives:

  1. Centralization: They wanted all this GxP information consolidated into one repository, eliminating scattered archives.
  2. Accessibility: Easy access to this centralized GxP information was crucial for seamless management.
  3. Simplified management: The client sought an intuitive and organic system to manage these GxP aspects efficiently. For instance, whenever a new project commenced, they wanted a simpler way to manage individuals and have documented proof of all required training completed by process participants.

training management system

The challenge lay in creating a streamlined system that catered to these multifaceted needs, integrating training requirements with project roles, and ensuring accessibility and simplicity in managing this amalgamated data effectively.

The customer chose eConsulting for the implementation of the Cornerstone OnDemand LMS and Core modules because of our expertise and extensive experience in validation processes. Being a prominent competency center for validated CSOD, our team’s proven track record and specialized skills aligned perfectly with the client’s needs.

Scope of work

We initiated the initial phase of GxP CSOD implementation, Intelligence Start, where we sent various questionnaires. Concerning the LMS, the implementation always involves the Core module – the system’s framework. Thus, two modules were implemented: Core and LMS.

Initially, we sent the client various questionnaires with diverse questions allowing us to subtly determine key decisions that would later impact the system.

Later on, pivotal documents for us were requested – the System Risk Assessment (SRA) and User Requirement Specification (URS). This was followed by a kick-off. At this stage, the client was to provide us with scenarios and process descriptions. However, the client lacked detailed descriptions, so we provided an additional service – Business Process Alignment (BPA). During the BPA, we assisted the client in creating processes to maximize the benefits derived from it.

We conducted the BPA before the kick-off, and then proceeded with the implementation. 

In the meantime, we also conducted a Validation Workshop, which was a critical session outlining Cornerstone’s validated environment methodology and maintenance approach. The Validation Workshop, consisting of 5 sessions lasting 3 hours each, was conducted jointly by Cornerstone OnDemand and the eConsulting team specifically for the client. By the second or third session of Validation Workshop, client input and feedback were expected, involving discussions to establish a responsibility matrix outlining individual roles. Subsequent review and discussion of this matrix ensured mutual alignment and understanding. The outcome resulted in a comprehensive report or definitive agreements, forming the basis for subsequent implementation decisions.

Later we conducted several Discovery workshops, introducing the client to Cornerstone’s functionalities (rules, schemas etc.). These sessions involved exploring the User Requirement Specification, detailing the client’s functional and non-functional system requirements, and the System Risk Assessment, which outlined anticipated risks and their values. 

Around the same time, we developed the Validation Plan, outlining the system’s validation strategy, including its legal and formal aspects, testing procedures, and deployment strategies. This comprehensive plan acted as the cornerstone, dictating the strategy for all related activities, specifying responsibilities and timelines. Subsequently, the client reviewed the Validation Plan, aligning it with their security policies and protocols. 

During this period, we undertook separate technical projects for the client: Single Sign-On (SSO) and MS Teams Integration. The MS Teams Integration specifically aimed to facilitate live training sessions, particularly beneficial during the Covid era. This integration streamlined session management, allowing participant sign-ups, real-time monitoring of attendance and duration, and simplified post-training data handling.

Later we entered the Proof of Concept stage, showcasing the system’s functionality using mockups and refining all aspects. The client was highly satisfied with the POC, providing extremely positive feedback without any comments.

Proof of concept cornerstone

Following several months of work, the validation phase commenced. We prepared the Configuration Workbook and planned and executed IQ and OQ tests, covering both modular functionalities and integrations. Each integration required additional documentation in the form of Design Specification outlining the integration settings.

Subsequently, we conducted OQ tests and obtained client approval of the results. We then prepared and verified reports. We developed the Risk Responsibility Matrix, linking the Functional Specification with the Risk Matrix, which formed a critical part of the implementation. 

Before User Acceptance Testing (UAT), we conducted Admin Training tailored to the client’s needs and system processes. We defined the training scope for various user groups based on our knowledge of the client and their requirements. Admin Training spanned 16 hours, conducted as workshops to familiarize admins with the system effectively.

Due to the lengthy nature of the entire process, Cornerstone released two new releases in the interim. Given the validated process, the entire Release Management Process, including validation activities, testing, thorough documentation, and assessing functionality in the client’s environment, was involved. Consequently, we needed to cover and integrate both these new releases into the documentation.

Result

The implementation lasted for 12 months. It had to be adjusted according to the pace and capabilities desired by the client. In the project, a team of 9 members actively participated, with an additional 3 individuals specifically dedicated to writing test scripts on our side.

The continued collaboration stands as a clear testament to the client’s high level of satisfaction and contentment with our services. The client highly appreciated our experience within a parallel business domain. This enabled us to guide and support them throughout the process, offering invaluable insights to enhance their operations. 

Our GxP implementation significantly bolstered and simplified the client’s oversight of ensuring completion of all required trainings for specific roles. Through tailored adjustments and streamlined processes within the system, our solution enabled effortless verification of training completion and facilitated the addition of new courses when needed. Additionally, by introducing a range of roles that catered to the client’s business needs, we effectively distributed and managed work responsibilities, avoiding overburdening any single individual. Cornerstone also offered the client a means to manage smaller teams with ease. This flexibility allowed them to create, oversee, and verify numerous smaller teams—an essential feature highly valued by our client.


Explore how we can tailor solutions for your unique business needs and streamline your operations effectively: https://shop.econsulting.co/validation-services

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