CASE STUDY How eConsulting guided a pharma giant through CSOD Release Management Process

CSOD release

Subject

The client is a multinational pharmaceutical company headquartered in Paris, France. It specializes in the research, development, and manufacturing of drugs and vaccines for various medical conditions, including cancer, diabetes, and cardiovascular diseases. 

During the initial migration of smaller legacy Learning Management Systems (LMS) into Cornerstone, the client identified that one of the absorbed LMSs served departments operating within validated markets. It became evident that there was a need for validation in order to ensure controlled and secure processes for any changes or modifications. Due to this reason, in 2018, the client engaged the eConsulting team to oversee the release process, as proper execution of the release management was essential for maintaining validation within their operations.

Scope of work

We started by gathering crucial information about the client’s validation methods and system usage. This enabled us to execute the release management process covering the configuration and use cases. The project involved individuals from our CSOD department and Validation team members responsible for documentation. Regular status calls and pre-release meetings ensured alignment and roles definition. 

The validation, spanning approximately six months, focused on bringing the system to a state ensuring the client’s safety. 

After the project concluded, the client lacked their own trained staff capable of managing this process, which led them to entrust us with the responsibility of overseeing their Release Management and Patch Management in CSOD. This was due to the continuous updates from Cornerstone, necessitating a consistently validated state for their processes.

We also supported the client in the creation of regression tests. This set of tests aimed to be executed with every major change, including releases, to ensure that critical functionalities, essential to their operations, remained intact and unaffected by the release. Even if the release did not directly impact these functionalities – for instance, if the release involved entirely different aspects – these critical functionalities were still subjected to the tests to guarantee their continued proper functionality.

Over the years, we have been educating the client on best practices for Release Management and Patch Management. Together we handled several releases, shared our expertise and helped refine the documentation to make it more supportive and less cumbersome. Through our collaboration, they were able to gain extensive knowledge. Over time, the client became increasingly self-sufficient thanks to our guidance in various areas.

Later, as the client acquired sufficient knowledge, they took over the responsibility for Release Management. Meanwhile, we focused on writing release tests for as long as the client required our assistance.

Additionally, we aided in preparing release presentations for C-level stakeholders, guided major change releases, and assisted in implementing and testing the Audit Trial feature, going beyond the initial project scope. The Audit Trial functionality within Cornerstone serves to extensively log all system modifications, encompassing alterations in learning objects or user history. Its activation represented a significant change for the client, requiring thorough test coverage.

The collaboration spanned five years, initially involving three active team members from our side, adapting as per project requirements. The project transitioned from our complete management to the client’s active participation. 

Result

For clients operating in a validated environment, ensuring compliance across all their systems is of paramount importance. Our team was fully aware that we were undertaking something of immense importance and critical to the company’s operations. Our intervention rectified the system, ensuring the client’s safety and compliance. 

Continuous consulting provided valuable insights, allowing the client to optimize operations and occasionally resulted in additional assigned tasks or recommendations. The client highly appreciated our professionalism, expertise, and responsiveness.

If you require our assistance in the CSOD Release Management Process, get in touch with us.

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