CSOD Release Management Process for a pharma giant
By eConsulting
Client
Project Description
Subject:The client is a multinational pharma company specialized in the research, development, and manufacturing of drugs and vaccines. The client used the Cornerstone system in their organization, particularly in departments operating in regulated markets. Compliance with regulations requires maintaining the system in a constant validated state. Therefore, the client decided to engage the eConsulting team to coordinate the release management process of the CSOD system, ensuring controlled and secure processes for any changes or modifications in the system. Scope of work:We started by gathering information about the client’s validation methods and system usage. This enabled us to execute the release management process covering the configuration and business use cases. The project involved individuals from our CSOD department and Validation team members responsible for documentation. 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. Over the years, we have been educating the client on best practices for Release Management and Patch Management. As the client acquired sufficient knowledge, they took over the responsibility for Release Management. 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 intervention rectified the system, ensuring the client’s safety and compliance. The client highly appreciated our professionalism, expertise, and responsiveness.
Subject:The client is a multinational pharma company specialized in the research, development, and manufacturing of drugs and vaccines. The client used the Cornerstone system in their organization, particularly in departments operating in regulated markets. Compliance with regulations requires maintaining the system in a constant validated state. Therefore, the client decided to engage the eConsulting team to coordinate the release management process of the CSOD system, ensuring controlled and secure processes for any changes or modifications in the system. Scope of work:We started by gathering information about the client’s validation methods and system usage. This enabled us to execute the release management process covering the configuration and business use cases. The project involved individuals from our CSOD department and Validation team members responsible for documentation. 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. Over the years, we have been educating the client on best practices for Release Management and Patch Management. As the client acquired sufficient knowledge, they took over the responsibility for Release Management. 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 intervention rectified the system, ensuring the client’s safety and compliance. The client highly appreciated our professionalism, expertise, and responsiveness.
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