In this case study, we describe our partnership with a biopharmaceutical client to help them tackle their global Quality Management System (QMS) process redesign. The client is a multi-national, research-based biopharmaceutical company. Founded over 30 years ago, this client’s medicines and pipeline are designed to help patients with a number of life impacting diseases.

This biopharmaceutical company faced significant challenges with its quality management system and automation platform used to support and optimize ongoing quality change controls. The client’s rapid organizational growth and global expansion led to an extremely complex change management process, and system instability for performance and reliability. These were disruptive to the business and caused the stakeholders to have reduced confidence in their QMS.

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Clarkston Consulting collaborated with the client to redesign and streamline the client’s global change management system to be a compliant, collaborative, and scalable process that increases stakeholder’s usability and confidence, improves compliance, and proactively eliminates regulatory exposure. The team initially identified, collected, and collated User Requirement Specifications (URS) from stakeholders in multiple functions that are impacted by multiple GxP changes. Other primary objectives for the team included summarizing and presenting industry best practices and streamlining and developing future state process maps and vendor demo scenarios.

This project resulted in a single foundational process for all changes with a workflow creation and requirements driven by selection criteria, execution of SME-led global QMS process change management workshops, establishment of seamless connectivity with other GxP systems within the organization, and so much more. Some of the key benefits to the organization resulting from this partnership project with Clarkston included cross-functional alignment on the change’s content, reduction in paper-based documentation, cost savings due to increased efficiencies and enhanced quality compliance, and increased user confidence and usability of the global QMS process.

Download the full Global QMS Process Redesign Case Study here.

Contributions from Segun Olorunyolemi