Clarkston was engaged by a clinical-stage biotech company for an operational excellence in quality project. This client is a leading developer of novel cancer therapeutics with the goal of significantly improving patient outcomes. As a fully integrated oncology drug research and development company, they have established a track record of accomplishments, including advancing the research and development of multiple compounds and clinical programs. A mock audit identified gaps in the current cGxP processes that would prevent the company from passing a PAI inspection. In support of their clinical pipeline and future product commercialization the client was looking for a partner to help them identify gaps and build compliant and sustainable business processes.

Clarkston Consulting was engaged to work with this client to design and support future capabilities, assess their QMS processes and define their Quality Management Systems (QMS). Additionally, Clarkston supported the mock PAI inspection. The client’s partnership with Clarkston resulted in a defined quality organization role and responsibilities process and business strategy overall. They also benefitted from
operational process flows put into place for support of revised and new processes, while still being flexible to be sustainable for future growth. The main resolution was a successful mock PAI inspection with no GMP findings.

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The primary objectives and goals between Clarkston Consulting and the life sciences client for this project included Quality Organizational Design to support current and future capabilities, an overall assessment of the current operational excellence in quality and QMS process, compliance, identification of quality and operational excellence in quality gaps, and support for the mock PAI inspection performed by ex-FDA auditor.

Some of the resolutions for this project included Clarkston defining the quality organizations roles and responsibilities, operational excellence in quality process flows to support revised and new processes, defined various inputs and outputs for processes revised and new, as well as a successful mock PAI inspection with no GMP findings. The key benefits for this project included, but was not limited to, the completion of required training in MasterControl increased from 77% of users completing their training on time to 94% completing their training on time, and the number of days for a document to complete the Document Change Process in MasterControl decreased from an average of over 90 days to less than 30 days.

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To learn more about Clarkston’s life sciences services in quality click here.

Contributions by Melissa Sucha