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CQMS Consulting Project for a Clinical-Stage Biopharmaceutical Company


A clinical-stage global biopharmaceutical company with major hubs in the US and Japan requested that Avoca perform an in-depth review and assessment of its Clinical Quality Management System (CQMS) with a special focus on Vendor Oversight, Risk Management, Technology Business Requirements, and Quality Tolerance Limits (QTLs).

The project objectives were to identify and document current gaps relative to recently refined global regulations and industry-leading practices, and to provide guidance in the design and development of vendor oversight practices, including centralized approaches for oversight and risk management to align and enhance their regional units to integrated processes and tools that enhance their comprehensive global CQMS.

A focused section of this project included a Technology Business Requirements Analysis which was integrated into an ongoing global project at the company.

The company also requested that Avoca review the requirements and implications of ICH E6 (R2) and their bearing on the company’s current processes and then author modifications required to achieve compliance.

Because the company was a member of the Avoca Quality Consortium (AQC), Avoca’s project team leveraged AQC leading practices, where applicable.

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