GCP Compliance: Eliminating Silos Between Clinical Quality And Clinical Operations

By Patricia Santos-Serrao, Director of Product Strategy, MasterControl

Many companies mistakenly believe that quality and clinical are completely separate departments that should maintain their data and processes in discrete silos. What these organizations are overlooking are the benefits that can be achieved by applying the same tools and methods in the clinical space that they are already using for quality management.

A QMS is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. In a nutshell, it is the organizational structure, documents, policies, procedures, processes and resources needed to implement quality management.

But a standard QMS leaves gaps that only can be filled by a holistic, integrated system. Having two separate systems for clinical QA and clinical operations creates silos and inoperability that impedes the ability to embed cross-functional best practices across clinical research. The solution is a clinical quality management system (CQMS) that truly brings clinical operations and clinical quality together.

Read how a holistic Clinical Quality Management System (CQMS) can bring together all of the quality management and risk management efforts managed by both clinical quality and clinical operations under a single clinical research organization.