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Top Tips for Clinical Quality

Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) are fundamentally similar, in that the goal of each is to refine processes to ensure quality and facilitate conformance to regulatory guidelines. Both fall under the umbrella of good ‘execution’ practices (GxPs), which is intended to ensure consistency, data integrity, accountability, traceability and overall quality.

Understanding Operational Efficiencies

To see how GMP strategies can benefit the clinical world, it is necessary to thoroughly comprehend what a quality management system (QMS) is and what it is intended to do. A QMS is the collective set of policies, procedures, methods, resources, documentation and infrastructure required for the effective implementation of quality control and assurance in an organisation. The focus of these interrelated processes and activities is the achievement of quality objectives and policy that allow companies to execute measurable and repeatable procedures that meet regulatory requirements.

While some firms still rely on paper-based QMS operations, the use of a variety of hybrid paper-electronic systems or fully electronic QMSs is now more common. Historically, the QMS software solutions on the market have included modules for managing documents, training, quality events and reports/analytics. Automated QMS products currently on the market feature solutions specifically designed to manage other quality-related areas, such as audits and suppliers, under a single platform. While many enterprise QMS solutions are installed on premise, technological advances have spurred a trend of life sciences companies adopting cloud-based QMS solutions.

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Patricia Santos-Serrao, RAC, is a life sciences professional with over two decades of experience in quality, regulatory and clinical business processes for the pharmaceutical and biotech industries. She worked for several Tier 1 companies, including Schering-Plough and Boehringer Ingelheim, prior to transitioning to various technology solutions and services providers for life sciences. Currently, Patricia is Director of Pharmaceutical and Biologics Solutions at MasterControl, developing solutions designed for the pharma industry with a focus on clinical operations, quality and regulatory affairs.
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Patricia Santos-Serrao
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