Comprehend Systems

Finally: Clinical Trial Speed and Quality


Clinical operations quality control is a major issue in today’s Life Sciences market. The current method of getting drugs and medical devices through the clinical trial process is broken because of a lack of process transparency and data holes. According to CenterWatch, 86 percent of clinical trials experience delays, due to a data quality gap. Additionally, under 10 percent of clinical trials are completed on time. The root cause: poor data quality that slows down results and go-to-market. Old processes will no longer work and Life Sciences companies need to embrace the power of new technologies to modernize clinical trials.
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In The Headlines

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Trends in Enforcement Actions – What 2014 Can Tell Us about the Road Ahead


Changes in international legislation and trends in enforcement have continued to be a moving target for 2014 and 2015. In the area of FCPA enforcement, several trends provide guidance on what companies need to be conscientious about in the coming year. In the area of international regulations, there continues to be an upswing in the number of countries that have added new regulations or tightened requirements around existing legislation to send a message regarding their efforts to reduce corruption.
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Topic of Discussion

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Health Check: How CAPA Programs Reveal the Real Ailments Affecting Quality


Quality control is a vital component of any pharmaceutical manufacturing facilities operations. It is the system of checks and balances that ensures a safe, high-quality product.
 
The Quality Management System (QMS) provides the written policies and procedures ensuring products are safely and consistently manufactured to meet approved quality standards.  A robust QMS of an aseptic processing facility is predicated on contamination risk management. Well documented risk assessments should be site specific and take into account not just the basic elements of good aseptic practices, but also a full evaluation of all potential contamination ingress (component flow, personnel flow, process flow).  The assessment should then drive all future decisions that build a quality by design system. Continue reading "Health Check: How CAPA Programs Reveal the Real Ailments Affecting Quality"