Quality Assurance at KCAS

Quality Assurance at KCAS

In pursuit of KCAS’ Mission to provide reliable and defendable data, quality is one of our core values. It is the responsibility of every employee to provide an always improving, high-level performance in all we do. Our independent Quality Assurance Unit (QAU) assures management that Operations is performing in conformance with all applicable regulations.

KCAS’ ability to provide review of procedures, training, facilities, methods, equipment, systems, data and reports in a timely manner is what sets our QAU apart. KCAS QA coordinates review with Operations to ensure the timelines of our sponsors are met, or exceeded, and quality is not sacrificed. Our system allows data and reports to be submitted for review in “real time.” This means after analyzing a set of samples or a group of validation batches, the data may be submitted for review and immediately returned to Operations with a report of the audit. This allows Operations to have rapid feedback in the event revisions or corrections are needed. The swift turnaround time is vital to keep strict timelines and to ensure the study is moving forward in the right direction.

KCAS Quality Assurance stays current with regulatory expectations by participating in professional organizations such as Society of Quality Assurance, reading the latest white papers, and attending meetings that discuss hot topics throughout our industry, such as Workshop on Recent Issues in Bioanalysis. In 2016, the FDA provided a proposed rule making changes to the current GLPs and welcomed comments from the industry. We are eager to learn what the FDA will do with all of Industry’s comments and what the revised product will be. In preparation of the new rule, KCAS QA will implement a Quality Management System in 2018 allowing us to mitigate the shock wave when the new rule is published. With our preparation we anticipate insignificant impact on our clients.

As prospective clients or current clients come to KCAS to qualify our laboratory or review their study, QA makes sure they are provided all of the information requested. Including but not limited to our FDA Inspection history, our SOPs and our training records. When a client has a recommendation to improve our lab, Quality Assurance listens and helps to implement suggested actions.

With the assistance of Quality Assurance, our customers and management can rest assured Quality will not be sacrificed and we have provided the highest quality data to our clients.

 


 

 

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