ResLabQ&C Ltd
Clinical Research Laboratory
Quality and Compliance
Quality Management Systems
The implementation of an appropriate Quality Management System (QMS) is the best way to achieve and maintain standardisation, and to minimise delays. A robust QMS is an essential component of your quality assurance function that ultimately provides confidence that the quality standards expected will be achieved.
In laboratories that analyse samples collected from clinical trial participants there is an absolute requirement for the results produced to be as accurate as possible and reported on time. The MHRA will expect that an effective QMS has been implemented to ensure that all laboratory operations are conducted in manner compliant with laboratory Good Clinical Practice (GCP) standards (also known as Good Clinical Laboratory Practice; GCLP).
Within HTA-licensed facilities and biobanks storing cells and tissues for future research (research sector) or procuring, processing, testing, storing, and distributing tissue and cells for human application (application sector), an appropriate QMS is a requirement by the HTA to fulfill their quality standards.
How can we help?
From project or facility set up, ResLabQ&C can provide guidance and expertise in the development and implementation of quality policies, procedures, and tools to assist and ensure compliance with the regulations from the start. We can also assist with the assessment and improvement of existing systems to enhance performance in addition to compliance.
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The QMS service ranges from the evaluation and review of existing documents, to the provision of complete ready-to-review documents that will build you a fit-for-purpose quality system from scratch.
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