QualiSys Ltd.is a quality assurance (QA) consultancy firm founded by Douglas McKechnie.
Douglas is a qualified geneticist and molecular biologist, with 36 years’ experience in commercial research and development, including 31 years with AstraZeneca. He moved into quality assurance when working within Cellmark Diagnostics, an AstraZeneca business unit providing DNA fingerprinting services including developing and manufacturing DNA diagnostic tests and kits for inherited diseases and cancer. Douglas developed a quality management system to comply with ISO9000 and holds a Lead Auditor certificate for ISO9000. He specialised in ISO17025 (the international standard for testing and calibration laboratories).
Douglas gained experience in GLP and GCP whilst working in the Quality Assurance group within AstraZeneca Safety Assessment and in the AstraZeneca DNA and Human Tissue Banks. Douglas was the Operations Manager for the AstraZeneca Biobank, responsible for the maintenance of the quality management system, auditing the processes (internal and external) and staff training. He was intrinsic in securing a Human Tissue Act Licence in 2010 and National Research Ethics Service (NRES) Research Tissue Bank approval in 2012, and its renewal in 2017.
In December 2017, he set up QualiSys Ltd, offering independent quality assurance services, including quality management service development, systems auditing and training. Douglas is also a Member of the Research Quality Association (RQA).