QUALITY CONTROL (QC)
QUALITY CONTROL (QC)
Clinical Total Quality Management (cTQM) is a business management strategy and philosophy of perpetual improvement aimed at embedding awareness of quality in clinical research processes. cTQM is implementation of TQM in clinical research and is a revolutionary approach that applies a globally proven TQM to clinical area. In future, cTQM is the way of managing quality in the clinical research, and is far wider in its application than just assuring product or service quality. cTQM is a way of managing people and business processes to ensure complete customer satisfaction at every stage, internally and externally.
cTQM
cTQM plays a vital role in success of the Clinical Research and can make an impact on other business operations of a company, while meeting client needs and expectations. cTQM should be wholly responsible and dedicated to customer satisfaction. cTQM committee is typically headed by Head of Operations and members from all functional departments (like Clinical Operations, Biometrics, Pharmacovigilance, Medical Writing, Medical Affairs, Regulatory Affairs, Project Management, QAU, and IT). cTQM committee is responsible for ensuring customer satisfaction, customer complaints handling, developing CAPA and improve the quality standards.
Improved quality and productivity through increased competitiveness leads to return on investment. This is applied to clinical research, where improved quality leads to increased speed and efficiency, ultimately through registration, and return on investment by accelerated product launch thus benefiting the ultimate benefactor, the patient. cTQM gives everyone in a company the same goal of producing the highest quality product guiding all the business decisions. Make “cTQM a way of life”. This commitment to cTQM can be used as a guide and inspiration for all research organizations.