Novella Clinical’s quality management processes are integral to all aspects of our business. Our independent Quality Assurance (QA) department performs regular quality assessments of our services to ensure compliance with FDA (21 CFR 812), BIMO inspection guidance, and international GCP regulations such as ICH and ISO. We also assess compliance with our SOPs and our commitment to customers.
Our experienced auditors conduct trial master file audits on a rolling basis, ensuring GCP, documentation processes and file structure as well as providing peace of mind for customers. In addition, QA operates a robust vendor qualification process and regularly administers vendor audits through a variety of mechanisms to ensure all Novella’s vendors meet or exceed our stringent standards.
In fact, Novella’s commitment to quality facilitated our North American headquarters to earn ISO 9001:2008 certification in 2004 and recertification in 2010, 2013 and 2016. Today each Novella location operates under our centralized quality management system.
View our Quality Policy here.