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Quality Assurance

At IIVS, good quality assurance practices are firmly rooted throughout the entire organization. Providing the highest quality laboratory work and consulting services to our partners is the job of every employee, not just those working in the Quality Assurance Unit (QAU). Hosting numerous sponsor and regulatory audits for compliance with the Good Laboratory Practices (GLP) of the FDA, EPA, OECD, MHLW and others, has strengthened our culture of quality and helped us to stay at the forefront of the application of GLP principles to in vitro studies.

Standard services provided by our QAU include: performing protocol, data and report audits; reviewing Standard Operating Procedures (SOP); providing training in GLPs; hosting Sponsor and regulatory inspections; and performing computer system and vendor audits. In addition, the QAU performs at least one laboratory phase audit of every GLP study. The QAU staff has also performed audits of international validation studies and is available to perform quality control/quality assurance audits of regulatory submissions to agencies such as ICCVAM and ECVAM.

The QAU also provides external training on the functional application of regulations for in vitro assays. These training sessions are included in our annual “Practical Methods for In Vitro Toxicology” course. We tailor QA workshops for individual companies and quality assurance professionals. Through publications, posters, and presentations, IIVS staff seek to educate the global regulatory and toxicological community on the use of in vitro assays in a regulated environment.

We continue our leadership in this field with a pioneering vendor audit program which is the first of its kind to include manufacturers of in vitro test systems. Reliable test systems are necessary for reproducible data and hasten the acceptance of alternative methods. We are eager to partner with our sponsors to provide vendor and subcontractor facility audits to ensure that all components of in vitro assays are of the best possible quality.

We welcome your visit to our facility and look forward to discussing our Quality Assurance program with you.