The Quality Assurance Unit monitors testing to assure that methods, practices, records, and controls conform with applicable regulatory standards, as well as our own internal standards. Our quality assurance program complies with the requirement for contract laboratories as defined by Good Laboratory Practices in 21CFR58, 40CFR160, 40CFR792, as well as Good Manufacturing Practices as defined by 21CFR210, 21CFR211, and 21CFR820. Our quality assurance program complies with the requirements for contract laboratories for the following Nuclear Regulatory Commission regulatory standards: 10 CFR 21 and 10 CFR 50 App B. Because of the variety and broad applicability of test methods, we recommend a thorough discussion of any regulated testing with our quality assurance or technical staff.
Included with all analytical work
The QA Basic service is free and included with all testing and is applicable to non-regulatory routine tests which carry relatively low-risk. Although it is recommended for relatively low-risk testing, it includes many elements to help ensure quality test results. These elements include instrument qualification, system suitability testing, routine calibration with high purity reference materials, independently sourced standards for control charting, blank performance evaluation, continuing calibration verifications, a peer review of test results, and a rigorous training program. General testing, screening tests, research and industrial use are appropriate for this service.
(FDA GLP, cGMP, EPA GLP or Nuclear Regulatory)
This QA Regulatory service is recommended for pervasively regulated industries with conformance to FDA GLP or cGMPs, EPA GLPs or Nuclear Quality systems where the failure outcome represents high risk. QA Regulatory includes fulfillment of regulatory requirements, oversight by a project manager, a 100% inspection of final reports against raw data for conformance to regulatory guidelines, and random in-process performance audits. A GLP or cGMP Compliance statement is included on the laboratory report.
The best practices defined for your needs
The QA Custom service is recommended for clients with unique quality system requirements other than FDA, EPA, or NRC. It is also applicable for the client who desires the highest level of quality assurance available even though no specific regulations or other requirements apply. The service provides all the quality assurance components of the QA Regulatory service. The fee for this service is a 75% surcharge. Additional fees may apply dependent on the scope of the work performed. A thorough discussion of the project and requirements with either our quality assurance or technical staff is required.