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PRODUCT SERVICES

Quality Assurance

We recognize the importance of consistent good service and quality and the value of that service being performed in an efficient manner. Rules-Based Medicine is committed to the highest level of quality in our work. Quality and customer satisfaction shall underlie all of our efforts. RBMs is CLIA Accredited and capable of providing GLP support services. This combination allows us to provide our customers with a full range of quality products.

Good Laboratory Practices Assurance

Rules Based Medicine, Inc. (RBM) provides comprehensive Multi-Analyte Profiles (MAPs) as a service to customers and/or collaborators. We are committed to continual quality improvement throughout our services and products and the ability to assist customers in meeting their needs.

RBM is an independent testing laboratory capable of supporting GLP studies. To promote and ensure the quality and validity of our services, RBM works in an environment where the organization, processes, and conditions under which laboratory activities are planned, performed, monitored, and reported are completed to comply with relevant FDA GLP requirements of 21CFR Part 58 when requested. It is the responsibility of the study sponsor to request GLP treatment prior to initiation of testing to ensure all relevant customer requirements are met.

CLIA Accredited

RBM maintains a CLIA Certificate of Accreditation. CLIA ID # 45D1037483

CLIA Accreditation ensures that our laboratory is in compliance with the Clinical Laboratory Improvement Act (CLIA) and is recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

The addition of our CLIA Accreditation complements our GLP compliance as we strive to provide the highest quality products and services achievable. While complying with the FDA GLPs ensures that our facilities, personnel, equipment, SOPs, quality assurance, and records are all in place to produce data that have been conducted in a valid and accurate manner; complying with CLIA ensures that the quality laboratory testing we perform provides the accuracy, reliability, and timeliness of test results for complete quality.

Commercial “Research Use” Compliance Statement - These tests use reagents designated by the manufacturer as “for research use, not for clinical use.” The performance characteristics of these tests were validated by Rules-Based Medicine, Inc. (RBM). The U.S. Food and Drug Administration (FDA) has not approved these tests. The results are not intended to be used as a sole means for clinical diagnosis or patient management decisions.