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Quality Assurance |
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| Cambridge Biomedical has a Quality Assurance Unit (QAU) that assures the highest quality standards for all laboratory services and promotes continuous improvement throughout the company. The QAU staff has an extensive scientific background and laboratory experience. The QAU staff has extensive experience and knowledge in working with regulatory agencies. |
Key QAU Activities
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- The QAU staff works hand in hand with our clients to explain all processes and guidelines that are required for every project.
- Maintain all standard operating procedures, with regular and timely documentation and review.
- Assists in maintenance and accreditation and licensure within the appropriate states, the College of American Pathologists, CLIA, and other agencies involved in laboratory regulation.
- Enhance expertise of technical personnel by developing and maintaining a continuing education program for all employees including proficiency and competency testing.
- Provide oversight for a comprehensive internal / vendor audit and corrective/preventive action program (CAPA) program
- Provide oversight for comprehensive system validation.
- Host regulatory agency audits.
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Laboratory Quality
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Cambridge Biomedical holds its laboratory to the highest quality levels for both diagnostics and pharmaceuticals. We are CLIA Certified, CAP Accredited, provide services that support best laboratory practices and GLP compliance and registered with the FDA.
Click here to view our licenses
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Clinical Laboratory Improvement Amendments of 1988 (CLIA)
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The Clinical Laboratory Improvement Amendments of 1988, or CLIA, resulted from a Congressional examination of lab practices, including investigation of testing performed in Physicians Office Laboratories (POLs). CLIA sets standards designed to improve quality in all laboratory testing and includes specifications for quality control, quality assurance, patient test management, personnel and proficiency testing.
CLIA regulations set minimum standards for laboratory practice and quality. When a laboratory satisfies CLIA regulatory requirements, you can have greater confidence in the quality and reliability of laboratory results. |
College of American Pathologists (CAP)
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When an institution chooses to be CAP-accredited, you can be assured that its laboratory will not only meet federal regulations, but will exceed them. Participation in the CAP Laboratory Accreditation Program demonstrates to patients, clinicians, and payors a continuum of high-quality testing in the clinical laboratory. No other accrediting agency inspects infertility labs as a sub-specialty.
The laboratory is the most complex ancillary service. CAP inspections are performed in this complex environment by experienced, knowledgeable professionals who are in tune with emerging technologies, new procedures, and patient issues.
Dedicated laboratory physicians are the foundation and leadership of the College of American Pathologists. Their adherence to the most stringent requirements in laboratory accreditation ensures accountability for quality laboratory results and ultimately improves patient outcomes. Accurate and reliable laboratory results can significantly contribute to improved patient outcomes. |
GLP (US FDA Title 21CFR 58)
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| Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. Medicines and Healthcare products Regulatory Agency-UK |
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CRO SERVICES
"Very good technically. People clearly knew what they were doing - knew how to handle assays, data management."
Pharmaceutical Clinical Trial Manager |
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