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The life sciences industry consists of organizations dedicated to creating products to improve the lives of organisms. This includes companies in the fields of pharmaceuticals, biotechnology, medical devices, biomedical technologies, nutraceuticals, cosmeceuticals, and food processing. Quality and safety regulations are common to all and are especially stringent when involving human subjects. Test and measurement instrument calibration supports product and process safety, and quality for effective and accurate results. Transcat offers equipment and tool calibration services to comply with regulations such as the FDA's Good Manufacturing Practices (GMP, GCP, GLP, and cGMP). Contact us for the expert calibration services you need for your operations within the life sciences industry.
Calibration Requirements for Organizations within the Life Sciences
Pharmaceutical Manufacturing
To produce high-quality and uniform products, pharmaceutical manufacturers must be diligent about sanitation and accuracy, from receiving raw materials to production, packaging, and storage.
Hospitals
Medical equipment and instruments used across hospital settings must comply with unique validation and calibration requirements for accuracy, reliability, and safety.
Test Labs
Calibrated test instruments and equipment drive the accuracy and reliability of test results for all kinds of life sciences test labs.
Clinical Labs
Testing biological specimens for healthcare facilities requires calibrated instruments to aid physicians in diagnosing, treating, and managing patients.
Contract Research Organizations (CRO)
The repeatability of research results requires careful attention to procedures and analysis methods using calibrated test and measurement instruments to support the pharmaceutical, biotechnology, and medical device industries.
Research Universities
To drive innovation in the life sciences, research universities are highly regulated to ensure the safety of personnel and the environment. Calibrated test and measurement instruments support the safety of their use and the integrity of experimental results.
Common Life Science Processes
Sample Preparation and Testing
Regular instrument calibration is essential to ensure the accuracy and reliability of clinical and non-clinical test results and to comply with regulatory standards. Transcat instrument validation and calibration services cover common lab instruments, including centrifuges, microscopes, automated analyzers such as chemistry or immunoassay analyzers, automated sample processors, chromatography systems (HPLC, GC), spectrophotometers, dissolution testers, pipettes, and pH meters.
Environmental Controls
Environmental conditions must be controlled from clean rooms to operating rooms. Equipment and environmental monitoring instruments such as temperature and humidity loggers, particle counters, and air samplers, require calibration for accuracy and compliance.
Quality Assurance and Compliance
Organizations in the life sciences must maintain quality assurance procedures to ensure compliance with regulatory requirements. This includes conducting proficiency testing, participating in external quality assessment programs, performing regular audits, and maintaining equipment and test and measurement instruments. NEXA | EAM, a Transcat Company, provides quality management services to ease the compliance burden for organizations in the life sciences.
Featured Transcat Solutions for the Life Science Industry
Instrument Metrology and Repair Services
Transcat Biomedical is a leading, national provider of quality instrument metrology and repair services. Our services are available on-site or from one of our ISO 17025-accredited biomedical labs.
Pipette Calibration and Supplies
Transcat Pipettes offers 3–5-day turnaround for pipette calibration services and as fast as 24-hour turnaround within defined service areas. We are also a multi-brand distributor of high-quality pipettes, pipette tips, and benchtop equipment.
Enterprise Asset Management (EAM)
NEXA | EAM, a Transcat Company, provides technical, consulting, and staffing solutions to improve asset management programs for life science industries in North America, Europe, and Asia Pacific. Asset management services include calibration, maintenance and spares, reliability, CMMS, quality, compliance, and CQV services.
Pharmaceutical, Medical Device, and Laboratory Validation Services
These specialized validation services provide documented evidence that your systems, facilities, and processes perform their intended functions according to specifications set by the FDA or custom protocols. Service options through NEXA | EAM, a Transcat Company, include qualification of new installations, validation, revalidation, and instrument calibration.
Ask about our full range of test and measurement devices and services for the life sciences industry. Call one of our calibration professionals at 800-828-1470 or contact us.