Qualification of proper procedures and practices of Laboratory instrumentation & Equipment (I&E) are vital for the establishment of an operational baseline to ensure demonstrable FDA/EU regulatory compliance standards. In addition, all the software components associated with the instrumentation system, equipments and all interfacing applications must be fit as well for their intended purpose. Our experienced and trained specialists will assist you in qualifying the following laboratory instruments/ instrumentation system, interfacing/ support software applications and equipments, irrespective of the vendor.

• Analyzing Data Scientific Laboratory Instruments: Chromatography, Elemental Analysis, Molecular Spectroscopy, Mass Spectrometry etc 
• Laboratory equipments: Weigh Scales/Balances, dissolution apparatus, moisture determining instruments, ovens/refrigerators/incubators, etc
• Interfacing/Supporting Software Applications: Instrument interfaces, firmware, Data handling/mining/archival/transmission software applications, etc

Xyntek’s I&E Qualification Specialists execute instrument specific protocols that include a comprehensive Design, Installation, Operation, and Performance Qualification (DQ/IQ/OQ/PQ) test protocols. Moreover, our solutions are developed in accordance with our stringent Project Management & Software Development Life Cycle (SDLC) methodology to ensure that our solutions meet your business and process requirements from initial requirements gathering, system design, development, implementation and acceptance, operation and maintenance. Validation is also conducted through all phases in the SLDC to ensure quality solution is built.

For more information on Xyntek's Instrument & Equipment Qualification experience or to find out how Xyntek can help you to realize a solution for your unique Instrument & Equipment Qualification requirement(s), please contact us here.