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Thermo Scientific provides excellent solutions
for "computerized systems" Countries around the world have very strict regulatory requirements for the healthcare and life science industries, such as GLP, GMP, GCP, GQP, etc
.
One of the current hot spots in the pharmaceutical industry is the computerized system, which actually falls under the requirements of
these specifications.
According to the International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Practice Guidelines (GAMP), computerized systems include a wide range of system types
such as clinical trial data management systems, laboratory information management systems, automated production equipment systems, automated laboratory equipment systems, etc.
For computerized systems, the Thermo Fisher Fisher Scientific Chromeleon Chromatography Data System (CDS) provides a simple and comprehensive and systematic way to manage data compliance
in the laboratory.
The system has been rigorously tested during the development stage, and through user management, global policy, archiving policy and audit trail with timestamp, it helps customers achieve the relevant requirements
of the computerized system in GxP in four key links: access control, audit trail, record protection, and electronic signature.
In addition, qualified Thermo Fisher Fisher Fisher Qualifier Analyzer Instrument Qualification Services, Software Routine IQ, OQ and PO Qualification Services, and Comprehensive Customer Training Services, as well as computerized system validation consulting services to reliably control customer chromatography data systems and maintain their validation status throughout their lifecycle
.