LC-2010HT

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Easy Validation realized!ValidationAnyone can promptly perform high-level validation at any time!Supports GLP and GMP to an even greater degree.High levels of validation in every field are required for analytical instruments that have to complywith regulations such as GLP, GMP, and ISO. The LC-2010HT is equipped with an auto-validationfunction to enable high-level validation of hardware.Used with LCsolution and CLASS-Agent manager, results of validation are saved as electronicrecords.Auto validationPreviously, knowledge and experiencewere prerequisites for executing validationtests, but now anyone can performvalidations using a uniform procedure.The LC-2010HT auto-validation functionautomatically finishes in approximately 1.5hours in isocratic mode and approximately3 hours in gradient mode.Validation executionValidation startValidation finishAuto validation tests important parameters such as solvent deliverystability, wavelength accuracy, absorbance level, and column temperature.Performance checkThe performance-check function can be used if the validationof each unit is to be performed independently. This is a usefulfunction when validations such as accuracy of the pump flowrate and injection volume accuracy need to be performedindividually. This performance check can be executed even ifthe instruction manual is not available, since the validationprocedure instructions are displayed on screen.Performance check screen8
System checkDaily checks can be performed automaticallywith the system check function. Device statuscan be easily checked as auto validation andperformance check functions record the latestvalidation results together with deviceself-diagnosis results and the remaining servicelife status of consumables.System check screenSystem check reportSystem suitability testLCsolution is equipped with a QA/QC function as standard so thatsystem suitability tests can be easily performed on a daily basis. Also,it is possible to automate the operations that occur in a routineanalysis, such as re-injections and analysis cancellations that dependon test results if the auto-validation function for results is used.QA/QC reportIQ: installation QualificationOQ: Operational QualificationIQOQOQFDA compliance supportWhen devices are installed or reinstalled due to amove, checks must be carried out to ensure that theinstallation environment and device meet thespecifications and the device performance meets theestablished criteria in order for the instrument tocomply with FDA inspections. In the case ofinstallation qualification (IQ) checks, analysis devicespecifications, software, attached documents, andsuitability qualification at the time of deviceinstallation (including installation environment checkas well as customer training certificate) are required.With the LC-2010HT, installation qualification andoperational qualification (OQ) documents areattached as standard. Shimadzu qualified servicepersonnel perform installation qualification andoperational qualification (service cost is not included).9
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LC-2010HT

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