HPLC -- Chromatography
We are specialiced in Agilent/HP Components. Most of them are on stock. ( 1100/1200/1260/1290). Our technicians will check and service each Device and bring it to Manufacturer Specifications. The minimum Warranty is 3 months and can optionally get an upgrade to the Maximum of one year.
Qualification:
If you are working in a regulated area, we can offer also the Qualification for your Instruments. We use a manipulation-free procedure and have the highest data integrity on the market.
For laboratories in the GxP environment, the specifications of the USP chapter <1058> became mandatory since 1 August 2008. For all equipment of category C, (HPLC is included) the documentation according the so called 4Q-model will be expected.
The 4Q-Modell describes and regulates the gradual approach of all qualification processes. The process starts with the design qualification where the user compares the requirements of the analytical method with the specification of the instrument manufacturer (DQ). If the customer has ordered the optimal equipment it must be installed with a short operation check and the shipment with all options must be compared with the order (IQ). At the next step the equipment must be qualified according to the operational and performance specification OQ/PQ.
During the OQ/PQ, the operability of the system according to the requirements of the DQ is checked against specific tests with traceable measurements.
With our new qualification software AIQ-Tool we meet all requirements of the USP 1058 on the basis of manufacturer specification and the requirements of typical monographs as well as USP chapter <621>. The software provides traceable data and results on the basis of a manipulation-free procedure with highest data integrity (integrated data base).
Qualification:
If you are working in a regulated area, we can offer also the Qualification for your Instruments. We use a manipulation-free procedure and have the highest data integrity on the market.
For laboratories in the GxP environment, the specifications of the USP chapter <1058> became mandatory since 1 August 2008. For all equipment of category C, (HPLC is included) the documentation according the so called 4Q-model will be expected.
The 4Q-Modell describes and regulates the gradual approach of all qualification processes. The process starts with the design qualification where the user compares the requirements of the analytical method with the specification of the instrument manufacturer (DQ). If the customer has ordered the optimal equipment it must be installed with a short operation check and the shipment with all options must be compared with the order (IQ). At the next step the equipment must be qualified according to the operational and performance specification OQ/PQ.
During the OQ/PQ, the operability of the system according to the requirements of the DQ is checked against specific tests with traceable measurements.
With our new qualification software AIQ-Tool we meet all requirements of the USP 1058 on the basis of manufacturer specification and the requirements of typical monographs as well as USP chapter <621>. The software provides traceable data and results on the basis of a manipulation-free procedure with highest data integrity (integrated data base).
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