Qualification

JASCO Validation and GLP Program JASCO (UK) Limited offers a comprehensive validation and qualification support package. By working closely with users of JASCO instrumentation, the service group can and will meet the challenge of current and future regulatory requirements. Qualification workbooks documenting ready to use SOP’s (standard operating procedures) for IQ, OQ, MQ and PQ are now available. Details of standards, their trace ability and certification are included in the comprehensive package. Validation A reference to the total life cycle of a product from definition, through to operation and maintenance. Qualification The testing and documentation part of the validation process that verifies module and system performance prior to on-line use. Installation Qualification (IQ) The review of all information relating to the correct installation, operation and maintenance of an HPLC module or system. "We ensure that the installed module or system operates safely and efficiently". Operational Qualification (OQ) The documented verification of module performance covering accuracy, linearity and precision specifications. "Our procedures ensure that the product built in an IS0 9001 environment, performs to the highest operating standards in your laboratory". Maintenance Qualification (MQ) Documentation of module and/or system maintenance, calibration, performance testing.  "The goal of our factory trained engineers is to maintain instrument performance at the documented operating specifications".

Performance Qualification (PQ) The verification of system performance using test mixtures and validated methodology to ensure reproducibility of results. "The tests carried out on a fully installed and serviced system ensure that the JASCO HPLC performs to the published specification". JASCO Validation Support Protocols Ready to use "SOPS" for documenting Installation Qualification (IQ) Operational Qualification (OQ) Maintenance Qualification (MQ) Performance Qualification (PQ) Qualification Test Chemistry Kits JASCO Qualification Test Chemistry Kits PQ test column for UV-based systems Gradient proportioning accuracy Wavelength accuracy Detector linearity Injector accuracy PQ test mixture JASCO Validation Package Documented workbook Traceable test materials Certified calibration of test equipment Certified service representative