====Design Qualification Document==== -A document showing what to do AFTER equipment is produced and BEFORE it is put into actual use -It will include (=defines) - Procedure for installation Qualification - What is required for installation? - Space, electricity, water ,waste arrangement - How to install equipment - Procedure for operational Qualification - What to check before using equipment for field-like use - Are optics working? - Are sample wheels/ reagent wheels working - are probes aligned? - Are waste container alarms working? - It DI water level alarm working? - Procedure for performance Qualification - What to check when equipment is used for field-like use - Calibration - With in batch mean, SD - Between batch mean, SD - EQA report - Equipment comparision - Procedure for maintenance Qualification - Daily, Weekly, monthly,quarterly, yearly schedule {{ :nchsls:c:biochemistry:document:erba_xl-1000_sd_comparison_inter_and_intra_batch_.ods |}} {{ :nchsls:c:biochemistry:document:sample_comparison_in_xl-640_and_xl-1000_with_graphs-19-09-2020.ods |}} {{ :nchsls:c:biochemistry:document:eqc_previous_csf_sample_vs_xl-1000_and_xl_640_comparison_.ods |}} Document->Process->Record ====Installation Qualification Record==== -Installation report from manufacturere ====Operational Qualification Record==== -Operational report from manufacturere ====Performance Qualification Record==== -Records of experiments done ====Maintenance Qualification Record==== -maintenance records {{ :nchsls:c:biochemistry:document:qualification.jpg?linkonly | Definitions from internet}}