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
erba_xl-1000_sd_comparison_inter_and_intra_batch_.ods
sample_comparison_in_xl-640_and_xl-1000_with_graphs-19-09-2020.ods
eqc_previous_csf_sample_vs_xl-1000_and_xl_640_comparison_.ods
Document->Process->Record