nchsls:c:biochemistry:document:procedure_for_performance_qualification

Design Qualification Document

  1. A document showing what to do AFTER equipment is produced and BEFORE it is put into actual use
  2. It will include (=defines)
    1. Procedure for installation Qualification
      1. What is required for installation?
        1. Space, electricity, water ,waste arrangement
      2. How to install equipment
    2. Procedure for operational Qualification
      1. What to check before using equipment for field-like use
      2. Are optics working?
      3. Are sample wheels/ reagent wheels working
      4. are probes aligned?
      5. Are waste container alarms working?
      6. It DI water level alarm working?
    3. Procedure for performance Qualification
      1. What to check when equipment is used for field-like use
      2. Calibration
      3. With in batch mean, SD
      4. Between batch mean, SD
      5. EQA report
      6. Equipment comparision
    4. Procedure for maintenance Qualification
      1. 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

Installation Qualification Record

  1. Installation report from manufacturere

Operational Qualification Record

  1. Operational report from manufacturere

Performance Qualification Record

  1. Records of experiments done

Maintenance Qualification Record

  1. maintenance records

Definitions from internet

nchsls/c/biochemistry/document/procedure_for_performance_qualification.txt · Last modified: 2022/08/13 07:34 (external edit)