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Thermo Fisher Scientific

065448 Part E - Rev 7.30a - Chromeleon Operational Qualification and Performance Qualification Software Templates for ICS-5000, ICS-5000+, ICS-6000 Analytical Instruments - User's Guide

Step-by-step guidance covers preparing Chromeleon and ICS-3000 hardware and generating qualification sequences with the Instrument Qualification Wizard, then run OQ/PQ tests in the prescribed order. It details module compatibility, required kits, sample layouts, and pass/fail limits. It also shows how to use the Instrument Qualification Wizard to auto-build sequences and run them in order, with troubleshooting and example reports for GLP/cGMP records.

Description: 

It is recommended that the most current revision of the OQ-PQ software templates is used in order for a qualification to be considered valid. It is the responsibility of the qualification engineer to determine the most up to date revision of the templates available and ensure that the revision is used before proceeding with this qualification or if the customers SOP require an earlier OQ-PQ version to be used.

Environment:

  • Chromeleon 7.1

Module, Minimum Chromeleon Software Version

  • AS-AP 7.1 SR1 DU0C
  • AS 7.1 SR1
  • AS-DV 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 SP 7.1 SR1
  • ICS-6000 DP 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 EG 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 DC 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 CD 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 ED 7.1 SR1
  • FLUKE189-289 7.1 SR1
  • ICS Series VWD 7.1 SR1
  • ICS Series PDA 7.1 SR1
  • ICS-5000 7.1 SR1
  • ICS-5000+ 7.1 SR1
  • ICS-6000 TC 7.1 SR1