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Automatic qualification of GC/HPLC/MS systems by 

AIQ-Tool


AnaTox offers by using the AIQ-Tool software (after training and certification of the users) the option to qualify any system itself or by external providers. The full validated software allows the customer independent from the manufacturer by using the same procedure for all systems performing the annual qualification or requalification after repair. The user will be guided step by step through the procedure.
All necessary requirements and procedures for a successful audit will be fulflilled. That allows the user to implement all requirements of the corresponding SOP's. It includes for example user mangement, setup und running the qualification depending on the qualification status or documentation. Documentation includes e.g. creation of reports with audit trail and signing according 21 CFR Part 11.

Refrences (selection):

  • USP Chapter <1058>, Analytical Instrument Qualification
  • "General Principles of software Validation: Final Guidance for Industry ans FDA Staff"
  • USP Chapter <621>, General Chapter Chromatography
  • ASTM E685 - 93, Standard Practice for Testing Fixed-Wavelength Photometric Detectors


By using the new AIQ-Tool Software any GC/LC/MS could be qualified automatically.

Features of IQ/OQ/PQ/RQ (selection):
  • Automatic detection of all modules and selection of mandatory tests 
  • Qualification according recommandations of the manufacturers
  • Complete based on database incl. data maintenance and backup
  • Fullfills all requirements according to USP1058
  • Usage of traceable references
  • Creation of reports with printing-ID
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