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AIQ-Tool®

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Code: #20176

Supplier: AnaTox GmbH & Co KG

Automatic qualification of GC/HPLC/MSD systems by AIQ-Tool®

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  • AnaTox offers by using the AIQ-Tool® software (after training and certification) every customer the option to qualify any system itself or by external providers. The fully validated software allows the customer independent from the manufacturer by using the same procedure for all systems to perform 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 fulfilled. That allows the user to implement all requirements of the corresponding SOP's. It includes for example user management, 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.

    • Automatic detection of all modules and selection of mandatory tests
    • Qualification according recommendations of USP <1058> and customer SOP
    • Complete based on database, fulfills all criteria of highest data integrity
    • Fulfills all requirements according to USP<1058>
    • Integration of traceable references
    • Creation of reports with printing-ID and audit trail printout

 

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