LC/GC/MS instrument qualification is simple and reliable.
With the AIQ-Tool® software, all chromatographic systems that are approved according to USP/EP/JP can be easily and reliably qualified. The standardized procedure(s) can be used for all systems of all manufacturers.
The benefit: only one tool for all chromatographic systems
Easy operation by guided handling
The operation is very simple. The user is guided step by step through all tasks and must not set any parameters. The mandatory tests will be automatically generated and cannot be deselected.
The benefit: comparable and reproducible results even if used in-house by laboratory personnel
The hardware is auto-detected and any change will be detected. The configured
modules/devices are registered in the database and the qualification state of each module is tracked. The standards and measuring devices can be freely configured. All data, settings and results end up in a database.
The benefit: up-to-date overview of the qualification state
Hardware control without CDS
The qualification runs independently from the customer CDS. The level-4 hardware support guarantees full access to the chromatographic system. All status information, the complete parametrization, as well as error messages are recorded in the audit trail protocol.
The benefit: no influence on the validated customer CDS with full traceable recording of any qualification step.
Manual reprocessing of the chromatograms is not allowed and ensures highest data
integrity. The raw data can be exported to make the results verifiable.
The benefit: high automation and reproducible results
.With the database, the qualification history for each instrument can be displayed easily and quickly. The user administration and documentation naturally meet all necessary requirements such as digital signature and audit trail.
The benefit: fulfils all criteria of USP/EP regulations, simplifies audits.