Feb 3 2020 IQ/OQ by AIQ-Tool ® software becomes simple and reliable
With the AnaTox AIQ-Tool ® software all chromatographic systems that are approved according to USP/EP/JP can be easily and reliably qualified. The standardized procedure can be used for all systems of all manufacturers. The operation is very simple. The user is guided step by step through all menus and cannot/must not set any parameters. All references are available worldwide. The standards and measuring devices can be freely configured. All data, settings and results end up in a database. Manual reprocessing of the chromatograms is not allowed and ensures high data integrity. The chromatograms can be exported to make the results verifiable. With the database, the qualification history for each instrument can be displayed easily and quickly. If a separate database is created for each instrument, the mixing of qualification data can be avoided and auditing can be simplified. The user administration and documentation naturally meet all necessary requirements such as digital signature and audit trail. AIQ-Tool ® software for instrument qualification with highest data integrity
The AIQ-Tool ® software is a manufacturer independent tool for qualifying instruments supporting highest data integrity fulfilling the ALCOA-guidelines of the FDA.
For laboratories in the (c)GxP environment, the specifications of the USP chapter <1058> became recommended since 2008.The tool helps to characterize the chromatographic instruments by running system checks or full qualification procedures. It offers full access to installation (IQ), operational (OQ) and repair (RQ) qualification procedures.
One of the key features is the “level 4” hardware support of the instruments. With this hardware control a handshake protocol between controller and device is implemented to get active acknowledgement of correct receipt to prevent and detect errors. It is responsible for guaranteed and reproducible execution of data acquisition and therefore for the requirement regarding “original” of highest data integrity. No critical raw data import is necessary anymore. Any action of and parameter sent to the corresponding module with its serial number is recorded in the audit trail. Related Stories
Also in Industry News
How to decide whether or not to start treatment for prostate cancer?
Analysis of the SARS-CoV-2 proteome via visual tools
$65m investment increases British Patient Capital’s exposure to life sciences and health technology