AnaTox GmbH & Co. KG

AIQ-Tool®: It has never been easier and safer to carry out GC/HPLC/MSD qualification

GC MSD Overview of testresultsAnaTox (Fuerstenwalde) has released the new AIQ-Tool® software for automatic GC/HPLC/UV instrument qualification for customer. The software is the first manufacturer independent tool for qualifying instruments supporting highest data integrity fulfilling the ALCOA-guidelines of the FDA [1].

For laboratories in the (c)GxP environment, the specifications of the USP chapter <1058> became recommended since 2008, updated August 2017. The tool helps to characterize the instruments by running system checks or full qualification procedures. It offers full access to installation, operational and repair qualification procedures.

One of the key features is the "level 4" hardware support of the instruments [2]. With this hardware control a communication between controller and device is implemented to get active acknowledgement of correct receipt to prevent and detect errors. Moreover, all other controllers are blocked.

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 sending to the corresponding module with it's serial number is recorded in the audit trail.

implemented databaseThe implemented database is used to store raw data, metadata and full qualification reports (regarding "legible" of data integrity). Each report gets its printing ID to track any generation of reports.

The user management defines clear privileges and permissions for each user. AIQ-Tool can be installed at the customer site, there is no interaction with the qualified CDS (chromatography data system). The usage is regulated by digitally signed certificates. Only trained and certified personnel is allowed to run the qualification of an instrument (regarding "attributable" of data integrity) typically performed by a service provider having the traceable media and standards.

Typical data reprocessing is restricted or prohibited (regarding "accurate" of data integrity) to prevent any data manipulation. The parameter setups of running the procedures are fixed, no changing is possible, whereas adapting of limits is allowed. The procedure(s) becomes applicable to all instruments of the same category and supports therefore qualification of instruments from different manufacturers.

A special "reviewer" account allows full digital review of all data, reports and the complete audit trail (regarding "contemporaneous" of data integrity) of the instrument qualification history. The storage of data and the generation of reports is in full compliance with 21 CFR Part 11 regulations of handling electronic records and signatures [2].

[1] "Data Integrity and Compliance with cGMP Guidance for Industry", Food and Drug Administration, Rockville, USA, 2016
[2] Ludwig Huber, "Implementing 21 CFR Part 11 in Analytical Laboratories", BioPharm 13(9), 52-56 (2000)

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AnaTox GmbH & Co. KG
Reinheimer Strasse 18 b
D-15517 Fuerstenwalde

Phone: +49 3361 369895-0
Fax: +49 3361 369895-5
Mail: Contact Contact