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.
The 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 contact with the qualified CDS (chromatography data system). The usage is limited and 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 standardized procedure(s) is/are 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.