|AnaTox offers by using the AIQ-Tool
(after training and certification of the users) the option to qualify
any system itself or by external providers. The full validated software
allows the customer independent from the manufacturer by using the same
procedure for all systems performing 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 fulflilled. That allows the user to implement all requirements of
the corresponding SOP's. It includes for example user mangement, 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.
- USP Chapter <1058>,
Analytical Instrument Qualification
- "General Principles of software
Validation: Final Guidance for Industry ans FDA Staff"
- USP Chapter <621>, General
- ASTM E685 - 93, Standard Practice for
Testing Fixed-Wavelength Photometric Detectors