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Food Processing News
News Release from: Metrohm UK | Subject: Metrohm TiNET 2.5
Edited by the Processingtalk Editorial
Team on 22 July 2003
FDA compliant Titration and Karl Fischer
software
Metrohm TiNET 2.5 is the only fully working FDA compliant Titration and Karl Fischer software, externally audited to the requirements of CFR21 part 11 and certificated by Chemgineering
Metrohm TiNET 2.5 is the only fully working FDA compliant Titration and Karl Fischer software This software has been externally audited to the requirements of CFR21 part 11 and certificated by Chemgineering
This article was originally published on Processingtalk on 2 Jul 2008 at 8.00am (UK)
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Current users of this software include companies such as Pfizer and Astra Zeneca.
What is FDA CFR 21 Part 11?.
FDA is the American Food and Drug Administration.
Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice).
CFR means Code of Federal Regulations.
Part 11 covers all FDA issues pertaining to electronic records and electronic signatures.
21 CFR Part 11 is here to stay, manufacturers will not be able to supply to US markets or users without complying.
In the very near future it will no longer be possible to just print out a result from a Titrator or Karl Fischer Instrument, without adhering to the regulations in 21 CFR Part 11.
The Metrohm TiNET 2.5 fulfills all the demands of this ruling and more.
It stores identities consisting of unique user names or profiles and unique passwords.
Users must enter a valid user name and password.
There is automatic log-off of the unit after a user-defined period.
The user password has to meet or exceed a minimum length.
This password expires at regular definable intervals.
The software records audit trails for all parts of the software including user accounts.
Audit trails, result files, methods, configurations and user accounts are stored encoded and protected against manipulation and editing.
All the equipment methods are encrypted and all versions are stored and traceable.
Further the Metrohm unit is pre-prepared for long term archiving programmes such as NuGenesis, e-Recordmanger and Cyberlab. Request a free brochure from Metrohm UK ...
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