Product category:
Instrument control software
News Release from: Dionex | Subject: Chromeleon
Edited by the Laboratorytalk Editorial
Team on 06 June 2002
21 CFR 11 compliance technical note
Comprehensive guide to the use of chromatography management software to meet the requirements of the US FDA's the Electronic Signature and Records Act
A new 16-page technical note from Dionex explains how the Chromeleon chromatography management software helps ensure compliance with 21 CFR Part 11, the Electronic Signature and Records Act The new document, richly illustrated with 28 colour screen images, cites each relevant section of the law and describes in detail how the software facilitates compliance
This article was originally published on Laboratorytalk on 16 May 2008 at 8.00am (UK)
Related stories
Chromeleon features include Vista compatibility
Service Pack 3 for Release 6.8 of Chromeleon chromatography management system from Dionex supports Microsoft Windows Vista operating system
Well plate capability added to the AS Autosampler
The AS with the new well plate capabilities is the perfect fit for the ICS series and is fully supported by Chromeleon chromatography management software
Chromeleon provides a comprehensive suite of validation, security, electronic signature, and audit trail capabilities.
Validation is fast and easy with the software's IQ, OQ, and PQ automation tools, which also ensure adherence to SOPs.
Security can be enforced at three layers: operating system, database, and application.
Further reading
Method scouting made automated
Dionex introduces a new intelligent LC (LCi) solution for automated method scouting, based on its UltiMate 3000 Series HPLC systems and Chromeleon software
Chromatography software boosts automation support
Latest release of chromatography management package supports automation for a wider range of popular instruments and allows legacy data to be imported
The application layer has over 90 chromatography-specific privileges that can be separately assigned to an unlimited number of privilege groups.
Access to instruments and data can be controlled through any number of access groups.
Folders can be locked at any time to prevent modification of contents.
The software can enforce password length and ageing policies, disable accounts with too many failed login attempts, and automatically lock inactive clients.
Electronic signature support is seamlessly integrated, enhancing workflow.
Subject to administrative controls, various individuals and/or groups can be designated as signatories (submitter, reviewer, and/or approver).
Signatories can conveniently locate, view and sign results, and all details of all signature operations are captured and reported.
Signed results are automatically locked and hash-coded, and their authenticity can be instantly confirmed.
Audit trails include detailed security logs, instrument event logs, and histories of modifications made to all types of data objects.
Audit trails can be viewed in real time, reviewed post-run, and included in reports.
Audit trails are faithfully preserved when data are archived and restored.
Chromeleon fully controls over 150 different HPLC and GC instruments from many different suppliers, including Agilent 1100 LCs and 6890 GCs, and ThermoFinnigan SpectraSystem LCs and AQA mass spectrometers.
Chromeleon's database quickly locates samples matching any combination of sequence, sample, or result criteria, and its Excel-compatible spreadsheet provides easy, flexible, and powerful ways to report results for individual or multiple samples.
The software's client/server architecture scales up smoothly from individual workstations to multi-user environments.
To order a copy of the technical note, visit the Dionex webite (details above). Request a free brochure from Dionex ...
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