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. 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.
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).
