A Chromatography Data System (CDS) must provide an easy way to adhere to GxP regulations, policies and procedures without sacrificing the user experience. Thermo Scientific Chromeleon 7.3.2 Chromatography Data System provides regulated laboratories with a complete solution to maintain data integrity and meet 21 CFR Part 11 electronic signature requirements with confidence throughout the data lifecycle with features that make building and maintaining the system intuitive to users, less stressful for reviewers, and intrinsic for software owners.
Learn how Chromeleon CDS gives you the tools to manage and maintain records with granular access control, automated file management, an expandable architecture with built-in qualification tools, and a refined data integrity framework. All to help enhance productivity with the highest quality of your GxP results.
What are users saying?
"Chromeleon CDS allows us to audit trail everything that we need to, making it easier when we are audited. The user management system and centralized resourcing means that data access and backup is easily managed, ensuring data integrity."
- QC Specialist, Broughton Laboratories
Establishing and maintaining a validated state can be a resource heavy task. Chromeleon CDS can help those efforts through a combination of built-in tools and additional services to get you started or take your system to the next level.
Security is more than user password complexity. Ensure data integrity throughout the data lifecycle with administrative tools designed to provide full traceability.
File management should be stress-free. Chromeleon CDS features an intuitive file management tree coupled with scheduler-enabled archival tools and flexible-file-type exporting capabilities.
Data review is often a very time-consuming activity. Chromeleon CDS offers complete ALCOA+ traceability with tools to supplement and support best-practice data review workflows.
The International Council for Harmonisation (ICH) has updated its guidelines Q2 and added Q14 to cover method lifecycle from development to validation with the emphasis for analytical scientists to focus on incorporating a quality mindset through method lifecycle.
Learn about the comprehensive compliance features in Chromeleon CDS and how they align with current and potential requirements for audit review.
Uncover and reexamine data integrity principles established by ALCOA++ with an emphasis on carrying those principles into electronic records.
Learn from a compliance expert about Pharma 4.0 and how to make compliance and audit trail review easier through increased visibility and transparency.
This simple how-to demonstrates audit trail locations and how to set up audit trail event highlighting for easy review.
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