Built for compliance from the ground up, Thermo Scientific Chromeleon 7.3.1 Chromatography Data System (CDS) enables you to meet the latest regulatory requirements while still improving productivity. By offering QA/QC labs a complete solution for compliance and data integrity, Chromeleon Software provides you confidence in your data and results, reducing stress at the time of an audit.
Chromeleon CDS enables your laboratory to efficiently manage all your instruments, policies and users, while supporting the secure acquisition, processing, and storage of data in a single software platform. As part of a modern business IT system, it can easily scale to meet customer needs, from a few PCs in a single lab to a large network that spans hundreds of instruments over multiple continents, while still allowing the control necessary to meet regulatory requirements.
Learn how Chromeleon CDS gives you audit safety and delivers compliance, connectivity, productivity, and confidence to your laboratory.
What are users saying?
"We use Chromeleon within our testing lab in R&D, to process and move data around. It has been a great solution, in a fast paced environment, that keeps us compliant and efficient."
- Group Leader Product Integrity, Mary Kay
Compliance without compromise
Complying with regulations is a necessity in many chromatography labs. Historically, that has meant a reduction in efficiency due to the need for limiting privileges and searching for information during data review, but it doesn’t need to be this way.
- Controlled user access and permissions to ensure data integrity and compliance with GxP, 21 CFR Part 11 and Annex 11
- Multiple audit trails with versioning and electronic signatures track all activities within the CDS alongside specific processes on the local PC for easy tracking and review of changes
- A sequence-centered approach groups all relevant data in a single location, easing data review
- Audit Trail Events streamline audit trail review by alerting you to actions that may require investigation
Chromeleon CDS can help your validation efforts go smoothly with built-in Installation Qualification (IQ) and Operational Qualification (OQ) tools for the software as well as select Thermo Scientific hardware components. The built-in Performance Qualification (PQ) tools allow for periodic checks to verify the software and hardware are working as intended.
The extensive audit trails capture the who, what, when and why of actions performed, a vital requirement of validation activities. The powerful and easy-to-use audit trail search capabilities aid in the documentation of critical validation steps.
The Chromeleon Administration Console is the central access point for all administrative tasks, such as:
- Managing users, roles, privileges and access control
- Allocating and controlling licenses at a global and/or organizational unit (e.g. site, lab, department) level
- Defining global policies with controlled devolution of admin tasks to user administrators
- Managing Chromeleon Domain resources including servers, PCs and printers
Simplify your laboratory information systems and data management
Thermo Fisher Scientific has advanced informatics providing comprehensive coverage of all laboratory data management requirements, meeting your compliance requirements while increasing your data connectivity and productivity. Connecting your CDS and LIMS together under a single vendor streamlines workflows and enables data sharing.
- Automate data organization by combining powerful injection queries with the Scheduler tool
- Collate data based on any criteria; automatically move or archive it for optimal system organization and performance
- Export in FDA-approved formats
- Connect your CDS and LIMS software with out-of-the-box solutions from Thermo Fisher for seamless data flows
Ensuring data integrity
Chromeleon Software provides a unique, resilient architecture to prevent data loss or corruption during a network outage and ensure all actions are controlled and tracked to ensure data integrity.
- Automatic Network Failure Protection (NFP) using unique XVault technology ensures continuous operation and data security should network or central resources become unavailable
- All network-based resources required to ensure operation and compliance of the software are cached locally ensuring lab operation can be continued
- A comprehensive suite of tools and controls ensure the accuracy and consistency of data over its life cycle
Data integrity: Audit Trails with Ease of Review
Audit trails are an important regulatory requirement and a proven means of detecting data integrity issues. Learn how Chromeleon CDS controls and eases the review of audit trails.
Using Chromeleon CDS to Comply with 21 CFR Part 11
21 CFR Part 11 ensures electronic records are trustworthy, reliable and equivalent to paper records and handwritten signatures. Learn how Chromeleon CDS reduces effort to achieve compliance with built-in functionality.
Are you audit ready? Ensuring trustworthy data
This ebook will highlight resources that explain and illustrate the comprehensive compliance features in Chromeleon CDS and how those features align with current and potential future requirements for audit review.
Data integrity challenges for audit trail review and Pharma 4.0
Learn from a compliance expert about Pharma 4.0 and how to make compliance and audit trail review easier through increased visibility and transparency.
The evolutionary journey of Chromatography Data System
Learn how revolutionary HPLC technology from Thermo Fisher Scientific has changed and improved the science of HPLC over the last 35+ years.
On-demand webinar series: Built for Quality without compromise
This series shows, how modern CDS can provide a robust, reliable software platform from design and development, through offering the tools to maintain data integrity to easing qualification and validation.
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