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 CDS 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

  •    Product support to build your system to meet your compliance requirements.
  • Security for your data with Automatic Network Failure Protection (NFP) and XVault.
  • Control for your users with >180 granular privilege capabilities.
  • Organization for your files in a customizable file tree with task scheduler and configurable rule management. 
  • Efficiency gains for your review cycle from centralized audit trails with configurable highlighting, reporting capabilities, and even exporting.
Compliance without compromise

Qualifying as part of validation

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.

  • Built-in qualification tools on software installation to get you started on your validation journey.
  • Validation services provide expert guidance to ensure fast, compliant implementation.
  • Standard IQ/OQ/PQ for control stations and instruments allow you to thoughtfully expand and maintain your system. 
Ensuring data integrity

Ensuring data security

Security is more than user password complexity. Ensure data integrity throughout the data lifecycle with administrative tools designed to provide full traceability.

  • Deliver continuous operation and data security with Automatic Network Failure Protection.
  • Control system and data access with rulesets, privileges, roles, groups and individual user accounts.
  • Ensure data quality with automated raw file verification.
Centralized administration

Simplifying data management

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.

  • Automate data organization by combining powerful injection queries with the Scheduler.
  • Seamlessly transfer data between systems such as Thermo Scientific Watson or SampleManager LIMS.
  • Manage backup and archival schedules to double-down on frustration free file management.
Simplify your laboratory information systems and data management

Facilitating data review

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.

  • Review-by-exception is supported by highlighting high-risk changes and capturing why actions were performed.
  • Streamline audit trail review with highlighting, filtering, and reporting tools at the system, instrument, and/or sequence level.
  • Visualize higher-risk method or integration changes with an intuitive comparison tool.
  • Meet electronic signature requirements with an up-to 3-stage sequence-level process with the ability for pre-run sequence approval.

Carrying Data Integrity into Electronic Records

Uncover and reexamine data integrity principals established by ALCOA++ with an emphasis on carrying those principals into electronic records.

Data integrity challenges

Learn from a compliance expert about Pharma 4.0 and how to make compliance and audit trail review easier through increased visibility and transparency.

Integrated Audit Trails

This simple how-to demonstrates audit trail locations and how to set up audit trail event highlighting for easy review.

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