Starting point
Four labs operated Thermo Scientific Chromeleon as a chromatography data system locally. Methods, user accounts and sequence archives had drifted apart. More than 30 TB of data and over 20 validation servers made every configuration change a data-integrity and auditability risk.
For QA and IT, such island solutions create a typical GxP risk: identical processes run differently, permissions are not comparable and historic sequence data is hard to find. The client needed central administration that scales internationally without compromising the validated state.
Approach
cube one planned and operated a central Chromeleon landscape with unified user management, controlled migrations and end-to-end auditability.
Consolidating servers and databases
- Built a production landscape of six application servers and three SQL database servers including validation infrastructure with more than 20 servers.
- Safely transferred 400 GB of legacy data from four migrations to central servers with documented change control.
- Role model for 300 users with unified management across all labs.
- Remote access via MS Terminal Server without performance loss.
Operations: IT administration. Evidence: computer system validation.
International expansion and operational security
- Integrated Mexico site expansion into existing administration.
- Implemented permissions, backup and monitoring concept for the central landscape.
- Delivered feature requests and ensured system operation under GxP requirements.
Related: Databridge SoftMax / LabWare and system virtualisation.
Outcome
Simplified IT administration
- IT administration significantly simplified; ongoing management effort permanently reduced.
- Unified user management across all labs.
- International system growth without parallel island solutions.
Data integrity and auditability
- End-to-end auditability and permanent data availability across 30+ TB of sequence data.
- System meets data-integrity requirements; changes through change control.
- Sequence data stays findable; validated state is inspection-ready.
Four islands became one operating model. Related: Databridge SoftMax / LabWare and system virtualisation.