If you work in pharmaceutical QC or Development, compliance and data integrity are a top priority. However, you also need to reduce the amount of time spent analyzing samples and nothing has a bigger effect on this than spending time re-running samples due to out-of-specification deviations or performing thorough batch release reviews. Thermo Scientific Chromeleon 7.3.1 Chromatography Data System (CDS) can help you with both. With features designed to increase efficiency by up to 33%, while providing gold standard compliance and data integrity features, Chromeleon CDS makes it easier than ever to drive efficiency gains and achieve, monitor, and demonstrate compliance.
Built for productivity: Reduced downtime and up to 33% increased efficiency
Achieve fewer failed runs and out of specification results through:
- A modern architecture to reduce clicks and windows delivering proven productivity gains
- Pre-injection sequence ready checks, with active solvent level monitoring for Thermo Scientific Vanquish Core HPLC instruments
- Real-time in-run evaluation of System Suitability Tests with Intelligent Run Control for result-based reactions
- Enhanced universal eWorkflow procedures simplifying adherence to SOPs
- Spreadsheet-based report templates to calculate the final results inside the CDS
Built for compliance: Approach your inspections with confidence
- Complete suite of compliance features capable of meeting 21 CFR Part 11/Annex 11 regulations, as well as FDA, EMA, MHRA, and PIC/S data integrity guidelines
- Configurable, so you can comply with regulatory guidelines and your internal processes
- Powerful, yet still easy to use
- Audit trail events and queries quickly and clearly present the info needed
- Versioning shows how changes have affected results
Built for nitrosamines: Confidence in compliance. Confidence in results.
Thermo Scientific delivers optimal MS solutions for nitrosamine impurity analysis, operated by Chromeleon Software, delivering confidence in results whichever direction your laboratory takes.
Accurate identification for robust analyte monitoring and high-throughput screening, with compliant control and data processing for LC and GC high resolution accurate mass, and triple quadruple MS instruments.
Built for oligonucleotides: Robust, accurate characterization
Combined with the Thermo Scientific Vanquish UHPLC systems, which provide biocompatibility with state-of-the-art solvent blending and a focus on uptime, robustness and reliability, Chromeleon CDS delivers operational simplicity to your oligonucleotide analyses to deliver new benchmarks in accuracy, precision, sensitivity, and ease of use.
Built for extractables and leachables: Advanced techniques for testing
Extractable and leachable (E&L) studies require a wide range of chromatography techniques in order to cover all potential entities. Chromeleon CDS controls over 540 Thermo Scientific (LC, GC, IC and MS) and third-party instruments, needed for a full E&L study. Containing all the capabilities needed to handle identification and quantification of known and unknown peaks, including the ability to search MS libraries and quantitate vs response factors, plus it has a complete set of compliance features to meet regulatory requirements.
Built for VOCs and residual solvents: Streamline your laboratory workflows
Run your routine GC or GC-MS VOC and residual solvent analyses in an enterprise environment – from method creation to final reporting. Download the USP <467> eWorkflow procedure directly from the Thermo Scientific AppsLab Library of Analytical Applications for a complete method and consumables shopping list in one click. Chromeleon Software delivers superior instrument control, automation, and data processing for compliant VOC and residual solvents analysis.
Compliance-ready MS for Pharma
Explore real use cases of how a networked CDS is the best choice for data acquisition and processing for quantitative LC-MS analyses and for ensuring business efficiency, regulatory compliance, and data integrity.
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.
Applications and workflows
Compliance, data integrity and security
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