Navigating changes in a regulated software environment
Hear experts dive deep into the regulatory landscape, sharing considerations for aligning software records with ALCOA+ principles.
For those performing and perfecting pharmaceutical testing, the selection of a Chromatography Data System (CDS) can have an immense impact on the effort spent acquiring, processing, and reporting data. Any software with features that can reduce method development time, deviations, re-analysis, and the time spent in the data review cycle all while remaining intuitive for the users offers a huge return on investment.
Learn how Thermo Scientific Chromeleon 7.3.2 Chromatography Data System (CDS) can increase routine testing efficiency by up to 33% , provide gold-standard data integrity features, and still offer a straightforward solution built for users to develop, qualify, validate, and utilize analytical methods.
What are users saying?
"As a method development scientist, my day-to-day tasks are directly affected by Chromeleon Software. Chromeleon allows me to successfully design and perform analytical procedures, control multiple instruments simultaneously from one central computer, and monitor data in real time to facilitate study design. Time is everything in method development, and Chromeleon saves me time and allows studies to progress more smoothly and efficiently than they would without the software."
- Research Scientist, Charles River Laboratories
Achieve fewer failed runs and out of specification results through:
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.
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.
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.
Hear experts dive deep into the regulatory landscape, sharing considerations for aligning software records with ALCOA+ principles.
Australian-based Ego Pharmaceutical shares the process they used to select their laboratory software - Chromeleon CDS.
A scientific vendor’s perspective on recent trends in regulations and the potential future direction for the industry.
Learn about changes coming to the analytical method lifecycle regulations and discover tools to support methods from development to validation.
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