Automate Sample Preparation Data for Chromeleon CDS
VelQuest Corporation, the developer of the SmartLab GMP Lab Execution System and ELN, announced today the availability of their SmartLab CDS Adapter for Chromeleon. This Adapter is a comprehensive sample preparation data input and post-run systems integration product designed for the requirements of today’s paperless cGMP
development and quality labs.
Developed at the request of a global pharmaceutical company that is deploying VelQuest’s SmartLab GMP Lab Execution System and ELN to its global manufacturing QC lab sites, the Chromeleon Adapter is powered by SmartLab technology and automatically ports critical sample preparation data from SmartLab and forwards the information directly to the sequence set in the Chromeleon workstation. The adapter also provides post run automated evaluation, calculation and integration to any output target application such as a lab report, ERP system or commercial LIMS. The application is non-invasive to the CDS operation. This new integration product reduces the analyst’s pre and post CDS run workload from hours/day to minutes and provides a seamless integration platform for the Chromeleon CDS to any LIMS or ERP system.
The significant productivity and compliance benefits include:
• Reduction of analysts’ workload for post-run CDS operations from hours/day to minutes.
• Automated sample preparation data transfer to the CDS sequence set.
• Automated peak count assessments to eliminate the risk of missed degradation products or impurities in the samples with automated restatement of results.
• Automated and validated calculations (including LLQ values) remove the risk of any human error in this important quality assessment operation in GMP areas.
• Automated (and validated) data transfer to a final report (in-house or LIMS) eliminates transcription errors and the need for time consuming peer review processes.
• The CDS Adapter for Chromeleon is powered by the SmartLab core system, where additional method-based applications like reagent preparation procedures and analytical test methods can be added at any time to complete a full GMP Electronic Notebook System.
“Today, quality control and analytical development labs in regulated environments can eliminate the non-valued added, time consuming and often error prone paper-based processes, and improve compliant data management integration processes”, said John Helfrich, Vice President, GMP Automation Programs at VelQuest Corporation. “Through this innovative technology, the SmartLab CDS Adapter for Chromeleon enables the CDS input and output data elements and IT infrastructure integration to be truly seamless and fully compliant with modern pharmaceutical regulatory requirements. The product configuration minimizes the amount of time analysts spend
transcribing sample prep information into the CDS system and performing paper-based calculations with redundant checking from traditional use of the Chromeleon CDS system. In addition, since the CDS Adapter for Chromeleon is powered by the SmartLab core, it is extensible
to be configured as a complete SmartLab GMP Lab Execution System.”
“This adapter will be of use to many customers who are looking to integrate Chromeleon chromatography data with information from other analytical instruments”, said Fraser McLeod, Director of Product Marketing for the Dionex Life Sciences Business Unit. “By combining the innovative technologies of both Chromeleon and SmartLab, customers will quickly see significant productivity gains, generate higher quality analytical data first time, and more easily meet regulatory requirements.”
VelQuest’s new SmartLab CDS Adapter for Chromeleon is available with full install, training and validation services to go-live in cGMP operations in an estimated 45 day time period.