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New SmartLab Version 3.0 software from VelQuest Corporation provides analytical and QC labs in cGMP environments with compliant high volume test method calculations and reporting automation with IT system integration tools. The only "method-centric" automated lab compliance software platform, SmartLab3 is useful in reducing overall QC/QA cycle times for lot and batch release of pharmaceutical products. It is available immediately for upgrades or new installations.
"With SmartLab3, quality control and analytical development labs in regulated environments can eliminate the non-value added and often error prone paper-based processes, and improve lot and batch cycle times to product release by 30-50%," said Bill Buote, Chief Technology Officer of VelQuest. Through this new platform architecture, SmartLab3 users can realize the value of a single click of the mouse button to improve lab productivity and reduce operational QC/QA costs, ensure compliance with cGMP requirements at the test-method level, and provide an interoperable data management platform for seamless integration of all existing IT technologies used in the QC/QA lab environment.
With the release of SmartLab3, users can now execute blocks of calculations, carbon copying, and record transfers, significantly improving ease of use and reducing data collection and review cycle times. "Initial users report dramatic elimination of time to produce reports and perform calculations specifically with regards to CDS (Chromatography Data Systems) which is traditionally a manual process", said Ken Rapp, President and CEO of VelQuest. A new "pick and choose" search environment completely eliminates the labor intensive paper output. In addition, Version 3.0 provides all critical method data records to be accessed by QA reviewers in a new data pivot table to streamline method/process investigations and audits. Users report a 50-70% reduction in supervisory and peer review times.
Access to the SmartLab platform is controlled via a secure and granular privilege grid with full audit trails and electronic signature capabilities, providing full compliance with the FDA's 21CFR Part 11 regulations. The result data is fully accessible to any authorized member of the management team. Customized reports, including Certificates of Analysis for batch release documents, can then be automatically created and approved. Data and trending reports can also be exported to other in-house IT programs through a universal XML-based data exchange facility. In many respects, this technology represents the "process analytical technology" (PAT) applied to QC laboratory processes.
Print page"With SmartLab3, quality control and analytical development labs in regulated environments can eliminate the non-value added and often error prone paper-based processes, and improve lot and batch cycle times to product release by 30-50%," said Bill Buote, Chief Technology Officer of VelQuest. Through this new platform architecture, SmartLab3 users can realize the value of a single click of the mouse button to improve lab productivity and reduce operational QC/QA costs, ensure compliance with cGMP requirements at the test-method level, and provide an interoperable data management platform for seamless integration of all existing IT technologies used in the QC/QA lab environment.
With the release of SmartLab3, users can now execute blocks of calculations, carbon copying, and record transfers, significantly improving ease of use and reducing data collection and review cycle times. "Initial users report dramatic elimination of time to produce reports and perform calculations specifically with regards to CDS (Chromatography Data Systems) which is traditionally a manual process", said Ken Rapp, President and CEO of VelQuest. A new "pick and choose" search environment completely eliminates the labor intensive paper output. In addition, Version 3.0 provides all critical method data records to be accessed by QA reviewers in a new data pivot table to streamline method/process investigations and audits. Users report a 50-70% reduction in supervisory and peer review times.
Access to the SmartLab platform is controlled via a secure and granular privilege grid with full audit trails and electronic signature capabilities, providing full compliance with the FDA's 21CFR Part 11 regulations. The result data is fully accessible to any authorized member of the management team. Customized reports, including Certificates of Analysis for batch release documents, can then be automatically created and approved. Data and trending reports can also be exported to other in-house IT programs through a universal XML-based data exchange facility. In many respects, this technology represents the "process analytical technology" (PAT) applied to QC laboratory processes.
Company Information
25 South Street
Hopkinton, Mass. 01748 (see map)
Contact Name: John P. Helfrich
Phone: (508) 497-0128
email: john.helfrich@velquest.com
Website: www.velquest.com
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