BIOVIA Total Quality ONE Quality Lab Industry Process Experience
Compliant Solution for Documenting Quality Testing Workflows and Outcomes
Quality Testing is often seen as a bottleneck in the product release process. Typical Quality Testing processes are paper based, disjointed, and cumbersome. At the same time, it is highly visible and heavily scrutinized both internally and externally by the FDA. Companies need a better Quality Testing strategy in order to stay competitive in the industry and continue to grow without increasing compliance risks.
BIOVIA’s ONE Quality Lab Industry Process Experience helps alleviate the bottleneck by replacing error-prone, paper-based systems with a solution that integrates directly with instruments and other systems, dramatically decreasing compliance risks and shortening release cycle times.
BIOVIA ONE Quality Lab supports the full workflow of quality testing from test requests to the creation of certificates of analysis including the direct data transfer from ERP and LIMS, consumables and instrument inventory and the lab equipment itself to the transmission of results for final release.
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The ONE Quality Lab helps Life Sciences organizations to increase productivity and efficiency, reduce costs and improve regulatory compliance ultimately making better decisions faster, reducing cycle times and accelerating product releases.
ONE Quality Lab Provides:
Automated transfer of sample information and results to and from ERP systems
Integrated consumables inventory and instrument metrology, including availability and fit-for-use checks
Enforcement of current procedures
Electronic documentation of analytical test methods and SOPs with audit trails
Electronic capture of data and meta data from laboratory instrumentation within the context of the actual test
Management of laboratory consumables and instrumentation
Sample processing and tracking
Electronic Data Review with "Approve-at-a-Glance" via dashboards with compliance flags for deviations
ONE Quality Lab Value:
Increased compliance with regulations and guidelines
Reduced manufacturing and operating costs
Improved productivity by >25%
Reduced QC cycle times by up to 50%
The BIOVIA ONE Quality Lab solution is part of BIOVIA’s comprehensive Total Quality Strategy that will support organizations to increase efficiency, reduce costs and improve compliance by covering all relevant aspects including definition, documentation, submission, execution, monitoring and management of all quality relevant tasks and information.