Laboratories working with Process Analytical Technology (PAT) to control manufacturing quality can benefit from the QA/QC, data generation and analysis, and SOP management provided by the Core LIMS. The system allows labs to generate products more efficiently, saving time and money, while increasing their product quality.
The Core LIMS is instrument independent, allowing for the integration of any instrument for automatic data collection and results flagging. It supports multivariate data analysis, process monitoring and control, and labs� knowledge management. The Core system facilitates compliance with regulatory bodies such as the FDA, and provides full traceability for each data point, mouse-click, document version, etc. in the system for transparent auditability.
Core Informatics can create integration with any of a client�s other software or systems. This provides a unified platform from which users can access data collected from any instrument or tool, simplifying the reporting and analysis of a PAT lab�s data for decision-making support. The Core system monitors processes through every step, allowing for early detection of problems or abnormalities through the generation of automatic alerts based on admin- or user-defined thresholds.
� Instrument
integration for data collection automation
� Automatic results reduction
& flagging
� QA/QC
� Automatic alerts based on thresholds, authorization, publishing
� Integration with third party systems (ERP/MRP/accounting etc.)
� Project management
� Workflows management
� Worklist management
� Customized automatic & ad hoc reporting
� Work allocation & scheduling to reduce bottlenecks
� Product life cycle management (testing, tracking, quality checking)
� Reduce production cycles & time to market
� Barcode, RFID compatible
� SOP & protocol management
� Regulatory compliance with 21 CFR Part 11, GMP, etc.
� Multivariate data analysis