An out of the box solution to meet FDA requirements for CPV
Automate data collection and analysis for CPV – instant access to current and historical data
Improve process understanding and controlling process variability
Understand the correlation of Critical parameters and there affects.
Real-time Monitoring of adherence to control and specification limits
Automated Statistical analysis of data
Automate APR and CPV Reports
Move from reactive analysis to proactive analysis
Huge data gathering time and costs savings
PI based Continuous and Batch Data retrieval. Also, used with Event Frames or can take data from PASX directly
Integrated to LIMS for Quality Data
Integrated to SAP for Batch Meta Data and Batch Approval information (via third party applications)
AF Centralized configuration for CPV parameters – Recipe based approach for definining your recipe, data retrieval specifications and calculations in AF, copy and paste for the addition of new Countries / Sites / Products. Data is automatically picked up and analysed via the Livepoint CPV engine, and is easily extended by users to add new processes or products for analysis
Ease of extendibility – no need to modify control system configuration and associated costs
Integrated to R for statistical analysis
Notifications of process drifts or breaches
Full approval/review workflows and option for user commenting / rejects etc.
Full reporting capabilities – Batch / Quarterly and APR reports
Full audit trail and Part 11 compliant
Saves over 1 month worth of man-hours per quarter on quarterly reports data gathering alone
Puts data in the hands of process specialists in real time to monitor and control the process as it is executed.