Compliance with legal requirements and 21 CFR Part 11
SIMATIC SIPAT and PharmaMV provides a comprehensive audit functionality, which enables compliance with legal requirements and 21 CFR Part 11. The most important audit function blocks of the software are as follows:
• System safety and authorization controls
• Electronic signatures
• Recording of all changes to data sets
• Recording of reports and reproducibility in the online database and in the archived data
• Version control for objects such as PAT methods, models, device settings, etc.
KEY FEATURES:
PAT CALIBRATION MODELS
Calibration model development and execution using the PharmaMV engines integrated into SIPAT. Flexible preprocessing, model building and traceability tools. Calibration models developed for Critical Quality Attributes such as drug potency.
PROCESS MODELS
Mechanistic( via gPROMS) and empirical steady state and dynamic models for soft sensors, monitoring, control and optimisation, executed open( Advisory Mode) or closed loop. Continuous and batch models, parametric and non-parametric options.
All model parameters, predictions, performance metrics available via intuitive user interface. Models developed for CDC, TSWG and FBD process units.
PROCESS MONITORING using SPC, MVSPC
Real Time Shewhart, EWMA and CUSUM charts with Western Electric Rules, automated Outlier detection and alarming.
Full suite of templates for multivariate process monitors using Principal Component Analysis, Partial Least Squares, with Multivariable Alarm Thresholds for the ConsiGma Units. MVSPC plots with SPE & T2 statistics provided for real time monitoring. Complete Multi-Model Operating Modes, Fault Fingerprints, Fault Diagnosis tools developed for the ConsiGma Units. Full integration with GEA’ s platform.
DATA VISUALISATION
Univariate and multivariate visualisation tools including SPC charts, contribution / score plots, trends, built to support process monitoring and control. These visualisations can be added to HTML5 dashboards and embedded in the GEA SCADA.
CONTROL ENGINEERING
Full integration with GEA’ s Dynamic Process Control interface with recipe-driven support for Advanced Process Control.
Model Predictive Control and optimisation is available for key process units in the ConsiGma line.
PharmaMV APC provides combined feedback and feedforward control of predicted Critical Quality Attributes using PAT derived or mechanistic models.
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