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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