SIMATIC SIPAT: our PAT software
Compliance with legal requirements and 21 CFR Part 11
SIMATIC SIPAT 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
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.
One interface for all PAT tools
SIMATIC SIPAT can be combined with different analytical devices and provides comprehensive functions for the configuration and control of measuring devices. SIMATIC SIPAT collects all device data and controls the performance of the devices. The user benefits from a uniform interface for different analytical devices, for example, through easier training and operation.
SIPAT can be used in combination with the most popular process analyzers in production, in research and development, and in process development. Open industry standards are used for the reliable measurement, collection, and transfer of information and for exchange with third-party systems such as process control systems. SIPAT also considers offline or online quality parameters that are either collected in a laboratory information management system (LIMS), entered manually in the Supervisory Control and Data Acquisition (SCADA) system, or entered directly in SIPAT. Data from different sources or even from different sites can be consolidated for better evaluation.
Models can be created and used on different levels with SIPAT to achieve a specific model hierarchy for efficient data processing.
In the model builder, the user can initiate the preprocessing, validation, and analysis of the data. These data are then used to construct or to validate new or improved models. The models are stored in the SIPAT database with the corresponding version and status information.
Monitoring and control
The SIPAT runtime module combines online data collection with the alignment of the data with online prediction for quality parameters. SIPAT is responsible for the quality aspects of the process and provides the relevant information to the control system. The control system can then carry out the necessary control and corrective measures. The visualization of the SIPAT prediction can be realized via the SIPAT graphical user interface or can be integrated into the existing SCADA architecture.
All critical quality parameters (or critical quality attributes, CQA) can be monitored online and transferred to the control system.
SIPAT stores all data measured and calculated during the execution of a PAT (Process Analytical Technology) process together with the available information. These data are available to any logging tool and can be easily integrated in Office applications. The integrated SIPAT model builder and the SIPAT report manager make it possible to search, filter, and request measuring data, including context and calibration data, so that all necessary information can be used in the modeling software packages selected.