SIPAT (Siemens PAT Solution)
Source: Siemens Industry, Inc.
The direct path to the perfect batch: Our PAT software SIPAT ensures optimum process performance and integrated quality in the pharmaceutical industry. The PAT software SIPAT is fully compliant with the FDA initiative "Pharmaceutical Manufacturing in the 21st Century” that fosters implementing process analytical technology (PAT).
SIPAT is the Siemens' software solution to support PAT (Process Analytical Technology) implementation efforts and use of PAT tools in development and manufacturing. SIPAT enables the increase of process understanding and allows continuous process improvement during manufacturing operations and process development.
SIPAT's Main Features:
- Data collection : capture process analytical and process data
- Data mining : like MVDA (Multivariate Data Analysis) model creation and validation
- Real-time prediction of quality parameters
- Allows the application of PAT in the broad sense : monitoring and control
- A common interface for all PAT tools (process analyzers, data mining tools…) reducing complexity, allowing standardization and assuring ease of operation
- Can be used in manufacturing and development
- Allows a modular & scalable architecture (allowing a scalable PAT roll-out)
- Supports easy and fast process validation
- 21 CFR 11 ready, version management, raw data storage, user access rights
- Online visualization as well as reporting and analysis of historical data
- Integration to both existing and new infrastructures like PCS, Batch Engine, MES, LIMS, data portals, knowledge management systems.
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