PATware
Process Analytical Technology (PAT) has become a key role in FDA's initiative entitled
"Pharmaceutical cGMPs for the 21st Century: A Risk-Based approach". The PAT initiative is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. PAT enables more flexible production processes, improved quality and significant cost reductions.
HCL AXON helps you monitor the Pharmaceutical manufacturing processes better by using HCL AXON's PATWare, a solution accelerator built over SAP xMII for Process Analytical Technology related initiatives.
PATWare helps improve the Product Quality and reduce the Product Rework & Wastage. The key features include:
- Supports multiple roles
- Root Cause Analysis
- Data Analytics
- Master Data Management
- Integration with SAP ERP and Shop floor systems
Supports multiple roles
PATWare supports the following roles:
- End User / Shift QC Role - responsible for production execution, monitoring, root cause requisition, assignation, data analysis, etc
- PAT Admin Role - responsible for process sequence definition, approval /refer back of root causes, master data management, etc
Root Cause Analysis
PATWare supports root cause analysis for process parameters that exceed the defined threshold limits.
- Assignation of root cause - associate one of the pre-approved root cause to a process out-of-control situation
- Requisition for a new root cause in to the system for a particular process out-of-control situation
- Approval / Refer Back of root cause requests
Data Analytics
PATWare allows performing data analytics and viewing the information as charts, graphs and in tabular formats.
- Batch Data analysis can be done by applying filters on the following:
- Product Type
- Product
- Unit Operations
- Process Steps
- Batch Start and End dates
Master Data Management
PATWare supports for management of master data either using a relational database like MS SQL Server or an existing ERP system like SAP ERP. Master Data managed currently includes:
- Site & Equipment information
- Product & Product Type information
- Batch information
- Process Sequence (Unit Operations, Process Steps, Process Parameters, Process Thresholds)
Integration Landscape
PATWare provides support for integration with external systems like ERP, MES, Control Systems, Data Historian by leveraging on the Connectors provided by the SAP xMII software.
Master information available in the different SAP ERP modules like PP, PP-PI, QM, PM can be used by the PATWare Application or else sent downstream to MES, Controls Systems, Field Devices, etc. PATWare updates real time or near real time information in SAP ERP. PATWare has the capability to work in situations where no ERP system exists and all the master information needs to be maintained as part of a relational database.
