What is HITPHAMS?
HITPHAMS (Hitachi Pharmaceutical Manufacturing Execution System) is a manufacturing management and quality control system that connects manufacturing site and quality control operations with management. It is equipped with an extensive range of standard features to drive digitalization.
It supports everything from centralized management of manufacturing and quality records to effective data utilization.
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- ERP : Enterprise Resource Planning
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- MBR : Master Batch Record
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- EBR : Electric Batch Record
Scope of service provision
HITPHAMS can support everything from system building through concept development, preparation, and operation.
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- SOP : Standard Operating Procedures
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- CSV : Computer System Validation
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- VP : Validation Plan
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- URS : User Requirement Specification
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- FS : Functional Specification
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- DS : Design Specification
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- DQ : Design Qualification
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- FAT : Factory Acceptance Test
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- IQ : Installation Qualification
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- OQ : Operation Qualification
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- PQ : Performance Qualification
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- VR : Validation Report
Example business process flow and system scope
Achieve improved operational quality and continuity through OT×IT.
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- GQP : Good Quality Practice
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- CAPA : Corrective Action; Preventive Action
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- OOS : Out of Specification
Example system configuration
HITPHAMS enables flexible system building, from standalone solutions to integrated management systems, tailored to manufacturing sites.
List of features
HITPHAMS is an all-in-one package equipped with all the features necessary for manufacturing management and quality control.
It maintains features that support the manufacture of conventional low-molecular-weight pharmaceuticals, as well as biopharmaceuticals and regenerative medicine products.
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- AGV : Automated Guided Vehicle
- *TrackWise is a registered trademark or trademark of Sparta Systems, Inc. in the United States and other countries.
- *Nymi Band is a wearable biometric authentication device developed by Nymi Inc. of Canada.
- *Other company names, product names, etc. are registered trademarks or trademarks of their respective companies.
