MES
Technology Stack
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* The logos are copyrighted and owned by their respective owners / organizations.
MES
HITPHAMS (Pharma MES) –Hitachi Pharmaceutical Manufacturing Execution System is a packaged system designed to manage pharmaceutical and biotech manufacturing compliant with cGMP, EC-GMP, and J-GMP.
CIC is a high-productivity and high-quality software development company that established a vehement partnership with HITACHI Limited, a well-known Japanese multinational conglomerate that provides sophisticated business and consumer solutions that transform business processes. This consummate partnership platform supports pharmaceutical companies by implementing HITPHAMS to streamline and tighten their manufacturing operations to implement stricter manufacturing and quality controls according to global requirements.
HITPHAMS will convert the current Pharma manufacturing paper works electronically as eBMR, eBPR, and eLog Book.
HITPHAMS connects, monitor, and control complex manufacturing systems and data flow on the factory floor. And it will communicate with all GMP systems like ERP (SAP), LIMS, DMS, CLS, QMS, SCADA, and eDMS.
The main goal of HITPHAMS is to ensure the effective execution of manufacturing operations and improve production output. HITPHAMS Function is designed to meet ISA-95/ISO 62264 standards.
HITPHAMS exercises strict control over the production of high-quality, highly reliable pharmaceuticals within the framework of manufacturing instructions and manufacturing result records as designed for pharmaceuticals.
It helps to control the SOPs, confirm tasks, and execute approvals by the assigned representatives.
In HITPHAMS, users are empowered to create electronic batch reports, including attachments, using either tailor-made templates or established formats.
The Implementation typically covers the following functions
- Security
- Approval Management
- Calendar Management
- Error information handling
- Archival management
- Master Batch Record
- Workorder Management
- Manufacturing Management
- Inventory Management
- Quality Control
- Recipe management
- Weighing and dispensing
- In-process checks
- E-logbooks
- e-BMR & e-BPR
- ERP and other equipment integration
- Batch release
- Audit logs
- Deviation Management
Making your business ideas come true
The key benefits of HITPHAMS
- Compliance with latest global Good Manufacturing Principles (GMP) guidelines
- Strict Standard Operation Procedure (SOP) sequence implementation
- Promotion of accurate work
- Promotion of on-line and paperless operation
- CAPA and Complaint Handling.
- Improves the efficiency of creating analytical data records
- Reduce the risk of human error and minimize rework costs
- Tracking and traceability are ensured
- Paperless operations, data availability at a click of a button for surprise inspections
- Providing Quality and Data Integrity in Global Pharmaceutical Manufacturing.
- Offering the optimum system according to the scale
Strength of the OEM
- Well experienced pharmaceutical engineers to support the project.
- Vast experiences of implementing GMP related systems, eQMS, LIMS, SCADA, etc.
- No.1 IT service provider for Pharma Industry in Japan
- 70+ years History in Pharmaceutical Industry
- Hitachi has 22 years of experience in the Pharmaceutical MES area.
- Implementation of HITPHAMS: 140+ sites
- Hitachi hosts the most significant user conference in the pharmaceutical industry in Japan. Nearly 50 companies attend the annual meeting. The event provides an excellent opportunity to exchange ideas and discuss future requirements of HITPHAMS and solutions for compliance to “Good Practices.”
Success Stories
Customized by Objectives through an improved workflow
Features
To create a Windows Application for the CLS interface. Also, this specification explains the Data transfer details from CLS to MES based on requests
Solution
When a user logs in, MES makes a tokenized request to the web service, which response with the necessary data and a status response code. Successful integration has been achieved, and only qualified users are permitted to execute or update the SOP
.
Integration with the L2 equipments
Features
MES application integrates with the capable equipments using OPC connectivity. Each equipment’s host works as an OPC server and the MES application works as an OPC client to fetch the real-time data from Manufacturing Equipment.
Solution
The OPC connection is established between the equipment and MES application by configuring the IP address, Host Name, and Equipment OPC Tag Name for Real-time data retrieval. The Equipment and MES system should be in the same network. Based on the configuration, the system will identify the equipment host and fetch the tag value from the relevant host, enhancing the data integrity and avoiding manual interventions.
Biometrics in Production Area
Features
This specification explains the interface between the MES application and Biometrics used in the Pharma Division. Also, this specification describes the Data transfer details from Biometrics to the MES system.
Solution
The MES will send a request to the biometric database and get a response at the user login time. If MES receives an "In" status, it allows the user to log in to the application. If it gets "Out" status, it won't allow the user to log in and list the user's punch for the latest Date and Time. Using this feature, HIPHAMS controls unauthorized user logins.
Manual Record into Electronic Records
Features
In the MES System Manual Paper based batch records and logbooks records are maintained in real-time.
Solution
Paper-based batch records and logbooks are maintained as electronic batch records and E-logbooks. The e-BMR/e-BPR resembles the existing paper BMR and BPR template. So, documentation is automated in the MES system.
Integration with SAP
Features
Data linkage will be performed between SAP and MES using secured file transfer/middleware.
Solution
For File transfer, SFTP/ FTP (File Transfer Protocol) is used. Data received (inbound) in MES are Stock Information, Inspection results, and Work orders. Data sent (Outbound) from MES are Inventory Data, Work order completion Results, and operating hours. The operator can refer to transaction results about the linkage in MES.
Inventory Management
Features
Inventory management is the entire process of managing inventories from raw materials to finished products.
Solution
The allocation process will create an inventory of allocated materials used in other blocks. The material storage condition can be viewed to display the storage condition for each substance.