Manufacturing execution systemPAS-X MES for the pharmaceutical industry
Werum PAS-X MES (hereinafter referred to as PAS-X) is a manufacturing execution system specialized for the pharmaceutical industry provided by Kerber Pharma, Germany.
PAS-X covers all major lifecycle stages in pharmaceutical and biopharmaceutical manufacturing, from process development to product manufacturing and packaging. We support all major segments of the pharmaceutical manufacturing industry, including vaccines, biopharmaceuticals, solid formulations, and liquid formulations.
As an authorized PAS-X service partner, B-EN-G supports the implementation of PAS-X.
overview
Many pharmaceutical manufacturing industries are faced with the dilemma of not being able to transition from paper forms to electronic forms at manufacturing sites due to concerns about handling audit trails.
In this context, PAS-X has been developed in compliance with legal requirements such as FDA 21 CFR Part 211 and Part 11, EU GMP and GAMP 5 guidelines, and is therefore recognized by the top 30 pharmaceutical manufacturers in the world. In addition to over half of the companies in Japan, it is also used by many small and medium-sized pharmaceutical manufacturers.
By introducing PAS-X and changing from paper-based operations to electronic operations, efficiency and compliance will improve.
Realized by introducing PAS-X
PAS-X function group
PAS-X implements the business requirements specific to the pharmaceutical and biotechnology industries as standard functions, provides a set of standardized functions for these industries, and enables MES startup in a short period of time.
- PAS-X function
- Multiple modules available, combine standard features to suit customer needs
- PAS-X content
- Save time with industry best practice templates
- PAS-X service package
- Accelerating MES introduction
Toward the realization of Pharma 4.0, B-EN-G will make appropriate introduction proposals while taking into account the customer's situation and priorities.
| [Example of implementation divided into phases] | |
|---|---|
| Phase 1 | Weighing management |
| Phase 2 | Electronic batch records, master batch records, raw material inventory management |
| Phase 3 | Equipment management, productivity evaluation |
Effects of introduction
- Increase process efficiency
- Improving manufacturing quality
- Monitor and enhance manufacturing capabilities
- Support for compliance with legal and regulatory requirements
- Reduce time to actual production
For a more detailed explanation of PAS-X, please see Kerber's page for pharma.
B-EN-G introduction support service
PAS-X uses an interface based on international industrial standards (OPC, XML, etc.), allowing for smooth connections with devices. It is also an integration certified application for SAP ERP.
B-EN-G has over 20 years of experience implementing SAP ERP in the pharmaceutical manufacturing industry and building vertically integrated systems, including the manufacturing execution area. Therefore, we are able to make proposals and implementation that fully utilize the functions of PAS-X MES, which is highly compatible with SAP ERP and SAP S/4HANA. Based on our deep understanding of pharmaceutical production operations, we provide consistent support from concept to system implementation and ongoing support.
Introduction example
Sakamoto Pharmaceutical Co., Ltd., Japan's only specialized glycerin manufacturer, has a new plant at its Senboku factory, which is a core manufacturing site for PAS-X external interface standardization 'Plug and Produce' and a handling solution point for B-EN-G. PAS-X was selected for the "2nd RG facility" which has a production capacity of 20,000 tons. We have strengthened compliance and gone paperless in pharmaceutical manufacturing. During the implementation process, B-EN-G also supported CSV (computer system validation).
For details on the case and to download the leaflet, please see the Sakamoto Pharmaceutical Co., Ltd. PAS-X introduction case study page.
Material download
- Manufacturing execution system “PAS-X MES” leaflet
Related solutions
Computerized system validation (CSV) support service
Support services for system assessment, development work, maintenance of operational procedures, and verification work for companies entering the pharmaceutical manufacturing industry and medical device field.