PAS-X
With PAS-X, Werum offers a mature standard software product for the highly regulated and batch-oriented process industries. The PAS-X MES provides out-of-the-box maximum standard functionality for all applications in the pharmaceutical and biopharmaceutical sector. Companies using PAS-X benefit from lean production and operational excellence.
"Right First Time", "Review by Exception", "Paperless Production", "Electronic Batch Recording", "Faster Time to Market", "FDA Compliance" – these are only some of the benefits of using Werum`s out-of-the-box MES software product PAS-X for your pharmaceutical and biopharmaceutical production.
PAS-X is the market-leading MES (manufacturing execution system) for the pharma and biotech industries. It is run by more than 50 percent of the world’s top 30 pharmaceutical and biotech companies and in about 800 installations around the globe.
PAS-X is developed in strict accordance with legal requirements such as FDA 21 CFR Part 211 and Part 11, EU GMP and GAMP 5 guidelines. By implementing our MES software product in your manufacturing processes, you benefit from high quality and significant cost savings. In most cases, a return on investment is achieved within two or three years.
- Quality by design
- Paperless production
- Electronic Batch Recording (EBR)
- Accelerated batch release times
- Shorter lead times
- Fast, reliable and secure data entry
- Efficient equipment management
- Improved process security
- Live monitoring of production
- High "Right First Time"
The PAS-X MES supports all major pharmaceutical industry segments, e.g. for vaccines, biopharmaceuticals, solids, liquids and other manufacturing operations.
PAS-X covers the product lifecycle in pharmaceutical and biopharmaceutical manufacturing from process development to commercial production and packaging.
Werum’s PAS-X software product including the development process meets all requirements set forth by the approving authorities for operating computer systems in regulated industries. PAS-X functionality complies with regulatory requirements, such as the ones set forth in the EU GMP guidelines including the GMP Annex 11 for Computerized Systems Guidelines and the FDA guidelines 21 CFR Part 11 and 21 CFR Part 210/211.
Our software development life cycle follows the risk-based approach described in the ISPE GAMP 5 guideline (Category 4 - Configurable Products).
Werum has excellent relations with validation consultants. Also, Werum is a member of the ISPE, the GAMP Supplier Forum, the GAMP D-A-CH Forum, and other organizations. In this vein, we are actively involved in current hot issues and are always up-to-date on the newest developments.
Werum is audited by its customers. This way, our customers can see for themselves that the quality of our processes satisfies all their standards. Some of our customers joined forces to carry out common audits on a regular basis. As a result, redundancies during the preparation, execution, and post-processing of the audits can be avoided for all parties involved and the auditing efforts can be reduced.
Werum is DIN EN ISO 9001-certified. Our customers can be sure that we keep our certification up-to-date so that they know that our work is always based on a solid, well-established quality management system.
Werum’s quality management focuses specifically on the Software Development Lifecycle (SDLC) of our PAS-X projects. Our software development process follows a clearly structured, high-quality procedure providing detailed evidence of all development activities. This complex process is supported by ProQuMaS, our Project Quality Management System. It ensures that any changes in the SDLC documents and the related test cases are recorded to enable traceability. Thus, our customers can trust in the high quality of our software.
The great number of PAS-X standard interfaces accelerates implementation projects and ensures seamless information exchange with all surrounding IT and production systems. Werum customers benefit from clearly defined PAS-X standard interfaces, through which PAS-X is horizontally and vertically integrated into their IT infrastructure. Integrated IT and production systems are a prerequisite for benefiting from production strategies such as Lean Production, Six Sigma, Performance Monitoring or Right-First-Time.
Werum uses the interface definitions of international industry standards (OPC, XML, etc.). Werum complies with the ANSI/ISA 95 and ANSI/ISA 88 standards regarding the functional assignment of tasks to different levels.
Werum offers certified, preconfigured interfaces working with market-leading ERP systems in the pharmaceutical industry. This way, PAS-X provides the link between the enterprise management system and the automation and equipment level.
PAS-X has standard interfaces to a great number of SCADA/Batch/DCS systems. Integration with the automation level allows a continuous information flow and an efficient control of the equipment. In cooperation with Seidenader solutions for these levels come from a single source.
As a standard feature, PAS-X integration capability provides for synchronization between MBR elements and LIMS activities. Typical elements for integration are sampling activities and storing of IPC results.
PAS-X integrates Document Management Systems (DMS) in order to save and store printed manufacturing reports, reference SOPs for display during the actual manufacturing process and consolidate manufacturing reports with documents from other systems (e.g. logs from testing equipment).