Werum PAS-X MES, by Körber Pharma, is the world's leading Manufacturing Execution System (MES) software suite specifically designed for highly regulated, batch-oriented process industries like pharmaceutical, biopharmaceutical, and cell & gene therapy manufacturing. It is a modular, standard software product that provides comprehensive, out-of-the-box functionality for the entire production lifecycle, from process development to commercial production and packaging.
Key Benefits and Value Proposition:
- Compliance & Data Integrity: Developed in strict accordance with legal requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 guidelines, it ensures full audit trails, electronic signatures, and paperless, compliant documentation.
- Right-First-Time Manufacturing: The system guides users through the entire manufacturing process, reducing human error and significantly increasing the proportion of processes that are executed correctly on the first attempt.
- Efficiency & Digitalization: It replaces time-consuming, error-prone paper-based processes (like Master Batch Records) with electronic execution and documentation, accelerating work processes and shortening approval cycles.
- Scalability: PAS-X is tailored to meet the needs of all enterprise scales, from mid-sized and regional manufacturers to large global pharmaceutical corporations, with both on-premise and cloud-based (PAS-X as a Service) deployment options.
Main Features and Capabilities:
- Electronic Batch Recording (EBR): Digital execution and documentation of Master Batch Records (MBRs).
- Master Batch Records (MBR): Tools to easily create, maintain, and manage standardized, reusable recipe building blocks using a graphical design tool.
- Weighing & Dispensing: Guides and documents precise weighing and dispensing operations, supporting both manual and automated processes.
- Packaging: Includes functions for Electronic Batch Recording, Overall Equipment Effectiveness (OEE) monitoring, and serialization/aggregation via Track & Trace (T&T).
- Equipment Management: Administers and monitors cleaning procedures and statuses for production-related objects.
- Process Quality Control: Continuously monitors production quality, records deviations, and supports 'review-by-exception' processes.
- PAS-X Savvy Suite: Offers additional products for data management and analysis, forming a basis for the use of AI in production.