Ready to Go: complete MES out of the box
Process Development / IMP Manufacturing (PD)
PAS-X Process Development / IMP Manufacturing simplifies and speeds up the modeling of manufacturing processes for pre-clinical and clinical production. It covers process development activities in all areas of the pharmaceutical and biopharmaceutical industry including scale-up. This function is also available as an entry-level solution.
Master Batch Records (MBR)
PAS-X Master Batch Records allows the customer to easily set up and maintain libraries with standardized, reusable building blocks which can then be used to create an MBR. An easy-to-use graphical design tool simplifies the MBR creation. PAS-X MBR facilitates and simplifies workflows, shortening approval cycles and therefore drastically reducing associated documentation work. This function is also available as an entry-level solution.
PAS-X Finite Scheduling – now powered by sedApta’s Factory Scheduler, whose standard functions are seamlessly integrated into PAS-X MES – is covering the production planning process. The function enables the detailed scheduling of your production processes and resources with finite capacity, the optimization of production sequences as well as the management of materials and multi-scenario analyses. Benefit from a higher quality of scheduling results with real-time feedback, less implementation effort thanks to a pre-tested, out-of-the-box interface, joint master data management and high visibility across multi-tier networks to reduce inventory.
Weighing & Dispensing (WD)
The precise weighing and dispensing of input materials based on recipe specifications is the core of any pharmaceutical manufacturing process. Accurate data collection within this first processing step is fundamental to batch tracking and documentation. In a reliable and "easy-to-operate" way, PAS-X Weighing & Dispensing guides the user through the weighing process and provides the necessary support for compliance with safety regulations and recipes. It supports manual as well as automated weighing and dispensing operations. Many Werum customers start their electronic manufacturing projects with the WD function and scale up later according to their needs. This function is also available as an entry-level solution.
Electronic Batch Recording (EBR)
Efficient electronic batch documentation is one of the most important objectives in introducing an MES to pharmaceutical production. With PAS-X Electronic Batch Recording all MBRs are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X EBR ensures an error-free and guided execution of the entire production process and right-first-time manufacturing.
PAS-X Equipment Management administers and monitors cleaning procedures and statuses for all types of production-related objects. This includes MBRs and particular rules for cleaning scales, work rooms, containers, production equipment, setup parts and toolkits. Electronic paperless equipment logbooks keep status lists, cleaning rules and histories for individual container types.
Material Flow & Inventory
PAS-X Material Flow & Inventory secures in-plant material flow throughout the pharmaceutical manufacturing process. It contains sub functions for manual and automatic transport control as well as in-plant administration of shop floor storage areas.
PAS-X Warehouse Management supports production-related warehouse logistics. The system components can be configured as required, and form the basis for implementing warehouse management systems, control systems and picking systems.
Process Quality Control
PAS-X Process Quality Control captures events and deviations enabling companies to drastically reduce batch review and release time and to implement Review by Exception. It ensures a continuous monitoring of the production quality. In order to achieve the highest possible quality and to take preventative and flexible measures, PAS-X Process Quality Control supports process-analytical on-line, in-line, and at-line quality controls. The function supports the implementations of Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.
Track & Trace Serialization Aggregation (T&T)
PAS-X Track & Trace Serialization Aggregation enables the pharmaceutical industry to comply with anti-counterfeiting requirements for medical drugs. It provides serialization and aggregation functionality for packaging processes and integrates the ERP and the Global Repository with the shop floor packaging equipment and line controllers. PAS-X T&T delivers a comprehensive product-based functionality out of the box and supports the requirements of all relevant countries around the globe.
PAS-X Manufacturing Intelligence helps you to enhance the shop floor performance within your manufacturing processes. For instance, our PAS-X KPI Solution supports operators and supervisors on the shop floor as well as production site managers to constantly monitor operational performance data from the shop floor. The live monitoring of the production and packaging lines allows optimizing processes or equipment very quickly, thus boosting your operational performance. PAS-X KPI is also available as a lean standalone software solution for fast and easy implementation.
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