Werum PAS-X is a mature standard software product for highly regulated and batch-oriented process industries. The PAS-X MES (Manufacturing Execution System) provides out-of-the-box maximum standard functionality for all applications in the pharmaceutical and biopharmaceutical sector.
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 the MES software product in your manufacturing processes, you benefit from high quality and significant increase in efficiency.
Pas-X has multiple modules that make up the overall MES software. 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 processing step is fundamental to batch documentation. 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.
PAS-X Master Batch Records allows the user to easily set up and maintain libraries with standardized, reusable building blocks which can then be used to create an MBR (Master Batch Record). 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.
Efficient electronic batch documentation is one of the most important objectives in introducing an MES to pharmaceutical production. With PAS-X Electronic Batch Recording (EBR) 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 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.
Please contact PACIV today to discuss how we can support you in installing, integrating, improving and maximizing the value you receive from Werum Pas-X MES.