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Overview

Werum PAS-X MES Suite is a leading MES for pharmaceutical and biotech manufacturing, delivering error-proof production and 98% right-first-time efficiency. While deployment can be lengthy and resource-intensive, its robust, compliant features ensure reliable, high-quality operations across complex, large-scale production environments.

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PAS-X Specifications

Production Planning

Inventory Management

Quality Control

Supply Chain Management

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What Is PAS-X?

Unlike generic Manufacturing Execution Systems (MES), the Werum PAS-X MES Suite by Körber Pharma is purpose-built as a world-leading MES for the highly regulated pharmaceutical, biotech, and cell and gene therapy industries. It digitally transforms production by replacing time-consuming, error-prone paper-based Master Batch Records (MBRs) with Electronic Batch Records (EBRs), establishing a benchmark for real-time control and compliance across the entire manufacturing cycle. PAS-X is a scalable, GMP-compliant solution available for both on-premises and cloud deployment (PAS-X as a Service).

PAS-X Pricing

PAS-X pricing is customized and based on user needs and requirements. Request a personalized PAS-X price quote for your business today!

PAS-X Integrations

Werum PAS-X MES Suite is designed for seamless vertical and horizontal integration across the manufacturing IT stack. It connects to surrounding IT systems via clearly defined standard interfaces that comply with international industrial standards. It integrates with:

  • Amazon Web Services (AWS)
  • Microsoft’s Azure
Request a free PAS-X demo to learn more about its integration arrangements.

Who Is PAS-X For?

Werum PAS-X MES Suite is utilized by organizations across various industries and sectors, including:

  • Pharmaceutical manufacturing
  • Biotechnology and biopharma
  • Cell and gene therapy
  • Contract manufacturing organizations
  • Quality assurance (QA) and quality control (QC) departments
  • Manufacturing IT and automation specialists

Is PAS-X Right For You?

Werum PAS-X MES Suite is uniquely suited for companies that prioritize uncompromising regulatory compliance over lower upfront costs. Its specialized design ensures a higher level of compliance than general MES platforms. Additionally, the availability of PAS-X as a Service, offered in partnership with AWS and Azure, delivers superior cloud reliability and scalability—simplifying IT management and enabling a future-proof Pharma 4.0 ecosystem compared to traditional on-premises systems.

Still not sure about PAS-X? Contact our support team at (661) 384-7070 for further guidance.

PAS-X Features

Replacing paper methods, this feature digitizes complex MBRs to ensure reliable execution and compliant documentation. It drastically shortens approval cycles and ensures a high 'right-first-time' production rate compared to manual validation.

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Unlike generic asset tracking, this module provides comprehensive administration and monitoring of equipment status, including cleaning procedures. It covers all equipment-related requirements in pharma and biotech to ensure compliance and minimize production disruption.

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PAS-X features basic control systems by ensuring precise, error-proof material handling through digital control, making processes significantly more efficient and fail-safe than manual or semi-automated weighing. It controls the digital weighing and dispensing of input materials according to recipes.

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Unlike basic sequencing tools, the PAS-X Operations Scheduler synchronizes complex operations with supporting activities, integrating planned tasks with real-time production status. This approach generates highly optimized schedules that significantly reduce lead times and production costs compared to conventional scheduling methods.

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Going beyond standard inventory tracking, this is a specialized serialization solution designed to actively combat counterfeit drugs and ensure full global regulatory compliance. It provides superior traceability over basic MES systems by tracking the path and identity of medical products throughout the supply chain.

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Pros And Cons of PAS-X

Pros

  • Robust regulatory compliance with FDA 21 CFR Part 11 and EU GMP Annex 11

  • Modular and scalable architecture suitable for multi-site global rollouts

  • Pre-configured industry content reduces implementation and validation effort

Cons

  • Managing complex capabilities may require a stronger skillset

  • Security updates/updates may slow down implementation time

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Frequently Asked Questions

PAS‑X MES Suite is used by organizations across sectors such as pharmaceutical manufacturing, biotechnology and biopharma, cell and gene therapy, and contract manufacturing organizations (CMOs).

Werum PAS-X MES Suite offers comprehensive, global support, including consulting services for implementation and validation, remote assistance (Körber Xpert View), and ongoing system maintenance and upgrades.

The Werum PAS-X MES Suite primarily supports English, Dutch, Japanese, and Chinese.

PAS-X does not have a dedicated mobile app.

PAS-X software does not offer an API.

PAS‑X MES Suite supports seamless vertical and horizontal integration across the manufacturing IT stack and connects to surrounding IT systems via standard interfaces. For example, it integrates with Microsoft Azure and Amazon Web Services (AWS).

PAS‑X MES Suite pricing is customized and based on the specific needs and requirements of each user. You can request a personalized PAS-X cost quote for your business.

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