PAS-X Content Suite

The Werum PAS-X Content Suite is a software solution from Körber Pharma designed to accelerate the deployment of the Werum PAS-X Manufacturing Execution System (MES). It is aimed at pharmaceutical, biotech, and cell & gene therapy manufacturers who want to configure and implement their PAS-X MES quickly, efficiently, and with reduced risk. The Content Suite provides pre-configured, industry best-practice content packages that support users in setting up their individual MES environments in collaboration with Körber consultants.

In total, the PAS-X Content Suite offers 16 content packages across four core areas: Administration Templates, Process Libraries, Integration Libraries, and Equipment Libraries. These packages enable organisations to implement their own business processes rapidly while ensuring data integrity, lean batch records, and process harmonisation.

Administration Templates

• Equipment State Diagrams – Supports the design and documentation of equipment status diagrams, including ready-to-use best-practice status diagrams for processes such as cleaning, assembly, and sterilisation.
• Master Data: the right way – Provides detailed guidance on master data for PAS-X MES deployment, explaining individual data elements and the correct sequence for creating master data records.
• Reports & Labels and Enhanced Label – Includes GMP-compliant templates for reports and labels, as well as pre-configured reports such as manufacturing records and batch records.
• Rights & Roles – Supports the configuration of PAS-X MES user rights based on global, GMP-compliant profiles and specific roles such as operator, supervisor, or QA/QM staff.
• Workflows – Provides best-practice information for adapting release workflows, including Master Batch Records (MBRs) and Batch Record Reviews (BRRs), relevant for PAS-X MES version 3.1.8.

Process Libraries

Process Libraries are designed to accelerate the development of MBRs and help ensure high-quality MBR design based on industry best practices, with a focus on data integrity, lean BRRs, and process harmonisation. They are available for key manufacturing technologies, including:

• API Chemical/Biotech
• Solid Dosage
• Fill & Finish incl. Sterile
• Packaging
• Cell & Gene

Integration Libraries

• Equipment Integration – Contains best-practice guidelines for equipment integration into PAS-X MES, including ready-to-use best-practice state machines and MBR design elements.
• LIMS Integration – Provides multiple best-practice MBR workflows for integrating data exchanged between LIMS or similar systems and Werum PAS-X MES (relevant for PAS-X MES version 3.1.8).
• MSI Integration – Delivers detailed information on generating message descriptions based on pre-configured templates, as well as configuration and use of the MSI simulation tool.

Equipment Libraries

• Equipment Supplier Specific – Provides MBR design elements for creating MBRs that integrate specific pharmaceutical and biotech equipment such as granulators, tablet presses, and packaging lines.

Key Benefits

• Easy start – Enables simple, fast, and reliable setup of the Werum PAS-X MES environment.
• Time savings and risk reduction – Allows organisations to implement their own business processes quickly, minimising project risk.
• Secure and efficient – All content is based on established industry best practices, supporting GMP compliance and data integrity throughout the implementation.

The PAS-X Content Suite is part of Körber's broader PAS-X ecosystem, which also includes the Werum PAS-X MES Suite for real-time process control and documentation, and the PAS-X Savvy Suite for bioprocess data management and analytics. Together, these solutions support pharmaceutical and biotech manufacturers in building a comprehensive, digitally integrated manufacturing environment.