Simplified configuration of PAS-X MES

PAS-X Content Packages

Werum’s pre-configured PAS-X Content Packages allow a jump-start to deploying PAS-X MES. They are based on the best practice of the industry, the industry knowledge of the Werum consultants and reflect the requirements of the PAS-X user community. The content packages can be used to prepare PAS-X systems for different industries. Using PAS-X Content Packages, projects have an excellent starting point to create the final parameterization for a particular site.

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LIMS IntegrationEquipment Supplier SpecificEquipment IntegrationPackagingFit & Finish incl. SterileSolid DosageAPI ChemicalAPI BiotechWorkflowsRights & RolesReports & LablesMaster DataEquipmentQualityPerformance

Manufacturing intelligence

PAS-X as a batch recording system collects data from various sources into the batch record. The “PAS-X Performance" and "PAS-X Quality" Content Packages offer pre-configured evaluation templates for different areas such as performance data and quality data along with the associated comprehensive consulting services and a state of the art tool for data evaluation. 

The pre-configured evaluation templates comprise dashboards, production monitoring and process optimization to make this data available, easily accessible and convenient to visualize. This will enable visibility in manufacturing. Typical production questions such as trends for yield, exceptions, deviations and review times (time to market) are answered in a smooth way.

Available PAS-X Content Packages:

  • Performance
  • Quality

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Administration

The “PAS-X Equipment” Content Packages delivers a best practice guideline of how to design and document equipment status diagrams. It shows the dependencies and functionalities of the different states, activities and their respective semantics. Additionally, the package contains ready-to-use best practice status diagrams for e.g. cleaning, assembly, sterilization, reusables etc.

The “PAS-X Master Data” Content Packages detail relevant master data for PAS-X required to use the PAS-X system. The step-by-step parameterization guideline explains details regarding the master data and takes into account the sequence of creating master data and highlighting dependencies between them. Once all chapters of the content package were considered, a functional PAS-X system becomes available that can be used to create MBRs, execute orders and produce materials. 

Reports & Labels

The „PAS-X Reports & Labels“ Content Packages offer pre-configured reports (MBR reports, batch reports, etc.) and labels along with the associated comprehensive consulting services. These packages are based on best practices of the pharmaceutical and biotechnology industries. They comprise GMP-compliant templates for reports and labels which are specifically tailored to manufacturing technologies such as chemical and biopharmaceutical API production. Using the mature and reliable PAS-X Content Packages contributes to accelerating the PAS-X implementation. These content packages are not only reducing the initial effort to parameterize the MES system but also have an impact on the revalidation of the system.

The PAS-X Rights & Roles” Content Packages support the configuration of PAS-X user rights based on global, GMP-compliant profiles and specific roles such as Operator, Supervisor and QA/QM personnel. It considerably simplifies the configuration and maintenance of the highly flexible user rights capability of PAS-X. System administrators can save up to 95 % of the time usually required for the initial configuration and testing of rights. 

The “PAS-X Workflows” Content Packages deliver workflows for reviewing and releasing MBRs and EBRs including the evaluation of deviations. The packages are pre-configured based on industry best practices and can be adapted in a flexible fashion to customer needs. System administrators are enabled to manage PAS-X workflows in a self-dependent manner.

Available PAS-X Content Packages:

  • Equipment
  • Master data
  • Reports & labels
  • Rights & roles
  • Workflows

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Process libraries

The "PAS-X Process Libraries" Content Packages accelerate the development of MBRs and help to assure high quality MBR design based on the industry best practices. They support standardization of production processes, process harmonization across sites and the development of lean MBRs. MBR designers can save up to 80% of the time usually required for initial MBR creation. The packages provide templates with MBR design elements to create MBRs for specific pharma and biotech processes such as granulation, IPC testing or reconciliation. They are available for all major manufacturing technologies, such as API biotech, solid dosage and packaging.

Available PAS-X Content Packages:

  • API biotech
  • API chemical
  • Solid dosage
  • Fill & finish incl. sterile
  • Packaging

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Equipment libraries

The “PAS-X Equipment Integration” Content Package offers best practice guidelines of how to integrate equipment with PAS-X. Additionally, the package contains ready-to-use best practice state machines and MBR Design Elements for equipment integration. The “PAS-X Equipment Integration” libraries support standardization of equipment integration. MBR designers can save up to 80% of the time usually required for initial MBR creation considering equipment integration.

The “PAS-X Equipment Supplier Specific” Content Packages accelerate the creation of MBRs and help to assure high quality MBR design based on the industry best practices. They contain templates with MBR design elements to create MBRs for the integration of specific pharma and biotech equipment such as granulators, tablet presses or packaging lines.

The “PAS-X LIMS Integration” Content Package provides several best practice MBR workflows for the integration of data exchanged between LIMS or similar systems and PAS-X EBR. These workflows are provided as library templates which use preconfigured, ready-to-use message schemes as basis for the data exchange. The Content Package is complemented by a comprehensive documentation package.

Available PAS-X Content Packages:

  • Equipment Integration
  • Equipment Supplier Specific
  • LIMS Integration

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PAS-X Evaluations

The web portal for monitoring and analyzing manufacturing data

The PAS-X Evaluations Content Package helps to unlock the full potential of shop floor data. Use your data to continously improve manufacturing processes and to meet regulatory compliance requirements. PAS-X Evaluations enables you to generate knowledge about manufacturing operations at any time. Shop floor personnel are able to identify opportunities for improvement and to report evidence of improvements. You can either add the evaluation tool as a module to your PAS-X installation or install it as an entry-level solution together with PAS-X KPI/OEE.

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