Smooth implementation thanks to PAS-X services

PAS-X Service Packages

We provide a comprehensive set of support and consulting services that complement our high-quality manufacturing IT solutions. The service portfolio is based on the best practices of the pharmaceutical and biotechnology industries. Due to the modular structure of our service portfolio, you will find a package that fits your needs.

With our services we support you during all PAS-X implementation phases: from Ready to Fit and Build to Run Phase. Thus, we take over many tasks which previously had to be accomplished by our customers and unburden their personnel during the MES implementation phase.

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Shawn Opatka

Phone: +1 973 646-3408

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Strategic Program ManagementSystem SupervisionChange ManagementService DeskGo-liveValidationTrainingDeploymentMBR DesignMigration conceptFit verficationBusiness Process DescriptionSystem ArchitectureBusiness Assessment

Business assessment

We conduct a business benefit analysis to identify the benefits a site can achieve by the introduction of a PAS-X MES system. This is the basis for a business case calculation that evaluates the economic efficiency.

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System architecture

We design a state-of-the-art IT solution for the introduction of the PAS-X MES. These services consider the existing customer IT landscape and ensure a smooth integration of PAS-X. Services related to system architecture cover IT blueprints, system integration and equipment integration:

IT blueprints

  • Conceptual functional distribution between IT systems based on ISA 95 compliant best practice functional distribution templates

System integration

  • Conceptual functional distribution between ERP, MES and other systems (e.g. LIMS, LES, CAPA, DMS) based on ISA 95 compliant best practice functional distribution templates

Equipment integration

  • Conceptual functional distribution between MES and equipment based on ISA 95 compliant best practice functional distribution templates
  • Technological integration concept for equipment integration

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Business process description

We offer business process consultation to create specific business process descriptions based on industry best practice business descriptions. Our customers benefit from the business process descriptions to enable process standardization, harmonization and optimization. We provide consultation to support our customers to gather requirements for the PAS-X MES system to be introduced.

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Fit verification

Together with our consultants you describe your current business processes. These processes are matched with PAS-X out of the box and the incorporated best practice industry templates. Besides configuration and parameterization of the PAS-X system, your business processes may be modified if necessary. The future business processes with PAS-X are described shaping the basis for the functional specification and customer-specific MBR templates.

A smooth fit verification is ensured by:

  • Key user training courses
  • Fit verification workshops
  • Integration workshops (ISA 95 level 4, 2 and 3)
  • Training concept
  • Validation concept
  • Infrastructure consulting

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Migration concept

We support our customers to setup a migration concept for the introduction of a PAS-X MES system. The migration concept describes in detail how a site shall migrate from paper to the PAS-X MES, or upgrading an existing MES to a PAS-X system.

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Deployment

The PAS-X customer template is built and configured in a test and qualification environment. It is qualified (FAT), delivered to the customer, installed and qualified (SAT) again. The parameterization of the PAS-X master data is done. Based on the MBR templates from the Fit Phase the final MBRs are created.

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Validation

The business processes in PAS-X already reflect and represent all the specifications and requirements laid out for regulatory compliance in the pharmaceutical and biotechnological industry. PAS-X as a pre-tested software product closely follows the interpretation of a risk-based approach as specified in GAMP 5 and thereby minimizes the validating efforts involved in a project.

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Go-live

We relieve our customers during cut-over and go-live of the PAS-X MES system and afterwards during the hyper care phase. Support is offered in any area of the project: IT support, trouble shooting, hands-on support for operators, etc.

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