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Life Sciences

Shift traditional less-efficient, time consuming “start-stop-inspect” batch processes to On-Demand drug production

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MES Business Integration Goals

  • Follow industry best-practices, including standardized message schema for industry compliance
  • Improve real-time data capture between systems by utilizing event-based integration architecture
  • Reduce technical cost of ownership and improve adaptability by reducing custom components
  • Improve development efficiency by leveraging existing design/configuration whenever possible

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Key Outcomes of a Connected Plant

  • Electronic Batch Records
  • Parameterized Recipes
  • Review-By-Exception
  • Central Dispensing
  • Electronic Equipment logs
  • Additional Data Integrations
    • Material Tracking System
    • Laboratory Information Management Systems
    • Scales
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Validation Strategy

  • CSV Deliverables Embedded in project Methodology – NOT activity after software delivered
  • Collaborate and have agreements with CSQA
  • Just-in-Time formal approval of validation deliverables
  • Test scripts based on risk level
  • Utilize universal test cases where possible
  • Test standard objects once and verify correct implementation
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MES Implementation Strategy

Parallel Workstreams

  • Development of Master Recipes in Parallel
  • Workshops used to bring entire team together to confirm requirements, review design solution, finalize solution and perform final review
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Batch Production Record Generation

Minimize the replication of data.

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Data Contextualization

Use a preferred Third Party server interface software to visualize data.

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Equipment Integration

Achieve a single source of truth with production equipment and assets.

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Exception Handeling

Achieve a review-by-exception production methodology.

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MES/DCS Integration

Shorten the production introduction burden and technical transfer time.

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Order Scheduling

Release production orders as needed, as a function of predictive scheduling.

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Product Specific Data Management

Automatically transfer product specific data into recipes and sequence of functions.

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Real-time Production Scheduling

Proactively manage and simulate production schedules.

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