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Replacement of a Recipe Management and Reporting System

Cutting-edge system for recipe management, batch execution, and batch management keeps company viable. 
  • A new recipe management and reporting system maintains federal compliance-Gannett Fleming

    The recipe reporting system interfaces with equipment on a sterile filling line.

Client
Confidential Client

Location
Johnston County, North Carolina

Our Role
SCADA System Design, Implementation, Commissioning.

Data
Construction Cost
$500,000
Completed
2006
Duration
3 years
Outcomes
  • Technologically sustainable recipe and reporting system for GMP operations
  • System is CFR Part 11 compliant and aligned with ISA88.

To ensure continued production operations and minimize compliance risks and data loss, a sterile filling facility needed a technologically sustainable solution to replace a custom-coded out-of-date single Oracle server.

The implemented recipe and reporting management system (RRS) is a comprehensive solution for the management and control of production operations. The RRS stores, archives, and manages, with edit and download functions, the production recipes, which dictate the production operations configuration and parameters. The RRS also stores, archives, and generates reports for the resulting batch data. The system reduces the possibility of mistakes and provides operators with the flexibility to transfer lines or change equipment, which can increase efficiency and quality.   

What We Did

Gannett Fleming provided system design, development, and testing, then performed installation, start-up, and commissioning activities. The firm also provided system training and documentation. 

Gannett Fleming implemented a cutting-edge RRS that is both expandable and technologically sustainable. Two virtualized, redundant servers with configurable, commercial off-the-shelf software offer recipe management, batch execution, and batch management that is 21 CFR Part 11 compliant and aligns with ISA 88. The RRS was implemented via the integration of GE Proficy iFIX, GE Proficy Batch Execution, Informetrics InfoBatch, and Marathon Technologies' everRun FT software. Batch control objects were added to the iFIX SCADA system to manage the recipe functions and provide a user-configurable recipe system, consisting of more than 50 unit operations across five production lines.   

Key Features

  • Informetrics InfoBatch software was integrated with the existing GE Proficy iFIX SCADA process control system for reporting functionality for product release documentation.
  • InfoBatch generates reports by querying various databases, which are configurable for each report, to display and print the relevant data
  • The GE Proficy Batch Execution software was integrated with the existing GE Proficy iFIX SCADA process control system
  • Marathon Technologies' everRun FT software virtualizes hardware redundancy and provides fail-over protection.

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