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Manufacturing Intelligence - Project Profiles

Integrated SCADA, Scheduling, Performance Information System

Design Group developed a complete integrated system for production order execution and tracking for a major US beverage company.  Using a client-server architecture, the system integrated with a number of different IT based systems for order dispatch, changeover management, performance management, and other key operational aspects.  Design Group provided system design, integration, simulation, and on-site commissioning of multiple production lines.

  • Redundant client-server architecture for high availability
  • Production order dispatch with all production run-to-order
  • Automation and detailed tracking of changeover procedures
  • Web based reporting and visualization of key manufacturing activities
  • Shop floor scoreboards showing current production and performance data


Enterprise CAPA System Integration and Validation

Design Group assisted in all phases of the system development life-cycle for an implementation of an enterprise level CAPA system across nine global client sites in three different languages. In addition to development and execution of all validation documentation, Design Group assisted in the technical installation and configuration and post go-live technical support plans. The scope of configuration and validation included the SAP and LIMS interfaces.

  • Compliance / ERES Assessment and Audit
  • Review System Requirements and Design Specifications
  • Develop and Execute Configuration IQ
  • Develop Traceability Matrix
  • Develop OQ Approach and Protocol
  • Develop and Execute Over 100 Test Scripts to Support Multiple Languages
  • Regression and Issues List Tracking and Coordination
  • Analyze, Author and Execute Scripts for LIMS and SAP Interfaces
  • Develop PQ Strategy and Protocol
  • Assist in Global Infrastructure Support Model


IT Quality System Audit and Remediation

Design Group was engaged to audit, perform gap analysis, develop and implement a remediation plan to improve the quality system of a publicly traded biotech company. Major remediation activities included the development of a Computer System Validation (CSV) core process, redeveloping the System Development Life Cycle (SDLC) and Change Management system. Each core process contained a policy, one or more procedures and templates. Guiding principles for gap analysis and remediation plans were based on:

  • FDA Quality System Inspection Technique (QSIT)
  • Design Group Quality System and Industry Leading Practices
  • ICH Guidelines
  • FDA 21 CFR Part 820
  • FDA 21 CFR Part 11
  • Project Management Institute Body of Knowledge (PMBOK)
  • Capability Maturity Model (CMM)

Additional Representative Projects

  • Laboratory Information Management System (LIMS) Validation
  • Maximo CMMS Validation
  • Quality Assurance Complaint Handling Database Validation

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