919-827-0933

TrackWise Modifications for Change Management

TrackWise Change Management Workflow Qualification

Duration- 4 months

Overview:

Commission and Qualify the new Change Management group of workflows in TrackWise. The new Change Management project included 5 workflows (3 new and 2 modifications of existing workflows). The Change Management workflows will be utilized at the three sites and qualified for use at each division and additionally as a global division for managing changes shared across sites.

 Scope of Work:

The project scope included:

  • Risk Assessment Development and Approval
  • Functional Testing (Development and Quality Systems)
  • Protocol Development and Execution
  • Training Development
  • SOP Review and Support

The Mangan team collaborated with the IT and Quality department to qualify the Change Management workflows within TrackWise, in addition, helped support use of the system through Training development and SOP reviews.

Outcome:

The Change Management workflows were qualified for GMP use and implemented successfully globally.

 

Control System Upgrade: Lyophilizers

Control System Upgrade for Production Lyophilizers

Duration- 6 months

Overview:

Upgrade the existing control system for production lyophilizers at a large biotech company.

Scope of Work:

The project scope included:

  • PLC and HMI Upgrade for Multiple Lyophilizers
  • ControlLogix and iFIX
  • Programming
  • Design Documents (DDS, SRS, FRS)
  • Functional Testing
  • Protocol Development and Execution
  •  FTBatch HMI/SCADA

The Mangan team collaborated with the onsite automation staff and business users to perform design reviews to optimize HMI displays and screen navigation.

Outcome:

Project was completed successfully on time.