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Equipment Qualification and Validation Services

  • Master Plan development & implementation

    • verification, commissioning, validation, project planning, risk management

  • Development, training and implementation of Good Engineering Practices to support the commissioning effort

  • User Requirement  Specifications development (URS)

  • Support Change Control Protocols and Systems

  • Factory Acceptance Testing development and execution (FATs) 

  • Site Acceptance Testing development and execution (SATs)

  • Formal release or turnover activities 

  • Develop System Acceptance criteria

  • Periodic Review development of the qualified systems

  • Commissioning and Qualification, Verification, Validation, or other testing activities

Types of Equipment, Facilities and Systems

Processing Equipment

Liquid, powder, components / particulates and bulk

Packaging Equipment

Filling primary packaging in all forms to palletizing, robotics, conveyance and everything in between

Quality Controls

Vision and inspection systems, various types of coding and labeling applications, x-ray and metal detection, check weighing scales, and sorting

Support Equipment & Facilities

HVAC, Clean in Place (CIP), Clean out of Place (COP) systems, heat exchangers and chillers

Warehouse, climate controlled & ammonia / nitrogen freezers, hot rooms