Qualification
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At TRAQuE we often say our bread and butter is qualification.

Whether you are looking to start up a new facility, make additions to an existing system, or bring your processes up to date with the latest industry and regulatory standards and trends, our consultants can help.

With extensive experience in the design, construction, qualification and start up or numerous facilities, our consultants can provide the right level of expertise and support to help your team deliver your project on time and on budget.

We have extensive experience in delivering projects in line with ISPE Baseline, GAMP 4 & 5, ASTM 2500, as well as a multitude of multinational corporate standards and policies.

We can help provide turn key solutions to fully integrated teams working alongside your own staff. Working from the start of the project on a blank sheet of paper, through to helping sort the mountain of documentation at the end of a project, TRAQuE can support in each and all of the following aspects of the validation lifecycle:

  • Validation Master Planning and Risk Assessment for Validation
  • User Requirement, Functional, and Design Specification Development
  • Design Qualification & GMP Reviews
  • Commissioning and Plant and Equipment start-up
  • IQ / OQ / PQ Protocol preparation
  • IQ / OQ / PQ Protocol Execution
  • IQ / OQ / PQ Report preparation
  • Deviation Investigation and Resolution
  • Risk Assessment and Management
  • Change Management
  • Cycle Development
  • Cleaning Validation
  • Process Validation
  • Media Fill Validation
  • Integrated C&Q
  • Thermal Mapping
  • Turnover pack preparation
  • Document Management and Control
  • Environmental Monitoring
  • Steam Quality Testing
  • Calibration
  • Requalification

Our expertise encompasses all areas of qualification, including:

  • Facility & Utility Qualification
  • Warehouse & Shipping Validation
  • Manufacturing & Packaging Equipment Qualification
  • Laboratory Equipment Qualification
  • Process Equipment Qualification
  • Analytical Method Validation
  • Computer Systems Validation


If you would like more information, please contact us to "Get On TRAQuE"

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Please contact us if you would like further information on any of our products or services. We will get back to you as soon as possible.

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