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Tips For Successful Remote FAT

Strong Leadership

  • Coordinates between key stakeholders
  • Drives on-time schedule completion
  • Expects the unexpected

Coordinate Communications

  • Ensure platforms are compatible
  • Strategize formal and informal communication during the process

Technology

  • Choose an intuitive video conferencing platform with break-out rooms
  • Employ chat capability for informal check-ins and quick questions

Design and Materials

  • Ensure design is finalized prior to FAT
  • Verify test materials are present at vendor site

What is FAT?

FAT is performed at a vendor facility prior to shipment of utility systems and manufacturing equipment to final installation site to verify the construction of the system meets the end user’s needs.

Tips for successful remote FAT

 

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.