Preparing For Remote Agency Inspections

Types of Remote Agency Inspections

  • Desktop: Document exchange, email
  • Distant: Document exchange, teleconference
  • Virtual: Mixed reality, 360 degree video streaming

Additional Considerations for Remote Inspections

  • Designate a specific point of contact
  • Maintain professionalism in communications
  • Check file formats and sizes
  • Test new technology in advance
  • Use secure content exchange platforms
  • Dedicate support with technology familiarity
  • Handle multiple time zones
  • Anticipate a learning curve on technology
  • Strong and available internet access

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.