White Paper

Considerations For Using eTools In Research: Part 11 And System Validation

Source: Quorum Review IRB

By Mitchell Parrish, JD, RAC, CIP, VP of Legal Affairs and James Riddle, MCSE, CIP, CPIA, VP of Client Services

Considerations For Using eTools In Research: Part 11 And System Validation

Technology is advancing all around us. Traditional paper-based processes are rapidly being replaced with a proliferation of electronic tools to capture and automate clinical research activity. Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead including:

  • U.S. and international regulations
  • Part 11 and Annex 11: two parts, records and signatures
  • Validating your system
  • Division of responsibility