White Paper

Considerations for Using eTools in Research: Part 11 & 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.

Topics

  • US and international regulations
  • Part 11 and Annex 11: two parts, records, and signatures
  • Validating your system
  • Division of responsibility
Download our free white paper Considerations for Using eTools in Research: Part 11 & System Validation.





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