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