Scope Computerized systems that contain data that support a marketing application Case histories Analytical test results (e.g., LIMS) Data captured from analytical instruments Electronic transcription of hardcopy source data it Does not apply to Computerized medical devices* Study Protocols •Identify computerized system use within the trial process •Computerized systems must: –Satisfy process requirements defined in Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]