Scope of this guidance 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 Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]