According to FDA’s 2007 Guidance for Industry Computerized Systems Used in Clinical Investigations:
If you are conducting a clinical trial and using computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial.
• Applies to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.
• Applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyzer or a Holter monitor to a laboratory information system).
• Applies to when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading).
