The Best Electronic Data Capture Requirements Ideas. This allows any metric to be charted and reported on, spot trends. Most electronic data capture systems use audit trails and secure signatures to support 21 cfr part 11 validation and compliance requirements.
Take a look at a guide in building an electronic data capture system. Under 21 cfr 312.62, 511.1 (b) (7) (ii) and 812.140,. Clinical sites can access the edc system from any computer and enter data quickly and easily, making it immediately available to data reviewers.
