Food and Drug Administration Expects Ready Instant Messaging Access

The Food and Drug Administration expects information systems to be developed with easy access to electronic records and evidence (instant messaging as well as e-mail). FDA regulation 21 CFR Part 11 specifies that records can be audited by the agency, and according to Section 11.10 (e), audit records for computer systems also ‘‘shall be available for agency review and copying.’’ ^[4]

^[4]Nancy Flynn and Randolph Kahn, Esq., E-Mail Rules, New York, AMACOM, 2003.