ABSTRACT
The Food and Drug Administration (FDA) is very concerned, and rightly so, about the quality and integrity of data associated with clinical trials. In 21 CFR 11, and in guidance documents, the agency repeats the term, “authenticity, integrity, and confidentiality of electronic records” frequently to get the point across. The regulation is clear; §11.10 requires controls and procedures including: “(d) Limiting system access to authorized individuals,” and “(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.”
