Human Subjects Research

FDA Part 11 Certification

Washington University School of Medicine has submitted our certification letter to the FDA indicating that the Washington University owned clinical applications are FDA Part 11 Compliant. Please note that this certification does not cover any of the systems owned by BJC or its entities (for example, ClinDesk), which will need to be certified separately by BJC.

We can now respond to sponsors that Washington University owned clinical systems are FDA Part 11 Compliant. We have documentation of the review for Allscripts, Cederon Connect, MARS, WUMED and the Pediatric database specifically. Any other or new Washington University owned systems should be reviewed for FDA Part 11 compliance. Please do not make this assertion about any hospital owned applications such as ClinDesk.

If you have a question about a particular system and whether it meets FDA Part 11 requirements, please contact the Medical School Central IT Services helpdesk at 314-362-7798.

RNews Certification Announcement (PDF)

WUSM Letter for Certification (PDF)