Recipient: Rosenthal Eye and Facial Plastic Surgery.
Product: Investigational devices
Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr. Steyert that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you to Mr. Steyert, dated January 31, 2005, detailed the name of the EMR system and the means by which study subject information is entered. Please note that Title 21, Code of Federal Regulations, Part 11, “Electronic Records; Electronic Signatures” outlines specific requirements that must be met for any system that is being used to maintain required records. In addition to the information requested above, please submit the following:
documentation of a secure, computer-generated, time-stamped audit trail that can independently record the date and time of operator entries and actions that create, modify, or delete electronic records, and to verify that record changes do not obscure previously recorded information.
Issuer: Center for Devices and Radiological Health (CDRH)