Regulations FDA

MOVEit is fully compliant with Food and Drug Administration (FDA) standards for timestamps as related to the auditing of medical information which may be transmitted via or placed at rest on MOVEit DMZ.

MOVEit DMZ's complete compliance statement follows.

Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures

(Maintained online here: http://www.fda.gov/ora/compliance_ref/part11/ )

Timestamp Draft Sections 5.1-5.2

N/A (MOVEit DMZ is not responsible for administrator/auditor training or the operating-system level synchronization of machine clocks.)

Timestamp Draft Section 5.3

"You should implement time stamps with a clear understanding of what time zone reference you use. Systems documentation should explain time zone references as well as zone acronyms or other naming conventions. For example, the time zone reference might be a central point like Greenwich Mean Time, a point local to the computer where the activity linked to the time stamp occurs, or a point where the time stamp clock (e.g., a time stamp server) is located."

If enabled, MOVEit DMZ displays the difference between the server's time and Greenwich Mean Time (commonly expressed as GMT +/- HH:MM). This field is visible on the LOWER LEFT side of the screen in the web interface and as a "welcome banner" when signing onto the web server.

Timestamp Draft Section 5.4

"You should take steps to ensure that date and time expressions are clearly understood throughout an organization."

MOVEit DMZ uses AM/PM to designate times and uses a date format of "MM/DD/YYYY"

Timestamp Draft Section 5.5

"Audit trail and signature time stamps should be precise to the hour and minute."