eSTAR - Electronic Stability Testing Analyses & Reporting

21 CFR Part 11 Compliance:

EAPHARMICS software packages fully conform to the criteria
put forward in 21 CFR Part 11 for "closed systems" .

File encryption
System access is controlled by the system supervisor
Limit system access
Limit module access
Password expiration
Bilateral user ID and password identification
Access failure lock out
System access logs
System audit trail
System edit logs
21 CFR Part 11 compliant