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