Common 21 CFR Part 11 Issues for Database Applications
Lack
of Audit Trails
Lack
of Electronic
Signatures
Inadequate
Security
Password
Management. Passwords
may not comply with 21
CFR Part 11
requirements for
password management.
Password
Aging. Passwords may
not comply with 21 CFR
Part 11 requirements
for password aging.
Database
platform may not be
ideal for large scale
applications, for
large number of users,
or as a file or
document management
system.
The eInfotree Solution
Migrate data easily from your legacy system to the Oracle-based eInfotree platform using automated data migration tools. eInfotree is fully compliant with 21 CFR Part 11, with:
Basic audit trail
Comprehensive audit trail
Electronic Signatures
Data available using a client/server and web-based browser interface
Use of a more robust and reliable database platform
