MS Access is a common database platform to store data such as process, laboratory, calibration, equipment, instrument, inventory, product complaints, or training records.
Selected 21 CFR Part 11 Issues for MS Access Applications
Lack
of Audit Trails
Lack
of Electronic
Signatures
Password
Management may not
be compliant with 21
CFR 11.
Password
Aging may not be
compliant with 21
CFR Part 11.
The eInfotree Plug-In Solution
The eInfotree Plug-In solution provides 21 CFR Part 11 compliance for MS Access databases, with:
Security:
Access to the database is only available to authorized personnel. Users must login to have access rights to the database. Users can be imported from existing workgroup files.
Audit Trail: All changes made to the database are logged in an audit trail.
Electronic Signatures: Electronic signatures can be enabled or disabled based on system configuration.
Password Management: Fully compliant with Password Management requirements of 21 CFR Part 11.
Password Aging: Fully compliant with Password Aging requirements of 21 CFR Part 11.
Session Timeouts: User sessions will automatically time-out after a configurable period of inactivity.
