FDA 21 CFR Part 11 Compliance
FDA Software Compliance
Ape Software's calibration management software (Calibration Control) complies with
FDA 21 CFR Part 11 Rule on electronic records and signatures by containing the following
Authentication at User Level
Calibration Control has the ability to individually authenticate each user for the
purpose of audit trails and electronic signatures.
The default MS Access back-end database is secured through password encryption,
which includes tamper detection. If an MS SQL Server is used as the back-end
database, instead of MS Access, the necessary security features are already part
of SQL Server.
Change Management (Audit Trails)
All user activities (e.g., record changes & calibrations) are automatically recorded
in the Change Log to provide an audit trail.
Re-entry of password required upon electronically signing (approving) Calibration
Event (optional). Also, inherent in the Change Log, all user activity relating
to equipment maintenance and calibration is recorded (electronically signed).
Ability to define the strength required for passwords including numbers of upper,
lower, number, and special characters. Ability to define expiration intervals
and other features.
Ability to define the number of inactivity minutes in a usage session before the
application times out and users are required to sign in again.
Download Calibration Control