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 functionality:

Authentication at User Level

Calibration Control has the ability to individually authenticate each user for the purpose of audit trails and electronic signatures.

File Integrity

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.

Electronic Signatures

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).

Password Strength

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.

Locking Security

Ability to detect invalid user credentials, even locking compromised accounts, to prevent unauthorized access until the highest role (admin user) unlocks and resets that user record.