eChangeinfo Change Management System 21 CFR Part 11 Compliance

Audit Trail: Stores all user actions in an audit trail with timestamp, user name, user ID, action performed, old value, new value and reason fields as applicable.

Administrator Audit Trail: Stores all administrator actions such as e-signature configurations, reason field assignments, user management, and user privileges.

Configurable Reason Fields: Set to optional or required based on object/action combination.

E-Signature Templates: Create e-signature templates defining the operations that require e-signatures.

Configurable E-Signature Assignment: Different templates can be applied to different object types for unlimited flexibility and control.

E-Signature Roles: Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.

Protection of Data: Data is stored securely in the system database.

Security Templates: Create security templates defining access levels for all operations. Control user privileges such as Add, Edit and Delete.

Configurable Security Template Assignment: Different security templates can be applied to different object types for each user group for unprecedented flexibility and control. 

Password Aging: Force a new password after a configurable amount of time.

Password Lockouts: Lockout the application after a configurable number of retries.

Session Timeouts: Lockout the application after a configurable session time-out period.

Password Masking: Force passwords to match a password mask.