eCADinfo Engineering Data Management System 21 CFR Part 11 Compliance

User Audit Trail: Stores all user actions such as drawing changes, check in, check out, view, add, delete, edit discussions, and edit notes.

Drawing Audit Trail: Stores standard block, attributes, layers and block changes to drawings. Compare any two drawing versions graphically.

Database Records Audit Trail: Stores all record versions and highlights changes between any two record versions since creation.

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

Audit Trail Display: View the audit trail at any hierarchical level with a single click. Group the audit trail by action, user, date or any other field. Query the audit trail using arithmetical or logical operators.

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

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

Configurable E-Signature Assignment: Different templates can be applied to different engineering data/drawing object types (eg. GMP vs. non-GMP) 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: Engineering data is stored securely in the system database. Drawing and other files are stored in the secure File Vault with Version Control, Configurable Version Numbering and Check In/Check Out features.

Security Templates: Create security templates defining access levels for engineering data operations. Control user privileges such as Add, View, Edit, Checkin, Checkout, Delete and None (no access).

Configurable Security Template Assignment: Different security templates can be applied to different engineering data/drawing 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.