Compliance

Designed to support regulated electronic records and signatures

UNENTROPY-eDMS provides the technical controls regulated teams are asked for: audit trails, electronic signatures, access control, and data integrity. These are the building blocks of Part 11 and GxP-style document workflows.

A note on scope

UNENTROPY-eDMS is not presented here as "Part 11 certified". No software product can be certified on its own. What we provide are the technical controls (audit trails, e-signatures, access control, data integrity) that Part 11 / GxP workflows commonly require. Validation of your specific process, and procedural compliance, remain the responsibility of your organization and your quality function.

Audit Trail Depth

Six categories of activity, logged automatically

Nothing needs to be turned on. Every session, document action, and permission change is captured by default.

Login Audit User Activity Audit Password Audit Permission Audit Printing Audit Document Audit

Audit data supports compliance reporting and forensic analysis, with real-time filtering when you need to answer "who did what, and when."

/compliance/audit-trail
08:02Login
08:14Document
08:40Permissions
09:02Password
09:33Printing

Electronic Signatures

Signature capture bound to the record

  • Signature capture at approval-gated workflow steps
  • Signature meaning (e.g., "reviewed," "approved") recorded alongside the signing event
  • Signatures tied to the specific document version being signed
  • Signing identity re-verified at the point of signature
/documents/sign
Signed · "Approved for release" · v3.2

Access Control

Permissions scoped to role, group, and hierarchy

Access is granted through roles rather than to individuals, so an access review reads as a handful of rows instead of one line per employee.

Representative role model. Roles, permissions, and hierarchy are configured per deployment.
Capability Author Reviewer Approver QA Admin
Create and edit drafts Yes Yes
Comment and annotate in review Yes Yes Yes Yes
Advance stage / sign as reviewer Yes Yes
Final approval and publish Yes
Supersede or archive a published document Yes Yes
Assign roles and permissions Yes
Read the full audit trail Own actions Yes

Granular, not coarse

Permissions cover routes, individual actions, and data operations rather than a handful of broad tiers.

Inherited, not copied

Permission sets inherit through the group hierarchy, so a change applies everywhere instead of drifting per user.

Monitored

Activity analytics surface access patterns that fall outside a role's normal behaviour.

Data Integrity & Versioning

One version of the truth, at every stage

  • Full version history with no silent overwrites
  • Approval gates before a document can advance stage
  • Controlled publishing and archival, not ad hoc file deletion
  • Document status always reflects the latest approved state
/documents/versions
VersionStatusSignedDate

See UNENTROPY-eDMS on your documents

A working session with your team, using your document types and your approval steps rather than a canned demo file.