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User Administration

Role-based access, electronic signature and an audit trail that holds up

Part 11 compliance is decided here. Who can do what, whose signature means what, and whether the record of both can be altered afterwards. DeepPharmaERP keeps an append-only audit trail with reason for change, separate from the transactional data and outside the reach of a system administrator.

Audit trail
09:14:22BMR-FP2411-087 · step 03 · SIGNED — A. Rao (Production)
09:16:41BMR-FP2411-087 · step 03 · VERIFIED — S. Nair (QA)
11:02:07SPEC-PAR-500 · limit changed 98.0→98.5 · reason: revised MOA
16:41:55BATCH FP2411-087 · RELEASED — 2 signatures
17:03:12USER jdoe · role change denied · segregation of duties
Capabilities

What User Administration covers

Access

  • Role-based access at module, task and operation level
  • User and role rights matrix with segregation of duties checks
  • Electronic signature bound to the user, the record version and the intent
  • Session control, password policy and account lockout

Trail and alerts

  • Date and time stamp on every user action, taken from the server
  • Append-only audit trail with reason for change, not deletable by any role
  • User-wise, transaction-wise and task-wise audit trail review
  • Alerts and notifications matrix by event and by user

Operations

  • Database backup and restore with verification
  • Backdated transaction control and period locking
  • Login history and report generation logging
This is the module that decides whether the rest of the system is defensible. We treat it as foundational rather than administrative.
AI in this module

What the system notices for you

Suggestions only. Nothing here signs, approves or dispositions anything — a qualified person decides and the audit trail records who. Every model shows the data behind its suggestion, and every feature can be switched off per site.

DeepPharma AI

Access anomaly detection

Notices when a user starts behaving unlike their role and unlike themselves.

DeepPharma AI

Segregation of duties analysis

Finds role combinations that let one person complete a controlled process alone.

DeepPharma AI

Audit trail review assistance

Surfaces the entries in a review period that are worth a human reading.

How the AI works across the plant
Questions

User Administration — common questions

Can a system administrator alter the audit trail?

No. It is written to a separate append-only store with delete permission removed at the database role level, and timestamps come from the server rather than the workstation. This is deliberate and it is the foundation the rest of the compliance claim rests on.

How are electronic signatures different from a login?

A signature requires re-authentication at the moment of signing, records a stated meaning — performed by, verified by, approved by — and binds to the exact version of the record signed. A login only proves who opened the session.

See it on your own floor.

Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.