GxP Compliance Command Center

Audit trail visibility, electronic signatures, and validation assets for 21 CFR Part 11 readiness.

Demo Mode

Audit trail feed

Immutable event log with justification, user attribution, and record deltas.

3 approved changes

1 pending review

Audit schema active

Timestamp	User	Table	Action	Reason	Status
2026-01-24 09:12	demo@biopharma.dev	batches	UPDATE	Yield reconciliation after assay Actual yield updated from 2.1 kg to 2.3 kg	Approved
2026-01-24 08:41	admin@biopharma.dev	inventory_lots	INSERT	Lot release from QC Lot DP-1045 released to clinical depot	Approved
2026-01-23 18:05	demo@biopharma.dev	projects	UPDATE	Clinical timeline alignment Phase II milestone moved by 4 weeks	Pending
2026-01-23 16:22	reviewer@biopharma.dev	experiments	INSERT	New DoE study created DoE-2026-07 for resin optimization	Approved

Signature queue

Electronic signature workflow with re-authentication controls.

Batch BR-2104

Pending

Approve batch record

Owner: Quality • Due: 2026-01-25

Deviation DV-118

In Review

Review deviation

Owner: QA • Due: 2026-01-26

Experiment DOE-318

Approved

Approve protocol

Owner: Process Development • Due: 2026-01-22

Validation status

CSV assets tied directly to the platform release cycle.

URS-001: Digital CMC Cockpit

Owner: Validation • Updated: 2026-01-20

Approved

OQ-014: Audit Trail Verification

Owner: QA • Updated: 2026-01-24

In Review

Traceability Matrix v3.2

Owner: Validation • Updated: 2026-01-18

Approved

Compliance-ready data foundation

Every change is attributable, reviewable, and exportable for regulatory submissions.

This demo reflects the architecture used in the private workspace: database-level audit triggers, e-signature gating, and validation documentation tied to each release. Extend with SOPs, retention policies, and automated change justification workflows.

Engage for compliance readiness