What Each Actor Sees | qmsWrapper Technical Overview

7. What Each Actor Sees

Actor	What Wrapper shows them	When
Employee (anyone)	Notification bell + Todo list; quality-event reporter; AI Chat scoped to current page.	Continuously.
Trainee	Training assignments in /todo ; PIN-sign-on-acknowledge for SOP changes.	On assignment + recertification.
PRRC	MTF + EUDAMED + Vigilance dashboards; PRRC appointment letter; per-device Regulatory Health Score; AI Findings inbox.	Daily.
RA Lead	MTF + SaMD-TF + EUDAMED + Vigilance + Submission Package Generator + NB Communication Log + AI Governance Log.	Daily during submission cycles.
QMS Manager	Management & Audit dashboard; ISO 13485 clause-coverage map; AI Findings inbox; CAPA queue; Approval queue; Audit-Readiness gauges; SOC-2 Evidence Locker.	Daily.
QA Contact	QES triage; CAPA stage advancement; Receiving-QC alerts; Vigilance incident classification.	Daily.
Engineer / Designer	TF / SaMD-TF tabs; Traceability Matrix; Risk Log; Training assignments.	Daily during development.
AI/ML Lead	AI Governance Log — every system, dataset, model version, V&V run, monitoring tile.	Daily.
Information Security Officer	Cybersecurity Log — ISMS Doc Register, Vuln Tracker, SBOM Registry, Pentest Results, Access Control Review, SOC-2 Evidence Locker, FDA Cyber Submission Package.	Daily.
Purchasing Agent	Supplier Master Registry; Receiving QC; Switching & Dual-Sourcing scorecards.	Daily.
Internal Auditor	Management & Audit Log + per-clause evidence drill-down; CAPA audit; Training audit; Cyber audit.	Quarterly internal-audit cycle.
Executive	Regulatory Health Score gauges per device per regulator; Open Gaps by Regulation; Vigilance Snapshot last-30d; NB Communication queue.	Weekly.
NB Auditor	Every Log filtered by audit scope; the same dashboards the QMS Manager uses; AuditSignature chain.	Annual surveillance + unannounced.
FDA Inspector	CAPA Log + Complaint Files + Design-Controls evidence + QMSR clause coverage + Cybersecurity evidence + AI Governance Log + AI HITL audit.	FDA inspection.
MDSAP Auditor	ISO 13485 clause map + per-chapter evidence + Training + CAPA + Supplier + Risk.	MDSAP audit.
EU Competent Authority	Vigilance Log + EUDAMED submission status + UDI Registry + DoC store.	On request + per vigilance reporting.
MHRA Inspector	UK MDR 2002 evidence + UKRP mandate + per-UK-device evidence + UK Vigilance.	On request.
SOC-2 Auditor	Cybersecurity Log SOC-2 Evidence Locker (per CC# per period); Access Review records; Backup tests; Encryption inventory; Security training; Incident log.	Type-2 attestation period.
ISO 27001 Auditor	ISMS Document Register; Risk Register; Annex A applicability statement; control evidence; Internal audit; Management review.	Stage-1 + stage-2 + annual surveillance + 3-year recertification.

Frequently asked questions

What does an FDA inspector see in qmsWrapper?

During an FDA inspection, qmsWrapper shows the inspector the CAPA log, complaint files, design-controls evidence and QMSR clause coverage, alongside cybersecurity evidence, the AI governance log and the AI human-in-the-loop audit. These are surfaced for the inspection scope rather than the full daily operator view.

What does a Notified Body auditor see in qmsWrapper?

For annual surveillance and unannounced visits, an NB auditor sees every log filtered by audit scope, the same dashboards the QMS manager uses, and the audit-signature chain. This gives the auditor scoped access to the underlying evidence plus the tamper-evident signature trail proving record integrity.