QMS · AUDITS
✦ Available standalone for audit firms →

The whole audit, in one place.

From audit setup through final report — every part of an audit lives in Syneris, with Iris drafting the busywork and even running periodic audits on a cadence. Built for auditors. Used standalone or as part of your full QMS. You stay in control.

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✦ IRIS
on every step
of the audit
AUDIT SETUP
Schedule sent
to auditees
STANDARDS
ISO 13485, with
Iris guidance
GAP ASSESSMENT
Iris reads docs
against clauses
EVIDENCE
Tracked in
one thread
INTERVIEWS
Q&A logged
with notes
FINDINGS
Major · Minor
Obs · OFI
AUDIT REPORT
Auto-drafted
at close
PERIODIC
Iris runs them
on a cadence
WHAT YOU GET

A complete audit workspace.

From audit setup through final report — one workspace, with Iris drafting the busywork at every step. Run audits yourself with Iris assisting, or set up periodic audits and let Iris run them on a cadence.

Audit setup, sent
Schedule, scope, and notice — sent directly to auditees. No more email chains kicking off every audit.
Standard Browser, with Iris
ISO 13485 clause-by-clause with common nonconformities, interview probes, and evidence to request — all suggested by Iris.
AI gap assessment
Iris reads auditee documents against specific clauses and surfaces gaps before the audit even starts.
Requests + interviews
Send evidence requests to auditees and log interview Q&A — with review notes attached, all in one thread.
Findings, clause-linked
Major NC, Minor NC, Observation, OFI — each tied to clauses, evidence, and source records.
Audit report, auto-drafted
Final report drafted at audit close — findings, evidence, interview notes, all assembled. You review and sign.
Iris-conducted audits
Set the scope and cadence — Iris runs the audit on schedule and queues findings for your review.
★ FLAGSHIP CAPABILITY

Iris on the audit team — two ways.

Iris assists you when you're running the audit, and runs audits for you when you're not. Same engine. Same standards. Same connected findings. You stay in control.

✦ IRIS-ASSISTED, END TO END

Iris on the audit, end to end.

Pick a clause and Iris drafts the pre-audit playbook. Run gap assessment across hundreds of auditee documents in one click. When the audit closes, the final report is already drafted. Hours of work, gone.

✦
Common nonconformities — what auditors typically find against this clause
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Interview probes — targeted questions to surface evidence
✦
Objective evidence to request — exactly which records to ask for
✦
Gap assessment, in one click — Iris reads hundreds of auditee documents against your selected clauses
✦
Audit report, auto-drafted — findings, evidence, and notes assembled the second the audit closes
Standard Browser | ISO 13485:2016 · §8.5.2 ✦ Iris generated
COMMON NONCONFORMITIES
• No documented root cause analysis for closed CAPAs
• CAPAs closed without effectiveness verification
• Lack of trend analysis across nonconformities
INTERVIEW PROBES
• Walk me through how you closed CAPA-00043.
• How do you verify a CAPA is effective?
• Show me a recent root cause analysis.
EVIDENCE TO REQUEST
• 5 most recent CAPA records (closed)
• CAPA effectiveness verification reports
• CAPA trend analysis (last 12 months)
Add all to audit · Run gap assessment → Refine
Audits | Periodic · AUD-AUTO-0007 IRIS RUNNING
SCOPE
Document Control
ISO 13485 §4.2 · §4.2.4 · §4.2.5
CADENCE
Quarterly
Next: Q3-2026 · 03 July
✦ IRIS · CURRENT RUN Q2-2026
✓ Pulled 47 controlled documents in scope 8m ago
✓ Ran gap analysis against §4.2.4 5m ago
Drafting findings… now
PREVIOUS RUNS
Q1-2026 3 findings · 47 docs reviewed Reviewed
Q4-2025 1 finding · 42 docs reviewed Reviewed
✦ IRIS-CONDUCTED

Periodic audits, run by Iris.

Set the scope and the cadence. Iris pulls the in-scope records, runs the gap analysis, drafts findings — every quarter, every month, on whatever rhythm you set. Findings queue up for your review.

✦
Defined scope — pick the clauses Iris should audit against
✦
Set the cadence — quarterly, monthly, or any rhythm
✦
You review findings — Iris drafts, you approve. Always.
FLEXIBLE

Two ways to use Syneris Audit.

Run audits as a standalone audit firm, or use Audit as part of your full Syneris QMS — same engine, same Iris, different starting point.

FOR AUDIT FIRMS

Standalone for auditors.

Bring Syneris to your clients. Run their audits in your platform — Standard Browser, Evidence Requests, AI questions, gap assessment, findings, auto-drafted report — without forcing them into a full QMS purchase.

✓ Per-audit or per-seat pricing
✓ Bring your own clients, your own playbooks
✓ Export findings reports for your clients' QMS
✓ All Iris capabilities included
Reach out for audit firm pricing →
PART OF THE PLATFORM

Connected to your full QMS.

Findings tie back to documents, suppliers, equipment, training, and CAPAs. Audits show on supplier records. Evidence requests pull from your QMS automatically.

✓ Findings auto-link to records
✓ Iris reads your actual documentation
✓ Connected to suppliers, equipment, CAPAs
✓ One audit history, queryable forever
Reach out for platform pricing →

Run your next audit with Iris.

Bring us a real audit you have coming up — internal, external, or supplier. We'll show you what running it in Syneris looks like, end to end.

Book a demo →