Quality Leadership
See the state of the QMS without assembling it by hand every quarter.
VP and Director of Quality, QA Managers, Management Representatives and anyone who signs the Management Review.
Your week, before and after
The left column is how this work usually gets done. The right column is the same week with the records, evidence and reminders living in one place.
Your week today
- Management Review inputs are rebuilt by hand from CAPA logs, audit reports and complaint spreadsheets, and someone always asks for a number nobody has.
- Enforcement trends arrive second-hand, usually after a competitor is already in a warning letter.
- Every "are we ready for an inspection?" question turns into a week of interviews.
- Dual-control approvals live in e-mail threads that have to be reconstructed for the auditor.
Your week with VirtualBackroom
- Management Review pulls its ISO 13485:2016 §5.6.2 inputs from CAPA, audit, FMEA and complaint records already in the platform and flags the inputs that still need a human answer, instead of inventing one.
- Warning Letter Insights shows you which QMSR and ISO 13485 clauses FDA is actually citing this month, refreshed daily.
- Audit Coach lets the team rehearse an inspection against an AI investigator and hands you a scored debrief with the weak areas named.
- CAPA approvals run through a dual-control workflow (the author can never approve their own record) with a hash-chained history, not an inbox thread.
The tools behind it
Every tool links to its real page. Tools marked Pro or Premium need that plan; everything else works on a free account. Compare plans.
QMSR Exposure Check No login needed
A deterministic read on where a device company is exposed under the FDA QMSR, with a per-area report. No account needed.
Builds the ISO 13485:2016 §5.6 review record from data already in the platform and flags every required input that is still unaddressed. Never fabricates a number.
Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses.
Browser on Free; bulk analysis on Pro.Open, investigate and close corrective actions with a hash-chained history, dual-control approvals, and links from the FMEA line, complaint, deviation, 8D case or exposure row that raised them.
Practice FDA-style and ISO inspections against an AI investigator, with scored debriefs and weakness reports.
Three simulations a month on Free; unlimited on Pro.Ask one regulatory question to a council of models from OpenAI, Anthropic, Google and Perplexity; compare their cited answers with a consensus score and per-citation verified/unverified flags.
Acceptance sampling (ANSI/ASQ Z1.4), process capability (Cp/Cpk/Pp/Ppk) and Gage R&R computed by a deterministic engine, with optional labelled AI interpretation.
Requirements this role answers to
- ISO 13485:2016 §5.6 — Management review
- ISO 13485:2016 §8.5.2 — Corrective action
- FDA QMSR (21 CFR Part 820) — Quality management system regulation
Citations use the clause formats listed in our Standards Library. The FDA QMSR is cited at the Part level; withdrawn 21 CFR 820 subsections are never presented as current requirements.
Start with the free Exposure Check
No account and no upload. You get a per-area read on where your company is exposed under the FDA QMSR, and a clear picture of what the rest of the platform would add.
Prefer a reference your team can keep in its own tools? The transition checklist, the readiness checklist and the self-assessment also ship as Markdown files in the QMSR Knowledge Pack, Edition 2026-11, a one-time purchase with no account needed.
Other roles
What this page does not claim. VirtualBackroom.ai is advisory and training software. It does not replace your procedures, your regulatory counsel or an independent audit, and AI output is a draft for qualified human review. Deterministic tools (quality statistics, exposure scoring) are labelled as such; where a figure is not produced by one of them, we do not quote one. Plan tiers shown here reflect the current pricing. Read our AI Boundaries and Security pages for the full intended-use statement.