Audit-Defensible AI for Quality & Regulatory Professionals
Medical device and general supplier quality — FDA enforcement data, multi-standard mapping, and ALCOA+ audit trails on every AI output.
No account and no upload for the check: a per-area read on where you stand under the FDA QMSR.
Who built this and what it runs on
Built and reviewed by a credentialed auditor, not a model count. Neelank Tiwari audits the standard the QMSR incorporates; the technology below is what he runs it on.
- DEKRA ISO 13485 Lead AuditorThe standard the FDA QMSR incorporates by reference
- ASQ CMQ-OE · CQA · CMDA · CSQP · CQIAASQ-certified in quality management, auditing, medical devices and supplier quality
- Medtronic · Edwards Lifesciences · EndologixEnterprise audit readiness, supplier change control, FDA audit SME
- MS · PMP · MIT SloanTechnology and innovation management; AI in healthcare, pharma and biotech
Model AI Council
OpenAI · Anthropic · Google · Perplexity and other frontier models answer Council questions in parallel; the output stays a draft for your qualified review.
FDA-Investigator Simulations
Practice audits with scored debriefs. Find weaknesses before the real inspection ever happens.
Warning Letters Analyzed
1162+ deficiencies mapped to QMSR/ISO 13485 clauses, refreshed daily from FDA.
Everything a QMS leader needs
Seven integrated tools that turn regulatory work from reactive scrambles into a predictable cadence. Prefer to look first? Walk through the self-service demo on sample data.
Audit Coach
Practice FDA-style and ISO inspections with an AI investigator. Multi-turn questioning, scored debriefs, and targeted weakness reports help you train your team safely between real audits.
Gap Analysis
Upload procedures across 28 QMS document types and get a 0–100% readiness score against QMSR. AI identifies missing clauses, suggests remediation, and exports a board-ready PDF.
Council Mode NEW
Twelve SOTA models stream answers in parallel — OpenAI, Anthropic, Google, Perplexity. Compare specialist perspectives, see consensus metrics, and ground decisions in cited sources.
Warning Letter Insights
Every FDA medical-device warning letter, automatically fetched daily, with deficiencies mapped to 21 CFR / QMSR / ISO 13485 clauses. Spot enforcement trends before they hit you.
CAPA Management
Generate, track, and close corrective actions with a full audit trail and 21 CFR Part 11 dual-control approval workflow. Cross-link CAPAs to FMEA risks and source warning letters.
QMS OS Agent Beta
Supervised autonomous CAPA investigations. The agent drafts root-cause analyses and remediation plans; you review and approve every action via a one-click human gate.
FMEA Worksheet NEW
ISO 14971-aligned with AI-suggested failure modes from a 3-model council. Color-coded RPN matrix, CAPA cross-links, PDF/Excel export, and append-only audit history for traceability.
Built for your role
Pick the seat you sit in. Each page shows your week before and after VirtualBackroom.ai, the tools behind the change, and the plan each one needs.
Evaluating us for IT or security? Start with Security and AI Boundaries.
Simple pricing
Self-serve tiers for small teams. Managed Service overlay available on Premium and Enterprise.
Free
- ~5 AI regulatory scans/mo (a taste)
- Regulatory radar — browse alerts
- Compliance Exposure diagnostic
- Audit Coach (3 sims/mo)
- Warning Letter Browser
- 3 FMEAs / 20 items
Pro Most popular
- Unlimited regulatory scans & custom alerts
- Unlimited audit simulations
- Gap Analysis (28 doc types)
- Council Mode (12 models)
- Unlimited FMEA + CAPA
- QMS OS Agent (Beta)
- PDF / Excel exports
Premium New
- Everything in Pro
- Management Review & Process Validation
- Quality Statistics (sampling, Cp/Cpk, Gage R&R)
- Supplier quality bundle
- AIAG quality tools: PFMEA / DFMEA / 8D / PPAP / APQP
- Multi-standard gap analysis (ISO 9001, AS9100D, IATF 16949)
- Recall Effectiveness planner
- Priority email support
Enterprise
- Everything in Premium
- SSO + audit-trail export
- Custom regulatory frameworks
- Dedicated CSM
- Managed Service overlay
QMSR Knowledge Pack, Edition 2026-11
65 Markdown pages on 21 CFR Part 820 as it reads now, FDA inspections, Part 11 / Annex 11 and 12 jurisdictions, with front matter and citations. Opens in Notion, Obsidian, Git or an AI assistant. USD 129 per person; a dated edition, not a subscription.