# VirtualBackroom.ai

> Advisory and training platform for medical-device quality and regulatory teams (FDA QMSR, ISO 13485, EU MDR) and general supplier quality (ISO 9001, IATF 16949, AS9100D). Deterministic exposure scoring and quality statistics, a multi-model AI council with citation checks, audit simulations, and QMS records (CAPA with dual control, complaints, management review, process validation, supplier quality). Advisory only: it does not replace procedures or counsel and never files anything with a regulator.

Help guide version 2026-10-14. Sign-in is Google only; an agent needs a session the account owner provides.

## Help guide

- [Help Guide, plain text](https://virtualbackroom.ai/help/guide.md): every screen, exact button and field labels, step-by-step tasks, plan gating, enforced conventions, troubleshooting and the rules for AI agents. Read this before operating the app.
- [Help Guide, JSON](https://virtualbackroom.ai/help/guide.json): the same content as structured sections and blocks.
- [Help Guide, HTML](https://virtualbackroom.ai/help): the human-readable page.

## Key pages

- [Landing page](https://virtualbackroom.ai/): what the product is and who it is for.
- [QMSR Exposure Check](https://virtualbackroom.ai/exposure-check/): free, public, no upload; deterministic per-area exposure read.
- [Pricing](https://virtualbackroom.ai/subscription/pricing): Free, Pro, Premium and Enterprise plans.
- [QMSR Knowledge Pack](https://virtualbackroom.ai/pack): dated Markdown reference files on the QMSR (21 CFR Part 820), FDA inspections, Part 11 / Annex 11 and twelve jurisdictions; one-time purchase, no account; free sample at https://virtualbackroom.ai/pack/sample.
  - [Sample page: QMSR at a glance](https://virtualbackroom.ai/pack/sample/qmsr-at-a-glance): The regulation's name, dates, incorporation of ISO 13485 by reference, the six retained sections and the three changes that matter.
  - [Sample page: Crosswalk: former QSR to ISO 13485](https://virtualbackroom.ai/pack/sample/crosswalk-qsr-to-iso-13485): 29 rows: each former QSR section and title mapped to the ISO 13485:2016 clause number and title it now arrives through, with the retained FDA section where one applies.
  - [Sample page: QMS areas and OAFRs](https://virtualbackroom.ai/pack/sample/qms-areas-and-oafrs): The six QMS areas and four other applicable FDA requirements in Compliance Program 7382.850, each with its elements and the clauses and sections evaluated.
  - [Sample page: United States](https://virtualbackroom.ai/pack/sample/united-states): United States: regulator, QMS basis, market-access route and primary instruments with official links.
- [Product tour](https://virtualbackroom.ai/demo/qms-os-tour/): public self-service demo on demo data.
- [AI Boundaries](https://virtualbackroom.ai/ai-boundaries): intended use and the limits of the AI features.
- [Security](https://virtualbackroom.ai/security): security posture and data handling.
- [Methodology](https://virtualbackroom.ai/methodology): how the warning-letter corpus and exposure engine work.
- [FAQ](https://virtualbackroom.ai/faq) and [About / changelog](https://virtualbackroom.ai/about).
- [API documentation](https://virtualbackroom.ai/api/docs): programmatic access, for integrators rather than browser agents.

## Pages by professional role

- [Quality Leadership](https://virtualbackroom.ai/for/quality-leadership): See the state of the QMS without assembling it by hand every quarter.
- [Regulatory Affairs](https://virtualbackroom.ai/for/regulatory-affairs): Cited answers across FDA, EU MDR and ISO without re-reading the regulation every time.
- [Quality Engineering & CAPA](https://virtualbackroom.ai/for/quality-engineering): Investigations that close with evidence, linked to the risk they came from.
- [Internal Audit](https://virtualbackroom.ai/for/internal-audit): Audit the way FDA will, before FDA does.
- [Supplier Quality (Medical Device)](https://virtualbackroom.ai/for/supplier-quality): Supplier controls you can defend under ISO 13485:2016 §7.4.
- [Design Assurance & Risk](https://virtualbackroom.ai/for/design-assurance): Risk files that stay current while the design changes.
- [Validation & Manufacturing Quality](https://virtualbackroom.ai/for/validation-manufacturing): Protocols, capability and gage studies with numbers you can show an inspector.
- [Complaints & Post-Market Surveillance](https://virtualbackroom.ai/for/complaints-post-market): Every complaint logged, screened and visible in the Management Review.
- [Document Control & QMS Administration](https://virtualbackroom.ai/for/document-control): Know which procedures are missing before the auditor asks for them.
- [Founders & Executives](https://virtualbackroom.ai/for/founders-executives): Understand your regulatory exposure before you hire for it.
- [Quality & Regulatory Consultants](https://virtualbackroom.ai/for/consultants): Scope engagements from evidence and leave clients with a system, not a binder.
- [Supplier Quality — Automotive, Aerospace, Food & ISO 9001](https://virtualbackroom.ai/for/general-industry-supplier-quality): AIAG tools and multi-standard gap analysis for suppliers outside medical devices.
- [Certification Candidates & Career Changers](https://virtualbackroom.ai/for/certification-candidates): Practise auditing and regulatory reasoning against real enforcement data.
- [All roles](https://virtualbackroom.ai/for/)

## Optional

- [Privacy](https://virtualbackroom.ai/privacy), [Terms](https://virtualbackroom.ai/terms), [Data processing addendum](https://virtualbackroom.ai/dpa).