Document Control & QMS Administration
Know which procedures are missing before the auditor asks for them.
Document controllers, QMS administrators and quality systems specialists who keep the procedure set complete, current and approved.
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
- Checking the procedure set against a regulation means a clause-by-clause matrix nobody wants to maintain.
- Approvals happen on paper or in a tool that cannot show who approved what, and when.
- Validating the software the QMS runs on is a project every time a vendor ships a release.
- Records retention rules are known to one person.
Your week with VirtualBackroom
- QMSR Gap Analysis reads your procedures across 28 QMS document types and lists the clauses with no covering document, with a PDF you can file.
- Dual-control approvals on CAPAs and FMEAs produce an audit trail with actor, action and timestamp.
- The Vendor Validation Pack gives you a versioned, date-stamped pack (intended use, traceability matrix, Part 11 capability statement) for validating this software under ISO 13485:2016 §4.1.6.
- The Standards Library shows every standard and clause format the platform supports, in one place.
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.
Upload procedures across 28 QMS document types and get a readiness score, missing clauses, and a board-ready PDF.
Overview depth on Free; full analysis on Pro.A versioned, date-stamped vendor pack (intended use, traceability matrix, Part 11 capability statement) for validating this software under ISO 13485:2016 §4.1.6.
Browse every standard the platform can cite, with the clause formats the citation validator accepts.
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.
A feed of regulatory changes relevant to device and supplier quality programs.
Browse on Free; custom alerts on Pro.Requirements this role answers to
- ISO 13485:2016 §4.2.4 — Control of documents
- ISO 13485:2016 §4.2.5 — Control of records
- ISO 13485:2016 §4.1.6 — Validation of computer software used in the QMS
- 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.
See where you stand today
New accounts are paused at the moment. The free Exposure Check still runs without one, and the self-service demo shows the whole QMS OS on sample data.
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.