Internal Audit
Audit the way FDA will, before FDA does.
Internal auditors, lead auditors and audit programme managers running the ISO 13485:2016 §8.2.4 schedule.
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
- Audit checklists are copied forward year to year and drift away from what regulators currently cite.
- New auditors learn interviewing technique on live audits.
- Findings are written up long after the walk-through, from memory.
- It is hard to prove the programme covers every clause and every process.
Your week with VirtualBackroom
- Audit Coach runs a multi-turn mock inspection against an AI investigator, FDA-style or ISO-style, and scores the responses.
- Warning Letter Insights shows which clauses are being cited in current enforcement, so checklists follow the evidence.
- The Standards Library and regulatory mind maps make clause-to-process coverage visible when planning the schedule.
- Compliance Exposure rows you confirm as real gaps promote to DRAFT CAPAs with the clause and both score layers recorded as provenance, labelled as self-assessment rather than audit findings.
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.
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.Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses.
Browser on Free; bulk analysis on Pro.Browse every standard the platform can cite, with the clause formats the citation validator accepts.
Visual maps of how regulations, standards and QMS processes connect.
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.
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.Requirements this role answers to
- ISO 13485:2016 §8.2.4 — Internal audit
- ISO 9001:2015 §9.2 — Internal audit
- 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.