Validation & Manufacturing Quality
Protocols, capability and gage studies with numbers you can show an inspector.
Validation Engineers, Manufacturing Quality Engineers and production QA who own IQ/OQ/PQ, process capability and measurement systems.
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
- IQ/OQ/PQ status is tracked in a folder tree and a tracker that disagree.
- Cp/Cpk and Gage R&R are calculated in whichever spreadsheet is nearest.
- Process validation records are rebuilt for every audit request.
- Nobody is sure which protocols were approved before execution started.
Your week with VirtualBackroom
- Process Validation keeps IQ, OQ, PQ, PPQ and TMV protocols as records with controlled status transitions, so an unapproved protocol cannot be marked executed.
- Quality Statistics computes capability (Cp/Cpk/Pp/Ppk) and Gage R&R with a deterministic engine following the AIAG SPC and MSA manuals; any AI interpretation is labelled as such and kept separate.
- Acceptance sampling plans come from ANSI/ASQ Z1.4 tables, not from memory.
- A protocol deviation can be promoted to a DRAFT CAPA that stays linked to the deviation and its protocol.
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.
IQ / OQ / PQ / PPQ / TMV protocol records with controlled status transitions.
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.
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.
ISO 14971-aligned FMEA with AI-suggested failure modes, a colour-coded RPN matrix, CAPA cross-links and PDF/Excel export.
Three FMEAs on Free; unlimited on Pro.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.Requirements this role answers to
- ISO 13485:2016 §7.5.6 — Validation of processes for production and service provision
- ISO 13485:2016 §7.6 — Control of monitoring and measuring equipment
- AIAG SPC Manual — Statistical process control
- AIAG MSA Reference Manual (4th ed.) — Measurement systems analysis
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.