Module · Inspection readiness

Inspection readinessbe audit-ready every day, not the week before.

MasterControl-grade audit-pack export, but assembled live: batch records, deviations, CAPAs, training certs, calibration certs and supplier approvals for any date range. Filter by product, line, or regulation. Hand the auditor a USB or a read-only share link — they see exactly what you see, frozen at the moment of export.

Start free — no card
Signals from the floor

What changes once Always-on inspection readiness is live.

Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.

Time to first batch
90 days
validated, e-signed, live
Audit-ready records
0%
Part 11, immutable, queryable
Operator adoption
0%
kiosk-first, no training-week
Manual paperwork
100
eliminated at the step
Before / after

What changes the day you switch this on.

Before V5
  • Manual, paper-driven, and only audited after the fact.
  • Auditor visits become a binder hunt and an email war room.
  • Tribal knowledge in spreadsheets and shared drives.
  • Errors caught at month-end — too late to fix the batch.
With V5
  • One-click audit pack
  • Read-only auditor share link
  • Pre-flight checklist
  • Mock inspection mode

What you actually get

Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.

One-click audit pack

Pick a date range and a scope (product, line, regulation). V5 assembles a signed, indexed PDF pack with hyperlinked exhibits in under 60 seconds.

Read-only auditor share link

Scoped, expiring URL that lets a regulator or notified body browse the same dashboards you use — without giving them a login.

Pre-flight checklist

Daily check: open deviations > 30 days, overdue training, overdue calibrations, untrained operators on the schedule. Green dot or fix-it list.

Mock inspection mode

Run a self-audit against FDA 483, MHRA, BRCGS or notified-body checklists; findings auto-route to a real CAPA.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • Audit pack PDF in < 60 s
  • Scoped read-only auditor links
  • Daily pre-flight: deviations, training, calibration
  • Mock inspection → CAPA
Regulatory anchor

The clauses this satisfies

21 CFR 211.180 (records)21 CFR 820.180 (general requirements)ISO 13485 §4.2.5EU GMP Annex 11
Engineered on
21 CFR Part 11 e-signatures
Immutable audit trail
Multi-tenant RLS isolation
GS1-128 license plates
Two-way ERP adapters
Common questions

What buyers ask before they switch on Inspection readiness.

Got questions, or want to see it on your shop floor?

Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.