Audit-ready in 90 days — without the 18-month QMS project.
Whether you're prepping for your first FDA inspection, an ISO 13485 certification, a sponsor audit, or an investor diligence — V5 has a 90-day path that gets document control, CAPA, training, change control, supplier qualification and the Part 11 audit trail live, populated and inspectable. With a vendor-supplied validation package, not a 12-month CSV project.
What breaks without this.
The audit was scheduled before the system was bought
FDA gave notice. The sponsor confirmed a date. The auditor flew in. Now you have a quarter, not a year.
Spreadsheet evidence won't survive a 30-minute review
Excel CAPA logs, SharePoint SOPs and email approvals get a 483 by lunchtime. The auditor is looking for tamper-evident audit trails and attributable e-signatures — not screenshots.
Legacy QMS projects run 12–18 months
Custom forms, custom workflows, custom price tags, custom delays. By the time it goes live, the audit window has closed twice.
Investor / sponsor diligence asks for the same artifacts
Quality manual, controlled SOPs, training matrix, CAPA aging, supplier qualification status, change-control history, validation package. Without a system, every diligence cycle is a fire drill.
Records-by-execution. Compliance, by design.
Week 1–2 — kickoff, URS gap, validation plan
Vendor validation package handed over. URS gap-mapped to V5 configuration. Risk-based test plan agreed. Project signed off.
Week 3–6 — document control + CAPA + training go live
Existing SOPs migrated under e-sign with version history. Open CAPAs imported. Training curricula assigned and verified. The system of record changes on day 21.
Week 5–8 — change control, supplier qualification, complaints
Change-control workflows configured. Approved supplier list imported with qualification status. Complaint intake live. The audit-pack starts populating with real records.
Week 8–10 — eBR / kiosk on a pilot line (if in scope)
Recipe migrated, scales bound, operators trained, engineering batch run on the kiosk. Records-by-execution producing a real eBR.
Week 10–12 — gap test, internal audit, mock inspection
Validation gap testing closed. Internal audit walks a real batch end-to-end. Mock inspection with an external auditor. Findings closed. Day 90: inspection-ready.
What to look for when you're buying.
'Audit ready in 90 days' is a program, not a feature. Criteria below are what to demand.
Defined 90-day plan
What it tests: Is there a week-by-week program with named deliverables?
Why it matters: 'We'll help' isn't a plan.
V5: Published program with weekly deliverables; run by an assigned team.
Gap-assessment first
What it tests: Do the first two weeks produce a documented gap assessment?
Why it matters: Otherwise weeks 3-12 build on assumptions.
V5: Structured gap assessment with signed deliverable.
In-scope subsystems named
What it tests: Is the scope explicit — CAPA, change, training, doc, complaint, supplier, EM (if applicable), calibration?
Why it matters: Scope creep kills the timeline.
V5: In-scope subsystems named per program tier.
Mock inspection at week 10-11
What it tests: Is there a rehearsed mock inspection?
Why it matters: First time through the front door shouldn't be with FDA.
V5: Mock inspection with SME auditor at week 10-11.
Post-audit sustainment
What it tests: Is there a defined operating model after go-live?
Why it matters: Audit-ready is a floor, not a peak.
V5: Sustainment cadence and ownership defined at handover.
Spreadsheet vs legacy QMS vs V5.
V5's 90-day program vs consultant-led remediation vs DIY.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Fixed 90-day plan | N/A | Consultant SOW | Published program |
| Software included | N/A | Extra | Yes |
| Mock inspection | N/A | Optional | Native at week 10 |
| Sustainment | N/A | Contract ends | Defined operating model |
The clauses, verbatim — and how V5 answers each.
Cross-cutting clauses this program addresses.
Full subpart set: 211.22 QU, 211.25 personnel, 211.100 procedures, 211.180-192 records.
V5: Program subsystems align to each subpart cited.
QMS process approach across management, resources, product realisation and measurement.
V5: Program subsystems align to §4-8 clause set.
Electronic records and signatures.
V5: Enforced by platform across all subsystems in scope.
Step by step on the floor.
The 90-day program.
- 1Week 1-2
Gap assessment
Documented gap with owners and SLA.
- 2Week 3-4
Configure & migrate
Subsystems configured; open scope migrated.
- 3Week 5-8
Train & pilot
Trainer-of-trainers; pilot lines cutover.
- 4Week 9
Sustainment cadence
Cadence set; owners named.
- 5Week 10-11
Mock inspection
SME auditor runs mock; punch-list closed.
- 6Week 12
Handover
Ownership formalised; sustainment starts.
The math, with the assumptions visible.
The program is priced against a real audit deadline.
Time to audit-ready
Fixed plan with software included.
Consultant spend
One program, one price.
Programs typically deliver at 30-50% of remediation-only cost.
What changed on the floor.
Setting
A device site with a warning-letter deadline in 100 days.
Before
Multiple subsystems below par; consultants scoping 12-month remediation.
After
Program executed in 88 days; passed re-inspection at day 130.
Proof points
- Document control, CAPA, training, change control: live by week 6
- Supplier qualification + complaints: live by week 8
- Vendor validation package — IQ/OQ/PQ + URS traceability + risk assessment
- Mock inspection with external auditor included in 90-day path
- Inspection-ready evidence: audit trail, e-sig, periodic review queue, audit-pack generator
- Used by first-FDA-inspection startups, ISO 13485 certifying device makers, CMOs prepping sponsor audits, and PE-backed rollups standardising acquired sites
Built to satisfy
- 21 CFR 820 (QSR — medical devices)
- 21 CFR 211 (Pharma GMP)
- 21 CFR Part 11 (Electronic records & signatures)
- ISO 13485 (Medical device QMS)
- ISO 9001 (Quality management)
- EU GMP Annex 11 + Annex 15 (computerised systems, qualification)
Frequently asked questions
Is 90 days realistic for a real QMS go-live?+
Yes, for the scope above (document control, CAPA, training, change control, supplier qualification, complaints, Part 11 audit trail). Adding full eBR on multiple lines, or migrating ten years of legacy CAPA history, pushes the timeline. We scope what's truly inspection-critical vs. what can land in the next quarter.
What about validation — doesn't that take months?+
Customer-side validation is the long pole only when the vendor provides nothing. V5 ships IQ/OQ/PQ, URS traceability and a risk assessment; customer validation is gap testing on configuration-specific items. Typically 2–3 weeks of validation effort, not 6 months.
Will an FDA / ISO auditor accept a 90-day-old system?+
Yes — what they assess is whether the controls are in place and operating, not the system's age. A system that's three months old with a populated audit trail, signed SOPs, closed CAPAs, current training and a periodic review on the calendar passes inspection.
What if our audit is in 6 weeks, not 90 days?+
We have a compressed path that focuses on the inspection-critical scope: document control, CAPA, training, audit trail. Other modules go live on the normal 90-day curve after the audit. Honest answer: 4–6 weeks is achievable for a tight scope on a motivated team.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.