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.
FDA gave notice. The sponsor confirmed a date. The auditor flew in. Now you have a quarter, not a year.
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.
Custom forms, custom workflows, custom price tags, custom delays. By the time it goes live, the audit window has closed twice.
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.
Vendor validation package handed over. URS gap-mapped to V5 configuration. Risk-based test plan agreed. Project signed off.
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.
Change-control workflows configured. Approved supplier list imported with qualification status. Complaint intake live. The audit-pack starts populating with real records.
Recipe migrated, scales bound, operators trained, engineering batch run on the kiosk. Records-by-execution producing a real eBR.
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.
'Audit ready in 90 days' is a program, not a feature. Criteria below are what to demand.
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.
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.
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.
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.
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.
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 |
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.
The 90-day program.
Documented gap with owners and SLA.
Subsystems configured; open scope migrated.
Trainer-of-trainers; pilot lines cutover.
Cadence set; owners named.
SME auditor runs mock; punch-list closed.
Ownership formalised; sustainment starts.
The program is priced against a real audit deadline.
Fixed plan with software included.
One program, one price.
Programs typically deliver at 30-50% of remediation-only cost.
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.
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.
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.
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.
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.
Free trial, no card. Live in 7 days with guided onboarding.