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.
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.
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