Legacy QMS replacement — migrate off the dinosaur without an 18-month project.
Legacy QMS platforms locked you in with custom forms, custom workflows and a custom price tag. V5 migrates your documents, CAPAs, training records and change controls under e-signature — preserving the audit trail — and goes live in weeks. No re-validation marathon. No re-training a generation of users.
What breaks without this.
The renewal arrived. So did the price hike.
Legacy QMS renewals are a once-every-five-years opportunity to fix what's been broken for five years — or to lock it in for five more.
Custom-coded forms no one wants to touch
The original implementer left. The forms still work, mostly. Nobody dares change anything before a Part 11 inspection.
Users hate it — so they work around it
Shadow spreadsheets, email approvals, paper print-outs. The QMS becomes the system of record for last quarter, not for today.
Migration sounds scarier than it is
Most teams overestimate the cost of leaving and underestimate the cost of staying. The longer you wait, the bigger the migration backlog gets.
Records-by-execution. Compliance, by design.
Document migration with audit-trail preservation
Controlled documents, prior versions, approvers, signature events and effective dates — imported into V5 with the historical chain intact. The auditor sees one continuous record.
Open CAPAs and deviations come with you
In-flight CAPAs, deviations, NCRs and complaints migrate with their state, owners, due dates and linked records. Nothing closes in your old system that doesn't re-open in V5.
Training records and skills matrix
Curricula, completions and competency assessments import per learner. Re-training is only triggered for SOPs that actually changed in cutover.
Validation re-use, not re-do
V5 ships with a validation package (IQ/OQ/PQ, traceability matrix, risk assessment) that maps to your URS — so re-validation is targeted gap testing, not a fresh 12-month project.
Parallel-run cutover, not big-bang
Read-only access to the legacy system stays for the inspection window. New records open in V5; the old system retires once retention is met.
Proof points
- Typical cutover: 8–16 weeks vs. 12–18 months for legacy reimplementation
- Documents, CAPAs, training, change controls, complaints migrated under e-sign
- Historical audit trail preserved — not flattened to PDF
- Validation package included — IQ/OQ/PQ, URS traceability, risk-based test plan
- Migrated off MasterControl, TrackWise, ETQ Reliance, Veeva Vault Quality, Qualio, Greenlight Guru, Ideagen Q-Pulse, Intelex
Built to satisfy
- 21 CFR Part 11 (Electronic records & signatures)
- 21 CFR 820 (QSR — medical devices)
- 21 CFR 211 (Pharma GMP)
- EU GMP Annex 11 (Computerised systems)
- GAMP 5 (validation lifecycle)
- ISO 13485 §4.2 (documented information)
Frequently asked questions
Will we lose our audit trail when we migrate?+
No. V5 imports prior versions, approval events, signature metadata and effective dates from the source system, so the historical chain is preserved and inspectable end-to-end — not flattened to a PDF archive.
Do we have to re-validate everything?+
No. V5 ships a vendor validation package (IQ/OQ/PQ, traceability matrix, risk assessment) that maps to your URS. Customer-side validation focuses on gap testing — typically weeks, not the 6–12 months a legacy reimplementation requires.
How do you handle in-flight CAPAs and deviations?+
They migrate with their current state, owners, due dates and linked source records. Nothing has to be 'closed' in the old system to move; the cutover is parallel-run with read-only legacy access through the inspection retention window.
Which legacy systems have you migrated from?+
MasterControl, Sparta TrackWise / TrackWise Digital, ETQ Reliance, Veeva Vault Quality, Qualio, Greenlight Guru, Ideagen Q-Pulse, Intelex, Dot Compliance, Lonza MODA, Werum PAS-X (document & quality scope).
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.