QMS software that doesn't fight you every time you open it.
V5 Ultimate is a modern eQMS for regulated manufacturers, labs, and device makers. Documents, CAPA, audits, training, change control, supplier quality — one platform, hash-chained audit trail, real ERP integration, no $250k/year price tag.
You searched 'QMS software' because the current stack is the audit risk.
Three places to find a current SOP — none of them are right
CAPA spreadsheets that nobody opens between audits
Training records that don't link to the documents people were trained on
Supplier qualification folder hasn't been touched since 2022
Change control runs over email, with screenshots
Your eQMS vendor charges per user per module per quarter
Everything an eQMS should do, in one place.
Document control
Effective dating, periodic review, controlled distribution, automatic training assignment on revision.
CAPA + deviation
Root-cause, corrective and preventive actions, effectiveness checks, full closure lineage.
Audits — internal and external
Plan, schedule, execute, evidence. Findings link to CAPA automatically.
Training + competence
Role-based curricula, training-on-revision, qualification status by person and by role.
Supplier quality
Qualification, requalification, scorecards, audits, change notifications — one supplier file.
Inspector-grade audit trail
Hash-chained, append-only, exportable. Every event on every record.
What changes when QMS stops being a chore.
- SOPs are findable in under 10 seconds, by anyone, on any device
- CAPA closure rate hits 100% because the system won't let you skip steps
- Training compliance goes from 'we think so' to a dashboard
- Supplier qualification lapses become impossible
- Audit prep falls from weeks to hours
Standards your auditors will check.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
QMS software, answered.
What is QMS software?
QMS (quality management system) software — also called eQMS — is the platform of record for the quality processes a regulated company has to run: documents, CAPA, audits, training, change control, supplier quality, deviations. V5 Ultimate runs all of these on one platform with a hash-chained audit trail.
Is V5 a real eQMS or just document control?
Full eQMS — documents, CAPA, audits, training, change control, supplier quality, deviations, complaints, management review. Not just a file vault.
Does V5 work for ISO 13485 medical-device companies?
Yes — V5 covers design controls, DHF/DHR/DMR, risk hooks (ISO 14971), CAPA, and post-market on the same platform.
How is V5 priced?
Flat platform pricing — not per user per module per quarter. See the pricing page.
Can we run the eBR on the same QMS?
Yes. Document control, training, eBR / eDHR, MES, and QMS are the same platform with one audit and one training footprint.
Replace your QMS in a quarter, not a year.
Free trial. Real migrations. No multi-year program.