V5 Ultimate vs Greenlight Guru
V5 Ultimate vs Greenlight Guru
Greenlight Guru is the most-loved QMS in early- and mid-stage medical-device companies — purpose-built for ISO 13485 and 21 CFR 820, with a strong design-controls module and a fast-onboarding cloud experience. V5 Ultimate competes for the same buyer but adds the manufacturing execution layer (MES + WMS) that Greenlight intentionally doesn't own. This is the honest version of where each one is the right answer.
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What each product actually is
Greenlight Guru is a cloud eQMS for medical devices — design controls (DHF, design inputs/outputs, risk per ISO 14971), document control, training, CAPA, complaint, audit and a Clinical module for post-market data. It is intentionally not an MES — manufacturing execution and Device History Records live in a separate system. V5 Ultimate is one platform: design-control-aware execution, eDHR self-building per serial, WMS, and the QMS objects (CAPA, deviations, change control) on the same stack.
Execution on the floor and eDHR
This is the big difference. Greenlight assumes the device is built somewhere else and the DHR is assembled into Greenlight after the fact. V5 is the build environment: the routing references the locked DMR revision, operators only see the current revision, every step is signed live, calibrated torque tools push readings directly, the UDI label prints at the workstation, and the eDHR locks to the serial the moment the final inspection signs. There is no end-of-batch reconstruction.
Design controls
Greenlight's design-control module is genuinely strong — DHF, design inputs/outputs traceability matrix, ISO 14971 risk, and the path through FDA 510(k) / MDR submission. V5 covers the same surface area (design inputs/outputs, RTM, ISO 14971 risk file linked to software requirements per IEC 62304) but with a more execution-centric flavour — the same RTM that proves your URS is tested is the spine of the qualification of the manufacturing system itself.
Deployment
Greenlight Guru is cloud-only. For most early-stage device manufacturers this is the right answer. V5 ships in two deployments: Lovable Cloud and V5 Ultimate On-Premises (containerised, air-gap capable, customer-owned keys and data). On-prem matters for implantable, defence-linked, or certain combination-product manufacturers who cannot send records off-site.
AI behaviour
Greenlight has shipped 'Guru AI' for document drafting and compliance assist. V5's AI layer is regime-aware — for a medical-device tenant it speaks DHR / DMR / UDI / DI+PI / GUDID / EUDAMED and uses ISO 13485 + 21 CFR 820 templates by default. Both vendors are explicit that AI does not e-sign; a qualified human always does.
Pricing model
Greenlight quotes per company per year on a tiered subscription, with bands for startup / growth / enterprise. V5 publishes per-user / month for Cloud and an annual term licence for On-Premises, with a free trial and no minimum seat count for self-serve evaluation. For very small startups Greenlight's startup tier is often cheaper; for sites with 50+ floor operators V5's per-user model usually wins.
Where Greenlight Guru is the better fit
Pre-market and early-commercial device companies whose primary need is design controls and DHF, organisations who outsource manufacturing to a contract manufacturer and only need the QMS, or buyers who value Greenlight's medical-device-only focus and reference base over a multi-industry platform.
Where V5 Ultimate is the better fit
Device manufacturers who own their production line and want eDHR self-building per serial, on-prem / air-gap requirements (implantables, defence-linked, certain combination products), sites with 50+ floor operators where per-user pricing wins, or combination-product manufacturers who need pharma BMR + device DHR on one stack.
V5 Ultimate vs Greenlight Guru
| Capability | V5 Ultimate | Greenlight Guru |
|---|---|---|
| Design controls (DHF, design I/O, RTM) | Yes — execution-linked RTM | Yes — flagship strength |
| ISO 14971 risk file | Yes — linked to software per IEC 62304 | Yes |
| CAPA + complaint + audit | Yes — tied to serial/lot | Yes |
| Execution on the floor (MES) | Native — kiosk, torque tools, gating | Not in scope |
| eDHR self-builds per serial | Yes — live as operator works | Assembled from inputs |
| UDI generation + GUDID-ready | Native — DI+PI at the workstation | Reference only |
| Warehouse + lot/serial genealogy (WMS) | Native | Not in scope |
| On-premises / air-gap deployment | Yes — containerised | Cloud only |
| Multi-industry per tenant (combo products) | Yes — pharma + device | Medical-device focus |
| Per-user pricing model | Per-user / month | Per-company tiered |
Frequently asked
Can V5 Ultimate replace Greenlight Guru?
Yes — design controls (DHF, RTM, ISO 14971 risk linked to software requirements), document control, training, CAPA, complaint, audit and supplier quality are all in V5. Most Greenlight migrations to V5 happen when a company moves from outsourced manufacturing to in-house production and wants execution + quality on one stack.
Does V5 support ISO 13485 and 21 CFR 820 to the same standard as Greenlight?
Yes — both are core regulatory targets. Greenlight's domain depth in design controls is genuinely strong; V5's depth is broader (eDHR, UDI generation, calibration lockouts, training-gated steps) because it covers execution as well as documents.
Is V5 a fit for a pre-market startup?
V5 has a free trial and no seat minimum, so a 5-person startup can use it. That said, if your only need today is DHF + design controls and you don't own a production line, Greenlight is often a faster fit until you get to commercial manufacturing.
Can we run V5 alongside Greenlight during a transition?
Yes — V5 has REST + webhook integration patterns and can take execution + post-market quality while Greenlight continues to own design controls until cutover at the next renewal.
See it on your shop floor.
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