Comparison

TLM vs Greenlight Guru

Both are real quality systems — but they’re built for different teams. Greenlight Guru is purpose-built for medical device. TLM is the flexible, complete QMS for growing manufacturers across every regulated industry — with a dedicated rep, AI built in, and a fraction of the cost. Here’s an honest side-by-side.

A fair comparison · we’ll tell you when the other guy is the better fit

Technicians running a regulated manufacturing line in a cleanroom
Fits your industry
✓ Medical device · aerospace · electronics · food
One QMS — not medtech-only
The short answer

Which one is right for you?

Choose Greenlight Guru if…

you’re a well-funded, medical-device-only company that wants a platform shaped entirely around established MedTech workflows — and can invest at the premium tier.

Choose TLM if…

you want a flexible, complete QMS that molds to how you already work, spans regulated industries (medical device included), comes with a dedicated rep who stands it up with you, and costs a fraction of enterprise — with Claude doing the heavy lifting.

Side-by-side

TLM vs Greenlight Guru, line by line

TLMcomplete quality + ops
Greenlight Gurumedical device only
Best for
Growing manufacturers standing up their first real QMS — or upgrading from a rigid one
Medical-device teams wanting a MedTech-specialized platform
Industries
Any regulated manufacturer — medical device, aerospace, electronics, food & more
Medical device (MedTech) only
Design control / DHF
Native DHF/DMR/RMF/HFE document control, design & process FMEA, control plans, and 510(k)/eSTAR submission toolingyes, natively
Deep, MedTech-specialized design controls & DHF
Content included
~60 interlinked procedures, ready to releaseincluded
Medical-device templates
Implementation
A dedicated rep builds it with you and trains your Management Rephands-on
Guided onboarding
Flexibility
Molds to how you already work
Purpose-built medical-device workflows
Deployment
Cloud · network · desktopyour call
Cloud only
How it’s hosted
Single-tenant — your own server, not shared with other customersyour own server
Multi-tenant SaaS — one shared platform for every customer
Staying validated
You control when updates apply — on your own server — and Validation Katas test only what changedyou control it
A validation package each release, but updates arrive on the shared platform’s schedule
AI direction
The “Easy Button” — Claude reviews & edits your docs, audits the whole system, and drafts your Management Review
Assistant for existing quality teams
Relative cost
A fraction of enterprise
Premium
Meeting & maintaining validation

The validation question most buyers forget to ask

Both TLM and Greenlight Guru give you a credible, risk-based validation story — GLG ships a validation package with each release, and that’s genuinely useful. The real question isn’t whether you can validate. It’s who controls your validated state — and how much testing each update actually costs you.

What to test — risk-based

Both follow the FDA’s Computer Software Assurance approach: test in proportion to risk, not everything. Table stakes — and TLM matches it.

How you test — Validation Katas

TLM proposes a concise, whole-workflow test for exactly what changed since your last validated version, grounded in your own configuration. You confirm it, run it on your sandbox, and sign — not a generic script to map to your use.

When updates land — you decide

The part a shared platform can’t match. On a multi-tenant cloud, updates arrive on the vendor’s schedule. On TLM you run on your own server — nothing changes until you’ve validated it and choose to apply it.

Who scopes it — Sensei Claude

Because TLM knows the exact changes to your system, it scopes the smallest relevant test set — the changes since your baseline, and nothing you didn’t touch.

Why single-tenant wins here

A multi-tenant platform serves every customer one shared application, so it can’t let one company freeze its validated version while others move on — and low-risk updates can arrive without notice. TLM gives each company its own server, so your validated state stays yours: you apply a change because you needed it and validated it — never because a release calendar pushed it to everyone at once. For a regulated team, that’s the difference between staying validated and re-validating on someone else’s schedule.

Plenty of QMS platforms are multi-tenant. A few enterprise systems are single-tenant — at enterprise prices, and they warn you off the very customization TLM is built around. Single-tenant, built to fit you, and priced for a growing team: that’s a combination we haven’t found anywhere else.

You can’t verify a vendor’s promises — but you can verify their architecture. Single-tenant is the evidence a vendor built around you, not their own margins.

TLM runs circles around one-size-fits-all competitors because our design follows one philosophy: the customer’s needs come first — not the vendor’s convenience.

Why teams make the move

What sends manufacturers from Greenlight Guru to TLM

Flexibility, not a fixed mold

TLM bends to your process instead of forcing MedTech-shaped workflows on you — a common reason teams outgrowing a rigid system switch.

Beyond medical device

Aerospace, electronics, food, contract manufacturing — TLM runs one complete QMS across regulated industries, not just MedTech.

A real person, hands-on

Your dedicated rep stands the system up with you and trains your Management Rep — not a ticket queue.

A fraction of the cost

Enterprise-grade, audit-proven results without the enterprise price — so a growing team can actually afford a real QMS.

A system, not a module bill

Greenlight sells capability à la carte — you buy modules, then buy more as you grow. TLM is one system, priced by company size and locked in: use five areas or all thirty, scale from ten users to two hundred, and the price doesn’t move. No per-module upsells, no nickel-and-diming.

AI that acts, not just advises

Claude reviews your documents against their standards, then edits them into a change order — and rolls the whole system up into a Management Review.

Complete on day one

~60 interlinked procedures ship written and ready to release — not a stack of blank templates to fill in yourself.

The AI advantage · TLM, multiplied by Claude

Human-led. Claude-multiplied.

Six features plus one capstone, built into the everyday work — Claude answers from your controlled documents, reviews them against your standards, edits them into change orders, and rolls your whole system up into a board-ready Management Review. All human-led.

See TLM, multiplied by Claude →
The honest bit

When Greenlight Guru is the better fit

Greenlight Guru has real medical-device depth and years of experience, and it’s locked in a mature, well-honed approach to design control. But a multi-tenant platform can only offer that approach one way — the same workflows, the same level of detail, for every customer. If that one size fits your company perfectly and cost isn’t a concern, Greenlight Guru is a genuinely strong, focused choice — and we’ll say so. TLM gives you medical-device design-control features too — with the added flexibility to shape each workflow to the level of detail your company actually needs, not the level a shared platform imposes on everyone. If you’re not sure which camp you’re in, book a demo and we’ll give you a straight answer.

Don’t just take our word for it

Rated 4.8 by real users.

Independently reviewed on the platforms quality teams actually use to choose their software.

TLM rated 4.8 on CapterraTLM rated 4.8 on GetAppTLM rated 4.8 on Software Advice

See it built around your process.

A 30-minute demo shows you the ~60 procedures, the Easy Button, and exactly how your QMS would come together — with the rep who’d actually set it up.

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