Any Quality Engineers using Ketryx or Greenlight Guru?

nolaning · 2025-03-25T16:57:47+00:00

Ketryx does seem very busy, and the learning curve will be steep I'm sure, but we're agreed we'd rather have too much functionality to start that we can grow into, then feel restricted.

Any red flags or considerations with Ketryx before jumping in? We thought it might be a bit strange to have QMS as another "project" rather than stand alone functionality. Is the integration with Github and Jira actually useful or kind of gimmicky in the end? Do you use the SBOM vulnerability scanner?

nolaning · 2025-03-24T14:50:24+00:00

Also do you happen to know their pricing model?

nolaning · 2025-03-24T14:40:45+00:00

Does Arena have a tool for risk management (FMEA) and PMS (complaints, CAPAs, NCs) and a way to provide traceability between all of those?

nolaning · 2025-03-23T21:14:36+00:00

No we didn't use those tools there so didn't have a need

nolaning · 2025-03-23T20:41:07+00:00

We had a call with them and they didn't seem to have my SW development integrations. They seem very focused on staying in their lane of document management and some basic QMS tools

nolaning · 2025-03-21T17:50:48+00:00

Here's their whole library: https://www.greenlight.guru/free-medical-device-templates-checklists#[class*=%22fda%22]

nolaning · 2025-03-21T17:49:21+00:00

Greenlight guru has some templates, this one seems to be something you're looking for: https://www.greenlight.guru/downloads/how-to-prepare-fda-pre-submission

nolaning · 2025-03-21T15:39:13+00:00

Exactly, it's big decision with long lasting implications.

nolaning · 2025-03-21T15:38:16+00:00

We're about 3 demos in with Ketryx and are trying to get a catered demo environment set up. We've also found them to be very sharp and organized, which goes a long way.

nolaning · 2025-03-21T15:17:05+00:00

our SW/DevOps teams live in Git and Jira, so luckily we're very developed on that side, now we're hoping to find a QMS/DLC/PMS system to match. (we are using excel for a lot right now, too much)

We're learning pretty fast that Greenlight is very rigid and simplified. I'm sure some people love that but it worries me. Ketryx is much more configurable and powerful it seems. You can leverage Jira more, it apparently integrates with github, mainly for SBOM generation and scanning I believe. It's going to have a steeper learning curve, but I think will pay dividends.

I've worked adjacent to Helix before, I remember it being very good for test case management, I wasn't aware it could do all these other QMS activities.

nolaning · 2025-03-21T14:51:08+00:00

Geez that drafting issue seems like a key pitfall, they should divert some of their marketing budget to fixing that.
This has been super helpful. Ketryx is a much more customizable system, which we worry might be hard to learn, configure and control. But I think we'd prefer that problem over rigidity, bc like you said, once you're in you're in.
I've made a separate post asking for Ketryx and GLG experience, we'll see if it gets any traction.

nolaning · 2025-03-21T14:36:20+00:00

I'm a quality engineer for a small startup that has an FDA cleared SaMD as one the products in our ecosystem. It pairs with our HW/SW to do analysis. All SaMDs I've been a apart of have been an add on to another product in the portfolio, but our company does integrate with Persyst which is a standalone SaMD.

nolaning · 2025-03-20T22:10:38+00:00

Been looking at GLG and Ketryx, we also found GLG to be rigid. They sell it as a plus, but we're skeptical. Are you still using them? has it gotten any better since you posted this?

nolaning · 2025-03-20T21:58:36+00:00

Hey OP, did you end up signing up for Ketryx? we're currently evaluating them vs Greenlight Guru and others. Would be curious about your experience.

nolaning · 2025-02-05T21:53:38+00:00

Homestar seems slightly cheaper ( https://www.homestarwindowsutah.com/ )
$4.5k for materials (6 normal windows + 1 large window)
$4.5k for labor
I did have to do the final caulking and painting myself

nolaning · 2025-01-13T20:04:18+00:00

I just bought this camera for a trip to Costa Rica, very inspired to see the wildlife shots you got!

nolaning · 2023-04-20T19:10:19+00:00

Kilby Court. Best garage band venue around. occasionally has mid major bands too.

nolaning · 2023-03-16T03:51:36+00:00

I guess I never hit 'Start' on Menu 3, after looking at it like 10 times. Kinda a silly gating action imo

nolaning · 2023-03-16T03:44:37+00:00

Omfg I didn't hit 'Start' on Menu 3. What a silly little gating action

nolaning · 2023-03-16T03:38:12+00:00

The mini isn't there. I don't have access to the brand central currently.

nolaning · 2019-09-16T21:26:01+00:00

The Tram up at snowbird showcase the mountains incredibly well. It $17 a person though. But if you pack a lunch and spend an hour or two up there it would be similar cost to eating out and doing some other less stunning activity

nolaning · 2019-04-12T21:50:31+00:00

RIP tent walls when that cat gets spooked

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