Greenlight Guru as a Medical Device software solution

I have interacted with the Greenlight Guru app a bit. I would describe it as a pretty immature app - they have clearly spent a lot of money on marketing, and many of their marketing materials are very nice (and often informative), but the app itself is pretty inflexible and I don't get the impression they are spending as much on experienced developers as they should.

Updates are relatively frequent, so there's clearly a drive for improvements, but this also means quality is constantly needing to account for the impact of those changes. Many of the changes are cosmetic, and fairly important tickets may stay open for months if the Greenlight Guru team don't happen to have them on their upcoming changes.

I would recommend picking a more mature and stable platform at this point in time, especially if you're going to shell out a lot of money for it.

Thank you for the great responses. I agree brains are needed. I try to use mine often. For this engagement, client has zero device experience. They don't know what they don't know. My view is that software control on workflows, approvals, and record keeping can be a big plus. I agree that writing the procedures, in collaboration with the client, is where a great deal of learning occurs. The feedback here has been helpful. I will update this thread as I complete evaluations of Green Light (and others).

Enternationalist said:

Updates are relatively frequent, so there's clearly a drive for improvements, but this also means quality is constantly needing to account for the impact of those changes. Many of the changes are cosmetic, and fairly important tickets may stay open for months if the Greenlight Guru team don't happen to have them on their upcoming changes.

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I feel that this is quite an accurate description (at least by early 2019 it was).

William55401 said:

My view is that software control on workflows, approvals, and record keeping can be a big plus.

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In my experience that was a weak point in GG. The built-in workflows were either too restrictive or unclear (sometimes both, if you can imagine something like that), and approvals control was very much open-ended, as in each document required setting up its own review and approval routing with very little pre-defined limitations or hard-guides. I got the impression that record-keeping control was adequate, but didn't have the length of experience to really say.

Ronen E said:

In my experience that was a weak point in GG. The built-in workflows were either too restrictive or unclear (sometimes both, if you can imagine something like that), and approvals control was very much open-ended, as in each document required setting up its own review and approval routing with very little pre-defined limitations or hard-guides. I got the impression that record-keeping control was adequate, but didn't have the length of experience to really say.

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Very much this. In GG you are very restricted in some things and cannot enforce logical controls on others. Particularly if you are just setting up a new system, bolting on a QMS such as this may shape your procedures in an unhelpful way. Record-keeping was okay, but plagued by minor problems such as the PDF-converted formatting not looking as expected.

On a tangent, I have also had some interaction with Verse solutions. It seemed like a rather high overhead for setup and administration, but I also got the impression it was a fairly powerful tool with decent flexibility. The user experience was not super intuitive, but pretty solid, with a more traditional database clearly underlying the implementation. I didn't see it long term use, but would consider it a more flexible and full solution than GG if you can take the time to set it up appropriately. It is still not much of a platform for collaboration, however.

If anyone reading this is trying to decide on a solution, I would strongly consider if your company can afford to dedicate a few experienced software engineers with medical device quality experience to implement in-house solutions. QMS and Document Management systems are often the unspoken core of your business - it your single most used tool. Spending the money to make it meet your needs, to own it, and to be able to improve it may very well be worth it.

If I were setting up a new system in the future (and were lucky enough to have the money and time for it), I'd invest in a managed data service (AWS, perhaps), a good full-stack software engineer to implement and maintain a system, and a UX/Design/Process Improvement professional dedicated to helping the tools match the needs. I think many medical devices companies are not ready or able to recognise the value of such a set of employees, though!

Enternationalist said:

I would strongly consider if your company can afford to dedicate a few experienced software engineers with medical device quality experience

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(My emphasis)
You're writing it as if these individuals are common. I only knew one person who properly checked all these boxes, and I have a strong feeling that they are quite hard to find in any given single location!...

Enternationalist said:

QMS and Document Management systems are often the unspoken core of your business - it your single most used tool. Spending the money to make it meet your needs, to own it, and to be able to improve it may very well be worth it.

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Agreed. That's why I think implementing a QMS on a Wiki (I call it a wQMS) may be a good, cost-effective idea, provided that it's implemented carefully.

Enternationalist said:

If I were setting up a new system in the future (and were lucky enough to have the money and time for it), I'd invest in a managed data service (AWS, perhaps), a good full-stack software engineer to implement and maintain a system, and a UX/Design/Process Improvement professional dedicated to helping the tools match the needs. I think many medical devices companies are not ready or able to recognise the value of such a set of employees, though!

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This is the kind of description that I would have started with "In an ideal world..."
But then the description is usually followed by "...But we don't live in an ideal world."

Ronen E said:

(My emphasis)
You're writing it as if these individuals are common. I only knew one person who properly checked all these boxes, and I have a strong feeling that they are quite hard to find in any given single location!...

Agreed. That's why I think implementing a QMS on a Wiki (I call it a wQMS) may be a good, cost-effective idea, provided that it's implemented carefully.

This is the kind of description that I would have started with "In an ideal world..."
But then the description is usually followed by "...But we don't live in an ideal world."

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Agreed. Even when you find such individuals, they aren't exactly cheap.

Enternationalist said:

Agreed. Even when you find such individuals, they aren't exactly cheap.

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LOL x10

Sam Lazzara said:

QMS software is not a replacement for brains. The software does not run the quality system; people do, and if they do not have enough experience, intelligence, common sense, and good technical/business decision-making skills (and maybe good coaching and mentoring) they will fail.

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I was a medical writer back when dinosaurs first invented word processing software. I was an early adopter and often asked for my opinion. My opinion was that, if you are good writer, a word processor will help you write well faster. If you are a bad writer, it will help you write badly faster too. The principle remains the same.

William55401 said:

For this engagement, client has zero device experience. They don't know what they don't know. My view is that software control on workflows, approvals, and record keeping can be a big plus.

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I have never used any eQMS, but this topic is a perennial one in the RAPS forum, so I'll share some wisdom from there, FWIW. The slight consensus is usually that a company should not try to implement eQMS until it has implemented QMS, which is to say "on paper." (There was one discussion in which the question of whether PDF and Word documents are "on paper." The strong consensus was yes.)

I concur with this as another general principle, but exponentially more so when the company is a medical device company. They need to learn what they need to know. I will further step briefly on my soapbox to say that I'm way past fed up with companies that do not have enough experience, intelligence, common sense, and good technical/business decision-making skills to be messing around with medical devices, and yet somehow feeling entitled to make money off of them anyway. [Stepping down now.]

Other advice from the RAPS forum is to think carefully about potential risks before putting any data or information that is proprietary, confidential, or otherwise mission-critical to your company in the cloud. You are essentially giving it to who knows who, to store who knows where. The problem with applying this wisdom to startups is that many of them are not willing to invest in good cyberprotection for their data themselves, so they might in fact be better served by a cloud-based system, IF that system is reasonably well protected.

Watchcat said:

The slight consensus is usually that a company should not try to implement eQMS until it has implemented QMS, which is to say "on paper."

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I'm glad you convey this as your take on the RAPS forum consensus, not as an absolute truth. I would agree in some cases but not in all. Pros and cons should be considered on an individual company basis.

Watchcat said:

I'm way past fed up with companies that do not have enough experience, intelligence, common sense, and good technical/business decision-making skills to be messing around with medical devices, and yet somehow feeling entitled to make money off of them anyway.

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1. How is it different from other fields?...
2. What constitutes having "enough of <all the above> .... to be messing around with ..."? Like in biological evolution - a "successful" organism is one we see around, not in decline - in capitalism, if someone is making money off of something it is considered to be the ultimate indication that their enterprise has the right to be around. You don't like it?... Too bad, capitalism is here to stay and the trend doesn't seem to be "more regulation".

Watchcat said:

Other advice from the RAPS forum is to think carefully about potential risks before putting any data or information that is proprietary, confidential, or otherwise mission-critical to your company in the cloud.

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This is not necessarily related to eQMS.
1. One can implement a full eQMS/wQMS on one's own in-house (or off-site location) server.
2. A lot of non-QMS proprietary data is spun-off, by many, to the cloud via a plethora of services and tools. Google Drive / Dropbox / One Drive / iCloud anyone?