Greenlight Guru as a Medical Device software solution

Watchcat

Trusted Information Resource
#41
I'm glad you convey this as your take on the RAPS forum consensus, not as an absolute truth.
Yes, it seemed worth adding some additional opinions from a different source, but I don't see it as authoritative. And I will repeat that it was a "slight" consensus. As for me, I've never been a fan of one-size-fits-all. But I'm opposed to implementing eQMS (or any software solution) when/because you know nothing about QMS (or whatever). In that case, you are not even in a position to establish vendor selection criteria appropriate to your needs.

1. How is it different from other fields?
Because medical devices can injure, maim, and kill people, is what most people would say. But that doesn't distinguish them from cars, planes, and many other products, except that medical devices are specifically intended to do the opposite, while cars and planes are pitched for transportation. So devices that injure, maim, and kill are essentially frauds, where cars and airplanes that do the same are just not very good cars and planes.

But mostly because it's my field and I don't like people who haven't a clue messing around in it. I don't care about automotive or aerospace.

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.
I didn't say anything about people who were making money, but about people who seemed to feel entitled to do so.

In any case, that's not a tenet of capitalism, which is about ownership, not existence or rights thereto. I don't know of any economic theories that bestow the right to exist on enterprises. This seems somewhat reminiscent of free market theory, but it would agree with me, because that theory holds that those who have the experience, intelligence, common sense, and good technical/business decision-making skills needed to develop and market the best services and products will make the most money as a result, while those who do not will lose the competitive battle, so clearly they are not entitled to exist. I'm quite the fan of the free market, and regret that it exists only in theory. Or maybe more like fantasy.

Google Drive / Dropbox / One Drive / iCloud anyone?
To each their own. Just speaking for myself, they'll get my data when they pry it off my cold, dead hard drive.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#42
I didn't say anything about people who were making money, but about people who seemed to feel entitled to do so.
This makes absolutely no sense to me.

But mostly because it's my field and I don't like people who haven't a clue messing around in it.
I just don't know what to say to that other than tough luck. Others, new people and companies, will learn with time. Think Tesla and SpaceX, for example.
 
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Watchcat

Trusted Information Resource
#43
This makes absolutely no sense to me.
I'd be happy to try to explain, but I'm not sure what doesn't make sense to you. There are those who make money and those who fail to make money. There are those who think they are entitled to make money and those who don't. I was talking about the latter, not the former.

I just don't know what to say to that other than tough luck. Others, new people and companies, will learn with time. Think Tesla and SpaceX, for example.
Nothing to be said, I don't think. I also don''t like mornings, but still they persist on coming around, day after day after day.
 

Ronen E

Problem Solver
Staff member
Moderator
#44
@Watchcat: To me it doesn't make a difference what people think they're entitled to. If they don't actually make money, they won't be around for long (as that business entity). And if they do make money, then regardless of what I (or you, or anyone else) think of them, they do have enough skills and knowledge a-la the capitalist system, which is about leveraging ownership (capital) in order to grow it (= "make money").
 

Watchcat

Trusted Information Resource
#45
@Watchcat: To me it doesn't make a difference what people think they're entitled to.
The difference is in the types of behaviors those who seem to think they are entitled to it (and I use "seem to" because that could just be spin) will engage in, versus the behaviors those who seem to think they have to earn it will engage in.

@Watchcat:regardless of what I (or you, or anyone else) think of them
I think a lot about them, but I don't think anything of them, if you are talking about some sort of moralistic posture. I'm not interested in saints versus sinners. I'm interested in the competencies needed to develop medical devices that offer value to healthcare versus the lack thereof.

@Watchcat: If they don't actually make money, they won't be around for lon.
That's the theory, yes. In practice, google "Theranos." Survived 15 years, blew $700 million, never produced anything but spin, never made a dime.

Theranos - Wikipedia

So now I'm thinking it depends on what you mean by "making" money. Free market theory assumes you "make" money by using your capital assets to produce goods and services that have value to the market. If that's what you mean, I come back to, I didn't say anything about people who make money. So you are talking about one thing, and I'm talking about another.

Also I realize I said "companies" and you are talking about "businesses." A company is just a legal entity. A business is a "going concern." The medical device space is littered with companies that are not going concerns. In fact, I wouldn't be surprised to learn that the former outnumber the latter. Some manage to be around for a very long time, guzzling down resources, without ever producing anything of value to healthcare.
 
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William55401

Involved In Discussions
#46
Back to software....
I completed a demo on Green Light (GL). GL did not have integrated training as part of a new / revised document work flow. They did have a training solution but it was more of a manual work around where each user would maintain a log. There would not be a way to get top level visibility to overall training status. GL also did not have a solution for Document Change Management. I wanted to be able to group documents and tell a Reason for Change and Description of Change story.
For these reasons, I have lowered GL on my list and am continuing to evaluate others.
 
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#48
continuing to evaluate others.
Any updates on testing other eQMS options? Any experience with Aligned Elements?

From my knowledge, I have been looking into these other solutions, which seem to be already quite established:
-Polarion ALM
-PTC integrity
-Aligned Elements Ch.
I do personally favor both Polarion and PTC integrity. Depends on the complexity level of the solution you want to aim for.
It has been 3 years since that comment. I wonder, if your opinion is unchanged about Polarion and PTC integrity, or perhaps you have a new favorite eQMS?

I have embarked on an eQMS Software as a Service (SaaS) search of my own, focused on lower-cost browser-based fully-hosted services with good ongoing validation support. The providers I am evaluating are as follows:
- Grand Avenue Software (most supportive of my evaluation journey so far)
- Zen QMS
- Simploud (runs under Salesforce)
- Propel QMS (runs under Salesforce)
- QMSwrapper
- Qualio
Without divulging the pricing of the firms I am evaluating, here is some general information:
- None of them appear to have an upfront, flat fee, but I am still checking on some of them.
- Their pricing is either on a "per user" basis, or a "per 5 users" basis, or a "per 20 users" basis.
- Some have pricing that is on a "per month" basis without any additional commitment, whereas others require a one-year commitment.
- Some breakdown their pricing based on the number of modules you are using. For example, one of the providers has 9 modules, with the increased cost as you add modules, on a non-linear sliding scale that favors adding more modules. The beauty of this is that when first starting up, firms usually only need 2-3 modules at the outset, with Document Control and Training being the foundation.
- Others provide their full capabilities (all modules) for the prices quoted.
Any update on comparing the capabilities of these eQMS services?
 

Sam Lazzara

Trusted Information Resource
#49
Any updates on testing other eQMS options? Any experience with Aligned Elements?


It has been 3 years since that comment. I wonder, if your opinion is unchanged about Polarion and PTC integrity, or perhaps you have a new favorite eQMS?



Any update on comparing the capabilities of these eQMS services?
This effort became too exhausting for me, in general. I realized that for each unique eQMS solution, the resulting tailoring to my system documents would need to be unique. And based on my consulting business model, it does not make sense to try to provide a document set for each eQMS. Having said that, I have spent the most time with Grand Avenue Software (just the Document Control and Training modules - fully hosted) and have concluded it can be a cost-effective solution.
 
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