Greenlight Guru as a Medical Device software solution

#21
Hi okayfine!
I have looked at qmsWrapper, if you heard about. It's a really cheap eQMS software including a lot a features. We are currently evaluating it at it looks pretty good. I would also suggest you to have a look.
 
Elsmar Forum Sponsor
#22
Hey Sanda,

I'm sorry to hear that you didn't have a price quoted to you after receiving a demo and establishing if the solution met your needs. Do you remember the name of sales rep that you were working with?

I'd be happy to assure we get you the pricing you are looking for and answer any outstanding questions you may have.

Mike Gadus
Greenlight Guru
 
#23
We currently use Verse which is about to have a major upgrade, we tried to implement Greenlight Guru for nearly a year, but their workflows were so restrictive and unintuitive they actually put our system backwards, and they were so aggressive about a mature QMS finding issues and faults with their product to be honest I really wouldn't be happy to recommend them. The platform means the company works for it not it working for you and is very admin heavy. I've decided to stay with Verse and for the price this platform is configurable intuitive and definitely the superior product.
 

Sam Lazzara

Trusted Information Resource
#24
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.

From what I can see, GG and Verse cost more than what my startup clients with less than 10 persons are willing to pay. 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
Note: I am not affiliated with any of these providers.

I am a medical device quality system consultant, providing tailored document sets to clients that (so far) are not based on any particular eQMS. I will have to re-engineer my core document set since many of my legacy SOP Forms (that become records when filled out) will be replaced by eQMS data entry screens. As I review the eQMS providers, I am using my SOP Form fields as a comparator for the database fields in the eQMS software. If there are no such standard fields, I am looking to see if the software can be custom-configured to give me what I want.

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.

I had a call with Verse, and I believe that they are focused on serving mid-size to large-size firms with 100s and 1000s of eQMS users. Perhaps their pricing on a "per user" basis becomes affordable for the larger firms when you divide it by the number of users they have?
 
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William55401

Involved In Discussions
#25
This is a very interesting & relevant thread to a current challenge I am facing. Establish a new QMS for 10 person (or so) med device spec developer with an outsourced supply chain. I am just setting up my initial calls and demos for various eQMS providers. In my call with Green Light, I did learn they offer off the shelf SOPs that align to their work flows. This could really compress implementation timeline. Given that this thread is about 6 months old.....

Sam L. How did your evaluation go? What platform did you land on?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#26
As a general "Heads Up" (and this is in no way an opinion of their services and/or software): A number of posts in this thread were deleted (none recently) because they reeked of being "astroturf" posts for Greenlight Guru.
 

Ronen E

Problem Solver
Staff member
Moderator
#27
This is a very interesting & relevant thread to a current challenge I am facing. Establish a new QMS for 10 person (or so) med device spec developer with an outsourced supply chain. I am just setting up my initial calls and demos for various eQMS providers. In my call with Green Light, I did learn they offer off the shelf SOPs that align to their work flows. This could really compress implementation timeline. Given that this thread is about 6 months old.....

Sam L. How did your evaluation go? What platform did you land on?
I have no affiliation with Greenlight Guru. I did have a hands-on experience with their SW in a small startup company (not a long one).

In general I didn't like GG's system. I felt it was too rigid (non-customizeable), and in some aspects their approach/solutions were too convoluted / cumbersome / high-overhead, which was especially limiting in a startup environment. Plus, it was definitely not a collaboration tool, i.e. we had to develop the documents somewhere else, and then upload them to GG for control/maintenance/use.

I saw their ready-made SOPs (we didn't use them). Some of them were nothing but a shell, and others were nothing to write home about. Pretty average. I do have to admit I didn't read all of them.

In general, I don't recommend using canned SOPs (I've written about it many times in Elsmar). It looks enticing at first, but you'll have to put in quite a lot of work to make them (any, not just GG's) work for you, and you may also end up with excess baggage. This is true especially for a small startup. If you're going to invest work anyway, I'd much prefer to start with clean slate and build up something simple, robust and suitable for your org.

If I were you I'd invest a few hours in reading all the Elsmar threads discussing implementing an eQMS through a Wiki. It's worth it even if you'll end up not buying in.

I'm here to help.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#28
Also please note: Greenlight Guru can register here and post as long as they clearly identify who they are.
 

Sam Lazzara

Trusted Information Resource
#29
Sam L. How did your evaluation go? What platform did you land on?
The only platform I was able to evaluate in-depth is Grand Avenue Software (GAS). They have turned over the keys to me to learn their sofware, and most of the other companies only provided brief demos that were not extremely helpful and did not follow up very well on average.

My first experience with GAS was when one of my clients had me perform their first internal quality audit. They provided full read-only access to their GAS installation while I was performing the audit. That was a great opportunity to see how it functions; what it does and does not do.

Since that time, I contacted GAS directly. Knowing that I am a medical device QMS consultant, and understanding that I can link prospective customers to them, GAS has provided me with a fully working version of all of their modules, so I have been able to evaluate tailoring the core database to match my system procedures. I am waiting for a startup client who is interested in implementing GAS at the outset and requires a full tailored QMS document set to accompany GAS (i.e. dovetails with the GAS functions). My core system will need to be customized to work with any eQMS, and based on the good experiences and cooperation I have had with GAS, it is now my first choice for embarking on that adventure.

I don't think I need to say this, but I will anyway. 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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Ronen E

Problem Solver
Staff member
Moderator
#30
I don't think I need to say this, but I will anyway. 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.
I wholeheartedly second that. And yes, it does need to be stated once in a while because people seem to forget.
 
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