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Greenlight Guru as a Medical Device software solution

joemar

Involved In Discussions
#61
I have this long-standing thing about people (not referring to anyone in particular, including not to anyone in this discussion) who come to a forum and ask for recommendations for or experiences with a service or product without providing any information regarding their selection criteria. I assume they don't have any. Enough said.

Ultimately, it is all about finding the provider or product that matches your needs, and there is never going to be a one size that fits all, or a "best," only the best for this particular set of needs. On the flip, it is all about defining the market with needs that your product or service is a good fit for.

Having said that, I don't judge a book by its cover, but like any book buyer, I give do consideration to the cover. Old cover, old book. Depending on the type of book, the content is probably is going to be a little or a lot different than a book published in the last couple of years. Do I care? Depends on what I'm looking for.
hopefully i provided more info below.
 
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Jim Ivey

Grand Avenue Software
#62
I have no problem providing more feedback. I figure the next person who reads these forums will have some more info, so it's helpful.

Aside from the UI, when i was researching EQMS systems, I basically came to the conclusion that there are two tracks: (1) systems that are essentially repositories for information, and (2) systems that help guide your regulatory process.

Grand Ave. generally falls in the first category. Like, yes, it's helpful because it takes you away from paper and gives you a platform to share documents, but given that it's pretty basic, it doesnt do any of the lifting for you. Some of the other systems have more integration with your processes, or even if they arent tailored, they still have connective tissue that helps the process. An example is that a lot of systems let you start a CAPA in the system, and then from in the CAPA you can start a Risk Assessment or an Engineering Change, or a deviation form... So when you look back at the CAPA, you realize that the Risk Assessment is directly connected to the CAPA and if flowed to the Engineering CHange... This is a basic example, but it is something you guys are missing. You're mostly a repository for documents, and that feels like paper. It doesnt let the computer system help much.

Obviously, there are more integrated systems and less integrated. and some require you to basically rebuild your procedures to fit the system. others are basically off the shelf or have some basic check boxes and connective systems that flow you into other related processes. I am not aware of Grand Ave having much of that at all. it's basically only a repository for documents. That's not bad if that's what you are going for, but it's not that hard to find systems with a lot more functions and pretty low prices. not everyone has to go full tilt to get a good system now. Correct me if Im wrong.

Joe
Thanks for taking the time for that detailed response, Joe! I feel uncomfortable monopolizing this thread when it was originally a question about another company, but I'm intrigued and want to keep asking questions. :)

I have to admit I'm surprised by the perception of Grand Avenue as the "first category" (repository of documents) rather than the second, especially about the CAPA module. We actually get knocked around sometimes by new customers learning the system for the opposite reason, because it is a very detailed, rigorous process that can feel overwhelming for a small organization: documenting the initial concern/opportunity, fleshing out the root cause analysis, developing an action plan, getting it approved, managing the implementation, tracking the verification of long-term effectiveness, etc. All of those steps in the process are managed as separate tasks by many people collaborating within a workflow, working against a set of structured business objects, and the system partitions out the individual responsibilities to each user, focusing on their particular subset of the information and actions to perform on task-specific pages. A single "CAPA" in our system ends up being represented by dozens of objects (corrections, root causes, corrective/preventive actions, related process impacts, supporting documentation for all of the tasks), and gets intricately tied to related processes (audits, issues, complaints, NCMRs, etc.). I think the fault we usually have struggle with is the other one you mentioned: While we try to make the system as configurable as possible, customers frequently end up needing to evolve some of their procedures to fit our recommended process.

Regardless, I'll take the feedback as a data point, and follow up with our sales team to see if they still have a record of your evaluation and any more notes that came out of it. Ideally the evaluation site you used might still be active, and maybe I can glean a little more insight from the test scenarios you ran through the system, to better understand where we missed your expectations.

Thanks again for the feedback, and take care!
 

joemar

Involved In Discussions
#63
Thanks for taking the time for that detailed response, Joe! I feel uncomfortable monopolizing this thread when it was originally a question about another company, but I'm intrigued and want to keep asking questions. :)

I have to admit I'm surprised by the perception of Grand Avenue as the "first category" (repository of documents) rather than the second, especially about the CAPA module. We actually get knocked around sometimes by new customers learning the system for the opposite reason, because it is a very detailed, rigorous process that can feel overwhelming for a small organization: documenting the initial concern/opportunity, fleshing out the root cause analysis, developing an action plan, getting it approved, managing the implementation, tracking the verification of long-term effectiveness, etc. All of those steps in the process are managed as separate tasks by many people collaborating within a workflow, working against a set of structured business objects, and the system partitions out the individual responsibilities to each user, focusing on their particular subset of the information and actions to perform on task-specific pages. A single "CAPA" in our system ends up being represented by dozens of objects (corrections, root causes, corrective/preventive actions, related process impacts, supporting documentation for all of the tasks), and gets intricately tied to related processes (audits, issues, complaints, NCMRs, etc.). I think the fault we usually have struggle with is the other one you mentioned: While we try to make the system as configurable as possible, customers frequently end up needing to evolve some of their procedures to fit our recommended process.

Regardless, I'll take the feedback as a data point, and follow up with our sales team to see if they still have a record of your evaluation and any more notes that came out of it. Ideally the evaluation site you used might still be active, and maybe I can glean a little more insight from the test scenarios you ran through the system, to better understand where we missed your expectations.

Thanks again for the feedback, and take care!
Just to be clear, one of the distinctions between the first and second category in my opinion is the interconnectedness of the various processes. so, for example, in some systems you can create a CAPA, and within that CAPA, it helps lead you to the right procedures to change, it automatically generates the risk assessment that is embedded into the CAPA and the Design File, and it works you through the flow chart to make sure you hit everything. Grand Avenue (i may be wrong, i have only a little experience with it), might have some of those functions, but it doesnt actually generate them. it still makes you remember to do them. no prompts, no capability for you to do the linking of various processes and such. which is why it's more in the repository category imho.
 
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