In this episode, host Etienne Nichols sits down with Michaela Kivett, a seasoned medical device consultant at Greenlight Guru, to break down the complexities of implementing an electronic Quality Management System (eQMS). Drawing from her background in orthopedic implant contract manufacturing and pharmaceutical process engineering, Michaela shares firsthand accounts of the critical inefficiencies that plague traditional paper and generic electronic repositories like SharePoint or Google Drive.
The conversation centers around the strategic planning required to transition between quality management states. Michaela introduces a powerful moving house analogy, illustrating that simply dragging and dropping messy, legacy records into a new digital environment will not solve underlying organizational issues. Instead, a successful migration requires an intentional internal self-evaluation, a culture of quality, and a structured, room-by-room approach to data and process transfer.
Additionally, the episode highlights how forward-thinking MedTech companies are leveraging advanced tools, including artificial intelligence, to streamline their eQMS implementation. By using AI to scan documents for compliance deficiencies against standards like ISO 13485, categorize sprawling folders, and map out workflow updates, manufacturers can dramatically mitigate the transitional efficiency dip and establish a mature, robust foundation for future scale.
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Think of your QMS (Quality Management System) as the blueprint for an entire house. It represents the actual words, rules, regulations, and standard operating procedures (SOPs) that dictate how your company builds safe medical hardware.
The eQMS (electronic Quality Management System)Michaela Kivett:is the physical structure and construction material of the house. While you can build a rudimentary shelter out of cardboard boxes and tarps (like a disorganized SharePoint or a stack of paper binders), a true, specialized eQMS acts as a reinforced concrete foundation. It automates the pathways between rooms, handles notifications when a door is left open (like an outstanding training task), and ensures that every brick is stamped with a certified, immutable electronic signature.
"Organization is the most common pain point. And it's a very simple pain point. I think every industry probably feels that... but you underestimate exactly how many different documents and records you're going to be producing and how many different places they tie into each other." — Michaela Kivett
We want to hear from you! Whether you are currently trapped in a Rube Goldberg web of spreadsheets or in the middle of a major system migration, share your stories, questions, or future topic suggestions with us. We read every email and pride ourselves on sending personalized responses to our community. Drop us a line at podcast@greenlight.guru.
This episode is brought to you by Greenlight Guru, the only dedicated medical device success platform designed specifically for MedTech professionals. Moving away from scattered SharePoint files or paper binders requires a system built with regulatory compliance in its DNA. Greenlight Guru integrates your entire lifecycle by pairing a robust QMS (Quality Management System) solution to automate closed-loop quality processes with a powerful EDC (Electronic Data Capture) solution to streamline your clinical data collection. Stop tracking down signatures and driving back to the office to fix handwritten logbooks. Discover how you can turn your quality architecture into a strategic asset by visiting Greenlight Guru.
Etienne Nichols: Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode and with me today is Michaela Kivett, a medical device consultant at Greenlight Guru.
And today we wanted to talk about what an eQMS is or really maybe more along the lines of implementing an eQMS. What, why, when, how and who. I don't know.
We'll cover all of those W's plus the 1H but Michaela, how are you doing?
Michaela Kivett: I am good. I am excited. It's a Friday right now and the weather is beautiful. So excited to, to enjoy the weekend here.
Etienne Nichols: I'm probably excited for this recording to be over so we could actually get there, get outside.
Michaela Kivett: It's always fun to get to talk to you. So, I'm excited.
Etienne Nichols: I guess the, I guess the solution is we could have recorded this outside. I always think that after I look out the window. But anyway, good to be with you today and I'm excited to talk about this topic. Maybe we could talk about your background a little bit. I didn't want to just give you a, give a canned speech.
I wanted to talk a little bit about maybe your favorite things that you've done or are doing in your career. I know your quality is something that a lot of our medical device consultants live and breathe and you're part of that team that really has their finger on the pulse of what the customers of Greenlight Guru, which over a thousand customers that utilize our eQMs, all the different pain points that they have, whether it's implementing, whether it's post implementation, whether it's the actual submission, their ISO 1345 certified audit. I'm going to stop rambling. So, what do you.
Let's talk a little bit about your background and how you got to where you are here today.
Michaela Kivett: Yeah, absolutely. I'll say the thing I find most interesting is how unpredictable my path has been since graduating college. And I graduated at a very interesting time for the job market.
I graduated May of 2020. So, there's a lot happening in the world at the moment. I was very fortunate.
I had my job. I had a few of my classmates lose their jobs before they even got started because of the pandemic. But I hired onto a medical device manufacturer who's a contract manufacturer making orthopedic implants and I worked as a quality engineer for about eight months with them just in the heart of the pandemic and needed to make a switch.
I didn't want to live in Florida anymore, so I moved up to Indiana and I actually for a little bit, moved out of med device and moved into pharma. And I was working on vaccines at the time as a process engineer for a very, very large company.
So, a little different from my first company.
It wasn't ever my intention to leave the med device industry. It's truly where I'm most passionate about, but that's just where the work was. And I got great experience working with a very large company doing all sorts of things and knew I wanted to get back into quality and back into medical device.
And I'd actually known about Greenlight since I was in college and I saw a job posting come up and I thought, you know, this might be the right time to get back into quality and back into medical devices.
So, I interviewed here and accepted the job. And I love working here. I love all of my teammates. I learn from them every single day.
So, it's been a wonderful two years here with Greenlight.
Etienne Nichols: Yeah. And so, in that time, I'm sure. So, what's interesting to me about starting in 2020, because I was, I, I was a mechanical engineer long before that and I was very much in person for the longest time.
2020 was, it was really tough in a lot of ways, but it, it was a dream come true in the regard that I was now able to work from home, and I live wherever I wanted, you know, to a certain degree.
And that, that was, that was kind of huge. But from a medical device perspective, being in person is one thing. And you, you can do things on paper. You can just go to somebody's desk and say, hey, did you get this approved? Did you do this, that, and is it in your stack?
Then you go virtual. And so, you kind of have the same experience that nearly everyone in the industry, whether you've been here in 20 years, 2020 was a demarcation of we're going to do things differently from now on, whether it's, get an eQMS, use SharePoint, use, whatever it is.
So, you've seen a lot of that.
What are some of the pains people go through?
Michaela Kivett: Oh, goodness. In one of, in one of my roles, and I will say it's interesting how working on site doesn't necessarily mean you can get things done faster. I remember spending a lot of time actually trying to track People down physically.
When it was a large site, it covered like a hundred plus acres. So, if you couldn't find someone, you spent a lot of time tracking them down.
So, communication, as silly as it seems when they should just be right next to you, usually just reverted back to teams or Outlook.
So, tracking people down.
We had problems with version control, so we were making updates to our procedures so rapidly that.
And there is no notification system that we would have multiple people with the same document making the same red lines in different departments and then submitting it to document control.
I remember making our document control mad because I submitted an update that she was already revisioning the same document.
So, miscommunication there.
And I remember I had; I got called back to site because I signed off on a training incorrectly. So I had to drive like another go back in to recorrect my handwritten signature because I didn't sign with what I had put in the logbook.
I mean, there's lots, there's lots of pain points that I experienced.
And it's just inefficiency is really the amount of time you spent tracking down people to correct what we might say is nitpicky stuff, but is really, really important in the industry.
You know, maintaining signatures and correct document versioning.
Etienne Nichols: Yeah, I almost look at them as like holes in the fence if, you know, okay, so I'm, I'm off grid. I'm rural. We have, you know, you have goats, rabbits, everything else.
If you have a hole in the fence, it seems like a little thing. It's not a big deal if you're surrounding, you know, 100 acres with a fence. Okay, well, that's actually a pretty big deal for some reason. They always find it. And I think it's the same way with an FDA investigator.
I'm not comparing them to a goat by any means. I have all respect for an FDA investigator. But they, if they find that hole in your fence or that miss signature and pull that thread usually, I mean, no company is perfect.
They're likely to find something and there may be a finding. And so, there was something that you said that made me think of what was it?
Maybe it'll come to me a little bit later, but. Yeah, it's just. You started bringing back some different memories, I guess in my mind. Oh, it was the ability to get a hold of people.
You'd think it'd be easier in real life.
And as you were talking, I had forgotten all about this. But booking a conference room was such a pain. Yeah, I might. I need a Decision made today. But I can't get everybody in the same room because the conference room's booked out until next week.
So, we're not going to decide until next week because of the conference room availability.
So anyway, yeah, things have changed for sure.
Michaela Kivett: And, and I still do like meeting in person. I like having a whiteboard, but when it comes down to it, it's just so much faster to just hop on a zoom call with someone.
Etienne Nichols: Yeah. Okay, so, but I, I probably speaking to the, you know, maybe preaching to the choir, those out in the audience. If you're, if you're still in person, please know that we envy your face-to-face interaction. So, you know, it's two sides to every coin. But, but let's talk about implementing an eQMS.
Maybe let's start out. What is an eQMS versus a QMS? Do you have any thoughts or analogies? Love to hear whatever you got.
Michaela Kivett: Yeah. So, I will say we use the term eQMS a lot and I feel like most people that we interact with typically already have what is technically considered an electronic quality management system, which is just you have your files electronically.
I don't think I've met a single customer who truly has files in a binder in their office somewhere. Pretty much everyone's using something like SharePoint or Google Drive and maybe it's, you know, a paper electronic quality management system, however you want to call it, but it's just in a SharePoint or Google Drive.
And then you have something like Greenlight, which is a software that's actually developed for medical device companies to help you manage all of the processes that are managed under your quality management system.
So quality activities, design and risk.
And it's just another level of functionality that you might not get with SharePoint or Google Drive, but essentially any electronic way to manage your quality procedures would fall under the eQMS umbrella.
Etienne Nichols: Yeah. Yeah. And then kind of the analogy I've used in the past, curious what you think about this, is I look at the eQMS as the paper.
The QMS is the words on the paper. And so, whether that's digital or physical, you know, or a cabinet or whatever, it's how you store the actual words. The actual words are your procedures and everything else.
And that's your quality measurement, your approach to quality.
I don't know. I'm sure it could be refined. That's the thing I've thought about. But what are your. So, when it comes to switching from one thing to another, because maybe before we talk about switching, let's talk about just the different options people have. I mean, we've talked a little bit about paper, we've talked a little bit about some of the pains, but we haven't really laid out the different things or different options people have at their disposal.
Do you, do you want to take a stab at that? And I'm happy to throw mine out there.
Michaela Kivett: Yeah, absolutely. So, I say that what people probably start out with, if, if you're creating a company from scratch, creating a product from scratch is something just like an electronic repository like SharePoint or Google Drive.
It's simple to get into. You can just start creating your files right away. I see that very commonly with startups. So just people who have a great idea about a medical device and want to start the development process and it's easy, you can just create a Google Drive and start putting your documents in there.
And then typically once they, once they reach a point, they realize that there's a lot more to getting a device on the market and keeping it on the market. And there maybe is a little bit of a knowledge gap if they don't come from a regulatory background.
So, they start reaching out, looking for other solutions like Greenlight that have some of the regulatory aspects built in, that SharePoint or Google Drive could never replicate and probably would never replicate because they're not medical device focused.
Etienne Nichols: So, we've got. Okay, and if we go maybe even upstream of that, let's say two guys in a garage or something, they're tinkering or whatever, they've got their stuff on paper probably, but maybe not.
I don't know. At this point, I don't know if anybody's really putting anything in a file cabinet. You're probably right.
Maybe don't. I don't know. Well, anyway, so what's crazy? I mean, I just go back to my past and I remember, I just remember there was a vault where you literally had somebody with a key to let you in that control.
You had to talk to Dot Control if you wanted those certain DHRs, and I throw me crazy when they went on vacation. But as a manufacturing engineer, so you've got the paper, you've got the SharePoint Google Drive.
I guess I look at maybe the very generic Oracles and Agiles out there that are kind of built for anybody in steel industry airspace. And then you've got more specific things like Greenlight Guru and others.
Michaela Kivett: Yeah, absolutely.
Etienne Nichols: The one thing that I think is, and you know, different companies at different sizes, you've used, you've worked with all of the different ones. So, I mean, they may have different pain points at different points in their journey to, you know, medical device development or selling, commercialization, whatever you want to call it.
What are some things that you feel like are very, I guess through lines when it comes to the medical device industry and why, what the benefits are of having an eQMS that's specific to MedTech?
Michaela Kivett: Yeah, absolutely.
I'm going to say the most common pain point that I see, regardless of company size, is organization and ease of finding your files.
And that sounds very simple. And if you were to just start a company today, you might think it's very simple to manage everything in Google Drive or SharePoint.
But I think a lot of times you underestimate exactly how many different documents and records you're going to be producing and how many different places they tie into each other.
So oftentimes I hear customers talking about, well, we're managing everything on SharePoint right now, but it's really disorganized.
We're having a hard time keeping track of all the events. We're having a hard time putting our design and development file together and we want something that's integrated that will build these files to out for us.
Or it could be a very, very large company who thinks they already have a lot of that organization in place and they're saying, you know, it's taking us a really long time to close quality events or we're having to track people down for training. And it might sound like a different issue, but at the core of it, they're still doing a lot of tedious work of tracking people down and notifying them of a task that come that comes up or what document do they need to look at.
And so having something like Greenlight and I'm thinking about our quality workspaces where you can build in automations that reflect your procedures. So that if I open a supplier audit, all of my tasks are generated for me and they can link to all of my different supplier forms and procedures and work instructions so I don't have to go and gather files myself and I can set it to automatically be assigned to someone so the burden of all that administrative work goes away.
So just organization is the most common pain point. And it's a very simple pain point. I think every industry probably feels that.
Etienne Nichols: I think that's a really good illustration.
Many moons ago I was in Intro to Engineering. It was so great because the first thing they had us do was build a Rube Goldberg project. And if you're not familiar with the Rube Goldberg project.
They basically say, okay, we want you to put some work into this system.
And the system, I use that to very loosely. And you can use any of the simple machines that are out there. So, I was a mechanical engineer. So, the simple machines were like the wheel and axle, the lever, the inclined plane.
You know, something could slide off, something. You had the pulley system, a screw and a wedge, something that would.
I think that's all of them. That's all I can remember. But anyway, so you had all these simple machines, and you built a Rube Goldberg project, meaning you want. You know, usually you had a mousetrap that would shoot something over, and then something would fall off the table.
It would hit a bowling ball, it would roll, and it knocked something over, and that would knock something else over. And eventually it popped the toaster out of the toaster oven or whatever you're probably thinking, what are you talking about?
Okay, let me transition back over to MedTech. So, we got MedTech, we got audit management, supplier management, risk management, CAPA management. All of the simple machines of MedTech.
And most companies look like a Rube Goldberg project if you actually look at their processes. They've got spreadsheet over here with a Word document over here, and they've got this over here.
And then to me, when I Look at the eQMs, it's turning all of that into an actual toaster. You no longer have something strewn across your whole lawn. You have it all in one place with all the settings and features that you need.
So that's the benefit. I see. And no one followed that. I am so sorry.
Go ahead.
Michaela Kivett: Let me. Let me paraphrase. It's just having everything in one place, so you don't have to spend time searching through your SharePoint or worse, your Outlook or your Gmail to find.
Etienne Nichols: Yeah.
And, you know, if anybody's ever actually done a Rube Goldberg, you know that it is not a robust system. It might actually accomplish the job. But if one little thing's off, the whole chain is broken.
And so no very little redundancy in that side. Typically, you know, intro to engineering students. It is what it is anyway. So, yeah, that illustration off the table, people could take that or leave it.
We talked about what it is, and, you know, I think in our intro, we were going to talk about the what, the why, when, how, who and how. We talked about what. We talked a little bit about why, I think.
I don't know if there's anything you want to add about why you might need a system to manage your quality management system.
Michaela Kivett: Yeah, the why differs for every single customer. And I think the why and the when kind of typically every customer is coming to us with some sort of pain point. And it's typically when the pain of their current process is unmanageable.
It could be that they are Preparing for a 510(k) submission and want something that'll help them along the way, or it could be that their executive management has set a goal of we need to close quality events quicker.
And it's just typically when your current processes are too much for you to manage and that happens at different places for different companies.
And I, I do want to say you, you can do a lot in SharePoint, you can do a lot in Google Drive, but there does come a time for everyone that it's just not efficient enough or effective.
Etienne Nichols: Right.
You know, I have, I have this thing that, this phrase that I use or maybe just illustration. I'm full of illustrations today. I'm so sorry. I'm just now drinking my coffee for the first time and it's in a pink cup.
I'm not sure why, but anyway, it doesn’t matter.
Okay.
Every medical device company is kind of like a stool with three legs. Three legs being the ethics.
Would you actually use this device on your mom or your son or your family member? So that's an ethical consideration.
There's a legal consideration.
Would you actually.
Are you adhering to the regulations? So that's legal. I mean, code of federal regulations, that's a federal thing.
And then the third thing though is monetary, economic. Are you actually driving value? Because money is the air that companies breathe. They kind of have to make a profit, otherwise they're not going to be around much longer.
So those three things are very important. And when we talk about why you might need something like this organization makes sense, efficiency, all those make sense from a company standpoint. Companies want to be valued higher and higher every time. You know, we want to get to, you know, venture capital, we want to get to private equity, we want to get to merger and acquisition or maybe an IPO. All of these milestones along the way.
The more mature you can be as a company, the more set up you're going to be for that next milestone. And so actually having organized processes is a way to show that maturity.
And not only just show maturity from like a, hey, look at us on a standpoint, but to actually be mature.
It feeds every other process so that now you work more efficiently, you work better, better as an organization, you attract better talent. I have lots of different reasons why I would use something like that versus a scattered system.
You come into a scattered system, people are like, what is, is this even a real company?
You know, it's, there's, there's reasons to do some of those things beyond just the, the basic efficiency things. I think so.
Michaela Kivett: Absolutely.
And like you said, there's the, you know, why are we making this device? The humanitarian part of it, there's the legal and there's the monetary.
There's a lot of product development work that happens before you see any profit. So the quicker you can get through it, the sooner you can start seeing a return on investment.
Etienne Nichols: Right.
So, those, a lot of the W's that we covered, I think we really need to hit the maybe the who and the how.
So, who are we talking to? I feel like I should have started with this one, but who are we talking to and how can they actually accomplish this golden state that we're kind of describing?
Michaela Kivett: Yeah. So, the who that I talk to, it usually is a lot of people, but it's typically your quality manager or your quality system manager could be your doc control.
And then maybe a little bit later in the process, they'll bring in some of the product development engineers. When we're talking about maybe design risk, but it's usually your quality manager, your lead QE that we talk to the most.
Etienne Nichols: Yeah.
And when we talk about implementing a quality management system or an eQMS should say an electronic quality management system, we want to implement something efficiently, obviously, without disturbing the company's, you know, goings on and, and, and their existing efficiency. I think that, that, that step jump in we are here, there's going to be a natural if you graft out the efficiency.
All right, I'll try to do it mirrored here to right to left for me, but left to right for you, you're going along at your current efficiency state, there's going to be a dip while you transition, I would assume. And you want to just mitigate that area under the curve as much as possible before you have that rise in efficiency, because now you're using a more efficient tool.
How do you navigate that step jump in such a way that companies don't regret their decision?
Michaela Kivett: Absolutely. And like you said, it's always good to note that in the, in between there, there might be some, some slower progress.
But I like to think about it as if you're moving a house because when we think about electronic files, we typically think it's pretty easy to just send everything over.
But you want to be mindful and thoughtful about how you're organizing the new system, so you don't end up with just a massive pile of files. So, the first step for me is always doing a self-evaluation of what documentation do you have, what procedures do you have, what training do you currently do?
Take a look at your training matrix, get a very good understanding of where you're at, and then create a thoughtful plan to migrate everything over, focusing first on getting all of your procedures up and running and starting training.
And then you can start to focus on design, development and quality.
So, taking it basically one room at a time, but making sure that you're essentially packing up the rooms in a way that makes sense to actually move it over instead of just dragging and dropping all of your files.
Because there's, there's obviously a pain point about your current system.
And I, I think having a dedicated medical device eQMS solves a lot of pain points, but it's, it's not a magic wand. If you're having issues with organization currently, just moving it over in the same way won't solve all of your issues. So, you, you have to truly think about, you know, what, what's the real problem? What's, you know, what are we trying to solve?
Etienne Nichols: Yeah, that's a really good analogy. Maybe we could go further into this because you're thinking about, like, when I think about, I'm moving from this house, there may be different reasons why my family's grown, you know, we have more fam people, which means we need bathrooms in different places, you know, and we're starting to cook more.
We want a certain flow in the kitchen. All of those things are going to matter when we're shopping for the house. What else? Any other things to think about?
Michaela Kivett: Absolutely.
Thinking. You know, you brought up a good point. Oftentimes we see customers decide to choose the eQMS because they've gone through a merger and they want everyone to have the same platform.
So it could be that you need to do an internal audit of all of your procedures because they don't align anymore.
It could be, like you said, that you've outgrown your house. Maybe you've been keeping on too many records in your active production area, and you need to have some sort of legacy storage.
If you have 20 years of supplier audit history that's clogging up your workspace, maybe you need to package that in a different way.
So, there are definitely a lot of considerations, especially for our larger customers who have a lot of legacy information. And for smaller customers, it's more about thinking ahead. So maybe they're buying a bigger house because they think they're expecting a kid or they want to grow their family.
So, putting the plans in place, knowing that your company is going to expand, I think is the best way to do it, to plan for the future.
But there's lots of opportunity.
If you plan for the future and you set up your training in a really good way, you could essentially make it so that you're training manager never has to track someone down to complete a training.
Which, which would be.
Etienne Nichols: Yeah, yeah, I remember Kathy was the one who would always track me down. Not that I. Okay, yeah, I was typically.
Anyway. So yes, I can totally see where you come from. And I love the analogy to torture the metaphor just a little bit more. I might suggest that if you are in a house.
Okay, let's just be honest, not everybody is perfectly immaculate.
Even your, your best state. There, there's a, there's a certain amount of entropy living in a house. You know, I hate to say if your jeans are on the floor, whatever else the thing is, and you call someone in to pack it up and move, you probably don't want everything exactly as cluttered and messy as it is now.
Pick it up. Exactly. It is. And put it in this new house. Exactly. Messy the way you don't want that. You want, you want, you want everything where it goes so that you start out with a fresh, clean slate.
Things looking nice, right?
Michaela Kivett: Yeah, absolutely. And that's a lot of my job. And what I do with customers is they'll come to me and say, okay, we want to migrate over all of our procedures and all of our records.
And we'll sit and we'll have a conversation and they'll start saying, actually, let's pause. I want to take a closer look at this because these are a lot of records and we don't even use them anymore. Or you know what, actually, I think we're missing some documents here.
So, it's really just an opportunity for improvement. You're not just getting a new software, you're doing an internal audit of yourself at all levels of your QMS. And you're going to find lots of room for improvement.
And it might not just be implementing the software; it could be updating your training matrix to cover areas that you found that you've lapsed.
Etienne Nichols: Yeah, and I think there's. Yeah, there's so many different things and reasons to improve your, your processes, even change control. Maybe your change management system is currently set up in a certain way because of the, you know, constraints of SharePoint or Google Drive. But now you have the ability to implement certain questionnaires and things as you go through the change management.
So maybe you don't need multiple stages that you previously need. I don't know. I'm just kind of thinking some different things here. But so, what are some other tools that can help this?
Because I can see, I can totally see this being a feeling like an insurmountable task. If I'm listening to us talk or whatever and I'm thinking, okay, we've got 40 procedures, you expect me to go through every single one line by line and figure out what might need to change just because I'm moving to this electronic system, that's that. That seems like a big.
Why would I do that? Because that's a ton of work for myself.
Any thoughts or tools or ways to mitigate that work?
Michaela Kivett: Absolutely.
So, if companies are open to it, there's plenty you can do with AI to help you scan through your documents and find potential deficiencies. With ISO 1345, that's an easy way to do a self-audit of your documentation and have it spit back some problem areas for you.
Even then you could just simply pull ISO 1345 audit prep table and kickstart your review. That way you absolutely don't have to start from scratch.
So, AI is a great tool and even just having it, you know, suggest categories of documents, if you have all of your records in one single folder, if you have a thousand of it, can read through the title and say, okay, these are the three groups you need to create.
Yeah, at least seeing customers, customers do that.
Etienne Nichols: I'm very compartmentalized in my thinking. So, I can totally see the industry side, the actual MedTech side, and maybe even say, I'm going to go with three categories and you tell me if this is too many or too little, maybe there's more, but there's a category of information related to your actual product and maybe your region,
you know, all the different indications for use and so on. So, if you have this product code, you have all these expectations, you know, you could do an audit that way.
There's the regulatory side of just your medical device. So, you have ISO 1345-14-9716230-4623, whatever it is, 6601, all the different soups that you could throw at it so that you could audit it that way.
But then the one that I'm really interested in too is changing up Your processes around documentation, record management, et cetera, quality management.
I was in SharePoint, now I'm a Greenlight Guru.
There's a workflow difference. You know, used to we did it this way, now we're going to be doing it this way. Where does everything need to change? I'm hoping it's only our document management procedure, but maybe it's our design controls and risk management as well.
You know, a lot of things could change now how we do these different things. Things.
That's an area that AI could help as well.
What do you think about that?
Michaela Kivett: Absolutely. And you could even just search for a keyword if you mentioned SharePoint by name or if you mention the file system.
Yeah, you. And just a more robust way than doing control.
Etienne Nichols: Yeah.
Awesome. What other pieces of advice do you have?
Or just things that you've seen that the most successful customers, most successful adopters of an eQMS just kind of like the different pieces of criteria that you say, okay, I know this person's going to be successful because X, Y, Z, what are those?
Michaela Kivett: I think it, it goes back to a culture of quality and realizing that when you move to a new eQMS, whether you're moving from paper to SharePoint, SharePoint to Greenlight, it's more than just learning the platform. It's truly an entire system overhaul into give yourself grace to realize that, okay, there are some room, there's some room for improvement and we're going to improve it while we're going through this process.
So, it's not just about learning, you know, what to click, it's about realizing, okay, the way we've been training our users right now doesn't make a lot of sense.
I've learned how to train my users in the Greenlight platform, but let's actually update our training matrix so that it works out better for us. Because you can transfer your training matrix over into Greenlight and the system will function, function as intended.
But if you haven't trained your users or set the system up properly based on your training matrix, it's, it's still not going to work. Right. So, there's a lot of self-reflection that needs to happen.
So, customers who come to me and say, actually we currently hate our training matrix, can you take a look at it and tell us what you think? And I say, yeah, it looks like every single user in your company has a different set of training requirements. I'm sure that would be hard to manage just being, you know, open for opportunities for improvement besides just learning a new software.
Etienne Nichols: Yeah, yeah. It's almost like how to slice that data where. How can we group things? How can we just, you know, do typical efficiency maneuvers so that you can start automating things?
That's. That's good.
So, there's two things you can use. Oh, go ahead. No, you go ahead.
Michaela Kivett: Just, at the end of the day, it should make your life easier. So, if you, if you don't feel like it's making your life easier, you need to take a deeper look.
Etienne Nichols: Yeah. And so, one of the things that I'll just kind of throw out to anyone who's listening is.
So, we have mentioned a couple things that can help if you have any kind of intimidation about moving from this to that, or if you're interested in utilizing Greenlight Guru, but you're a little intimidated by moving over.
AI is one tool, artificial intelligence.
But there's also something at Greenlight Guru, we have another type of AI that can help you, and that's someone like Michaela or any one of our medical device consultants. And they are actual intelligence.
Because you've seen so many different companies. I remember when I was working on the, at the time we called ourselves medical device gurus, the customer success team. I worked with about 40 different companies.
But, yeah, you started to see patterns. People who did this, you're going to struggle.
I know 30 other companies who have done it this other way, and it's so much easier, so much more efficient.
And you being able to see that across companies can be incredibly helpful to share.
Michaela Kivett: Yeah, absolutely. And I will say, you know, we have professional services, so I manage the document migration program for our larger customers. So, we can actually help you migrate your files over.
We can help you set up your training requirements. And that's usually where I see the most dialogue and the trickiest transfer, because most customers do have some issue with how they currently train their users.
We can help you migrate over your design and risk projects. So, there's a lot we can do from our side to give you, you know, our professional feedback on ways you can improve and to help you set your system.
Etienne Nichols: Yeah, we've talked a lot about Greenlight Guru from a quality management system perspective, because eQMS is one of the main things that we do. But I don't want to leave our clinical trial solutions out either.
And that may not be your expertise. So, I'm not asking you to comment necessarily if you don't want to but feel free if you do. But if you have electronic data capture needs where you have a clinical trial coming up very similar pain points, a lot of similar things. But what we have is that EDC software solution that helps you maintain 14155 and all the other different requirements that medical devices require when it comes to performing those clinical trials across multiple sites, across multiple regions and just to do all of those different patient reporting requirements.
So, I don't know if you want to comment on that, feel free to punt, no big deal either way.
Michaela Kivett: I'll punt it a little because we do have dedicated gurus over on the clinical side who have a lot more expertise in the clinical area than I do. But when I talk to customers who are going through clinical trials, I've heard some dialogue that they're currently using, you know, contract researchers to help them with their clinical trials and they, they want to look at options for the company to manage clinical trials themselves. So, they've been interested in the form builder, in ways that they can take ownership of that process rather than just outsourcing it.
So, the clinical side is a, is a great opportunity for customers who are in that realm to own more of their product development.
Etienne Nichols: Yeah, and I'll just say the same thing I said for that. So you mentioned the gurus on that side of the house. So, we have the AI that can help you, the artificial intelligence, but we also have the actual intelligence people who've actually seen so many clinical trials dating over the last 10 years.
So really cool.
Any other last piece of advice for anyone out there looking at this, wondering about implementation, thinking about this?
Michaela Kivett: My only piece of advice is, you know, there's a lot you can do with SharePoint and Google, but at some point, you're going to find that there is a better way to do things and take a look around and see what functionality is out there. Greenlight has a lot of really great functionality that I certainly would have loved when I was a quality engineer.
So, you know, you can always, you can always look sooner than you think you're ready. So, for some of our smaller pre-market customers, there's always room to grow into your system if you choose. You know, we have some customers who are only two or three people but are future thinking and know that they're going to grow into a big company and want to set things up from the start.
So, it's never too early to look and see what's out there.
Etienne Nichols: The only thing I would add on to that is when you're evaluating different options and thinking about functionality.
The other thing I would think about is the partnership aspect. How much of a partner can they be how much of an almost an outsourced employee can they be? So, you know my background, I was, I was a manufacturing engineer, then I was a product development engineer, got my PMP, became a project management for a product development project. It was a drug delivery combination product and so I really loved using Microsoft Project. I've since used asana Monday.com and I'm resistant to change and it's terrible.
My team would just tell you they just want to hit me over the head with a two by four sometimes, I think. But I learned to value the customer support side of things.
I've very much learned to value that. So even with my background in project management, if I'm using a tool where I can say, man, okay, I want to know how other teams do this and just hit them up and they say, you know what, if you rearrange it like this, everybody's going to be able to see it this way the perspective is going to be better. You're actually going to utilize it.
I'm so thankful for that. So, I just throw that out there. Consider that as an option or one of the pieces of criteria when you're evaluating different solutions.
Michaela Kivett: So yeah.
Etienne Nichols: All right. Thank you for putting up all my rants, Michaela. I don't know why I do this sometimes.
Michaela Kivett: No, it's lovely. I always love your, your rant and your examples.
Etienne Nichols: Well, thanks so much for being willing to come on to the show. Thank you. So, I know you're so busy. Sometimes your, your schedule is packed back from the day you start, from the moment you start to the time you sign off, you have back-to-back meetings.
And so, I really appreciate you carving out some time for us.
Those of you listening really appreciate you hanging in there with us. If you have any questions or thoughts, feel free to reach out to Michaela or myself or anyone on our team.
Happy to direct you to the appropriate avenues and we'll do what we can to help. But until next time, everybody take care. We will see you next time.
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