Implementing an eQMS after Switching from Paper

February 1, 2023 ░░░░░░

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What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch.

In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at Greenlight Guru. When it comes to implementing an eQMS - Kendyl has experienced the sales process and has also implemented it for her company, and now she works with companies to help them implement the new software as well.

Listen to the episode to hear what Kendyl has to say about the pain points of a paper-based QMS that leads companies to make the switch to an eQMS, challenges at the beginning of the switch, and a realistic timeline for implementing the new system.

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Some of the highlights of this episode include:

  • The pain points of a paper-based QMS

  • The effectiveness of document-signing parties

  • What the implementation of the eQMS was like

  • What isn’t validated out of the box

  • Complaints or challenges in the beginning

  • How to ensure traceability between risk and design controls

  • What to do with the physical documents after switching to eQMS

  • A realistic timeline from purchase to implementation

Links:

Kendyl Williams LinkedIn

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Kendyl Williams:

“I know Greenlight has definitely changed a lot since we used it last, and I love all the new features that have come out because I think they really help to set people up for success when getting into Greenlight.”

“I think my team struggled initially with the nomenclature of documents.”

“The sandbox is also just a fun place to poke around.”

“What I usually tell people building an eQMS is to be intentional in your setup.”

 

Transcript:

Etienne Nichols: Hey everyone. Welcome back. It's, it's good to be back with everybody. Today I'm talking with Kendyl Williams. Kendyl, how are you doing today?

 

Kendyl Williams: Pretty good.

 

Etienne Nichols: So, we already talked a little bit before this. Neither one of us have talked much today, so forgive us if our voices aren't perfect. But anyway, yeah, I'm excited to be talking to Kendyl.

 

Kendyl is one of our medical device gurus here at Greenlight Guru and she's also been through the implementation of of eQMS, going from paper based to eQMS. So really want to dive into that.

 

But first of all, Kendyl, do you want to just maybe give a little bit of your background and some of your experience?

 

Kendyl Williams: Yeah. So, I'm Kendyl Williams. I have a little over five years of experience in medical device. I've worked anywhere from new product development and R and D to more quality engineering facing roles.

 

I've worked with MDR. My favorite things to work with are risk and design controls.

 

I really enjoyed doing that and I've just bought every project I've ever touched. Since those are documents that never quite go away, they're definitely living documents and it's never a one and done situation.

 

So those are my favorite things to work with.

 

Etienne Nichols: Well, someone who really likes design controls and risk I would say is pretty valuable in any organization especially you know, Greenlight Guru. That's you know, to me when I looked at the software of Greenlight Guru, the design controls is what sold me on the software itself.

 

It was so cool. But okay, but I want to talk a little bit about your, your experience implementing an eQMS or going from paper based. And maybe that's where we should start.

 

Why?

 

What are the pains of paper in your mind of having a paper based QMS?

 

Kendyl Williams: So, for my team when we were paper based, we traveled a lot to conferences or people were at different sites at different plants. It was sometimes hard to get, you know, locate people even if they were in the same building. Were they in the one of the labs, were they at their desk, were they working somewhere else?

 

So literally chasing people down and by chasing I do mean chasing sometimes to get them to sign a document, to review a document could be very difficult as well as once that document was signed then we'd have to make sure it got into the appropriate binder and the fireproof cabinets we had, and then later on trying to dig through. I spent a lot of my days sitting. Sitting on the floor in front of the fireproof cabinets, just grabbing binders and guessing about where everything was, because we had a really good system.

 

But if you don't quite know what you're looking for, sometimes that can make it difficult to know where to start to even locate the document you're trying to find after the fact.

 

So, my big thing was just. It was hard to even just get signatures, which is one of the most important parts of documentation.

 

Etienne Nichols: Yeah.

 

In my past, I can remember the logistical side being one of the most difficult. For example, I just.

 

You kind of made me think of something like when I was going through those cabinets, I might think, well, this is a record. It should be under this, you know, heading, but maybe it's over here under this other heading, so.

 

And it can't exist in two places because it's a physical document. Right. And.

 

Yeah, that's. That's a really good point. The other thing you mentioned is chasing someone down. I'm curious if you have any specifics about that, but I'll let you decide whether or not you want to talk about that.

 

But I remember one time in my history, too, where I, I. It was a VP. I would put it on his desk, and I'd come back in a day or two, and he'd be like, oh, man, I know it's here somewhere.

 

And we couldn't find it. I'd have to go back and reprint it, and have it recirculated until it got to him again. It killed me. But I'm curious about your chasing people down.

 

Do you have any specific stories?

 

Kendyl Williams: Yeah, so we actually, after, like I said, it was hard to pinpoint people just because we were all over the place.

 

We used to have what we call document signing parties. So, it would have to be a meeting. And sometimes my team worked well with food, so, you know, we'd have to encourage people to bring snacks, make it fun, and then just. All right; here are all the documents you need to review and sign.

 

Because it, it just, it really was truly trying to. All right, well, where is so and so today? Oh, they're at a. They're in North Carolina in the plant. We worked in South Carolina.

 

So, it was just. It could have been difficult to, you know, even just figure out where everyone was. You couldn't just. And if they're in a plant, a lot of times people aren't checking their phones, so it's Like, I need to be, I need this document signed now.

 

We need to get this through pretty quickly, especially if it was like a deviation or something we needed to do.

 

So just trying to locate those people and then actually get them to review and sign. And then if we were traveling, that was a whole other thing. Like, oh, things are delayed all week because we're at conferences, someone's on vacation or someone's just out sick.

 

Like, it could definitely get pretty tricky.

 

Etienne Nichols: The, the document party or document signing party.

 

I, I had forgotten all about that sort of thing, but I remember us saying we need a document signing party.

 

What is your experience as far as the effectiveness of the review and so forth when it's a document signing party? Do you know. Do you know what I'm saying?

 

Kendyl Williams: Yeah. So, it was usually pretty good. I mean, we usually had a pretty good turnout because people were encouraged. If not, I won't use the word forced, but we. It was pretty much a mandatory thing.

 

It did take it. Sometimes it could be hard to find a time during the day. You know, all of us, we were just all over the place and we all had different projects we were working on.

 

So just finding a time to do it could be difficult. But once we did get everyone in the same room, it was relatively effective. You know, all right, sign and pass.

 

After reading it, of course, and making sure everything looks good, but definitely did take up more bandwidth that as a smaller team we might not necessarily have had at the time.

 

Etienne Nichols: Was the room really quiet while they would read and then pass? I, I'm. Everybody has. Does it a little differently. I'm curious how it actually worked in the room if, if you don't mind sharing.

 

Kendyl Williams: Yeah, so we were a pretty close team. So, it would be if, you know, we were in the weeds reading or if we were asking questions or something, you know, we would talk.

 

But we were pretty, pretty close team. So, I don't know if any of our meetings were ever particularly quiet.

 

Etienne Nichols: Yeah, that makes sense.

 

Okay, so you went through these different experiences, but then what. What was the catalyst to move from a paper based to an eQMS? I mean, I know a lot of companies, maybe they experience that, but they're like, well, you know, I mean, it's what we've always done.

 

We're just going to keep doing it this way. What actually forced you guys to change?

 

Kendyl Williams: So, we had been thinking about it for a while and looked through a couple companies.

 

We actually went to a conference in New Jersey, and we met Greenlight Guru. So, we met David Dram and some of the other sales reps, and we just started talking to them and kind of what our needs were, what we were looking for in any QMS.

 

And, and I think it took a couple months of convincing, you know, the rest of the team to get the buy ins. And so sometimes people are more comfortable, like, oh, the paper based. It works. Technically. I was like, well, it works, but I'm all about process improvement.

 

So, let's see if we can get this, you know, a little bit easier. But after many conversations with Greenlight and then with some of the senior leadership, like, we need this.

 

This is our use case. Look how easy it is to do this. We. It's. There's not a whole lot of heavy lifting to set up the system since it is kind of a plug and with some customizations you can make to tailor to your own team.

 

But that, that was just kind of. We'd been wanting one for a while after.

 

I think we might have had one too many signing parties or just people.

 

As we started having more locations, people were more dispersed, and it just really was a necessity at that point.

 

Etienne Nichols: Yeah. So how many people went up? Was, was it a conference in New Jersey? Mm, okay.

 

Kendyl Williams: So, it was. Yeah. Three people from my team, including our quality manager who turned into our director or QARA, and then myself and then one of my other associates who now works at Greenlight as well.

 

Etienne Nichols: Cool.

 

So how did it go once you, once you got past the, you know, the negotiation and making everybody buy in and so forth, what was the imp. The actual implementation like?

 

Wow, I can't, I really can't talk today. Go ahead.

 

Kendyl Williams: So, the way that we did it is we were like, we want this implemented as soon as possible. So, there was a team of three of us who kind of just.

 

We divided and conquered. And so, I handled a lot of the. Getting the design control matrix put into Greenlight in the projects’ workspace. We had people who are more dedicated to procedures, and we actually ended up renaming everything, so we didn't like our old numbering system.

 

So, when you're moving quality systems, it is a good time to kind of clean up things that aren't working for the team anymore or we're not really sure why that we chose this numbering system or someone else chose it and we just don't like it anymore.

 

So, we use it as a really good time to clean up a lot of stuff within our system as well.

 

And then I think to validate Greenlight Guru, when my customers, when I talk to them about, you know, the best way to do it. I was like, we honestly went to a coffee shop, locked ourselves in there, validated it. You know, we had to go get away from like, we're going to do this. We did it in, I think a morning or an afternoon.

 

And then we just drew lines in the sand for. All right, all projects going forward are going to be using Greenlight Guru. We did have a lot of legacy documentation.

 

So, we kind of made a plan for what is and what is not going into Greenlight at this time, just due to bandwidth issues.

 

And then we trained the appropriate personnel. And a lot of what went into that was really just figuring out the why.

 

What, like, what people were looking at, what they wanted from the system. Cause some of our colleagues were more just like, hey, just show me how to do it. You know, we don't need to get in the weeds.

 

And then some of others were more interested in, okay, well, tell me more. I, I, you know, I really want to know the why behind you're doing this. So, we would just do training sessions internally.

 

We worked very closely with Greenlight as well, just to like, hey, we are completely lost and we don't know what we're doing with this particular workspace or this action.

 

So, it was a definitely a, you know, phone a friend trying to figure out what we actually needed to do. But we did it relatively quickly. And it, we got people used to it. And to my knowledge, everything's still going well.

 

I know Greenlight has definitely changed a lot since we used it last. And I love all of the new features that have come out. Cause I think they really help to set people up for success.

 

When getting into Greenlight, you mentioned something.

 

Etienne Nichols: So, when you were talking about going to the coffee shop and validating it, know, Greenlight Guru says they're validated out of the box. But what, so what is that involved? And maybe what's the difference in something that might not be validated out of the box?

 

Kendyl Williams: So, we do. And I spoke of validation, more like the IQ and getting everything set up in the production account and just doing like, all right, this all looks good. But since Greenlight is not, I believe the word we use is it's not configurable.

 

There's not a whole lot of things for us to go in and set ourselves.

 

So, the great thing was Greenlight has gone ahead and done all of like, the really heavy lifting with. If I click this button, does this work? If I do this, like, you know, random use case, does it everything work as intended? So that was really nice. That we just had a minimal lift on our end to try to get to being able to use it and saying, all right, we've checked it out for ourselves, we verified that, you know, what was presented to us in the validation package looks good and then here's our plan going forward.

 

So, I think that actually was a major selling point for us as well over some other systems was that we didn't have the desire or necessarily the time to customize everything and we didn't need that.

 

Greenlight had everything that we needed already built into the system.

 

Etienne Nichols: Yeah, when it's built off of 1, 3, 4, 85 and you know, know with part 820 in mind, obviously that, you know, you shouldn't need anything else. But you, you made a good point though too is when you lock yourself in the coffee shop, this is something everybody's going to have to do at some point, whether it's a coffee shop or somewhere else, is you have to go through that admin process and, and set up all of your user roles, the levels and things like that.

 

And that makes sense. And the actual validation, when you think IQ, OQPQ, the installation qualification, I'm being cloud based, it's, it's so minimal. But you, I, I don't think maybe some people don't realize that you do need that paperwork that came from Greenlight. You need to put it in a QMS for when you have an audit.

 

You can just bring it up and say, here it is, been validated. So yeah, no, that's cool. What are the things that. Did you hear any complaints? I'm, I'm just like. From your team, like, well, this. It would be easier if we did it this way than that way.

 

Did you experience anything like that? Just, just getting over some humps.

 

Kendyl Williams: I think my team struggled initially with nomenclature of documents. So, it was.

 

We all kind of had our way that we would title documents and then moving forward we tried to streamline that a little bit. So, if you had a test report, we're going to title it this way.

 

If you have, you know, some other type of document, we're going to follow this scheme just to make usability a little bit easier because that was really just. We all had our brains, worked a little bit differently for how we personally would like to find documents.

 

So that was kind of getting used to at first, but then I think we got it mainly figured out.

 

One of the other things was just documenting stuff when we were in the early phases. So, when we drew that line in the sand and we're starting a new project.

 

We're like, all right, we're going to create a new project in Greenlight, but how do we start, you know, using it for documenting this very early stages stuff? But we just took it slowly.

 

We used and I will say abused the sandbox quite a lot. I was in there all the time just running test cases, making sure we weren’t, or I was on the right path and wasn't doing anything incorrectly.

 

So, I think the sandbox is actually kind of a.

 

One of my favorite parts about Greenlight is it's a safe space to just do whatever you want.

 

Etienne Nichols: It blew my mind when I first, I guess, was working in the industry and whatever QMS that we had, I don't know remember exactly, I guess it doesn't matter. But anyway, there was one super user. We called him a super user. And as far as I know, in the entire building, he was the only one who knew how to use the sandbox of that, of that situation.

 

It was so clunky. I mean.

 

Yeah. Anyway, I don't want to bash on any other types of QMS necessarily or anything. I just was.

 

It just made me think of that as far as the sandbox being a place to. To play, it should be a place for everybody. Not maybe not necessarily everybody, but, you know, at least some people can get in there and do all those test things.

 

Kendyl Williams: Yeah. And this inbox is also just a fun place to poke around to see what people have because we never, when we were trying to teach ourselves to use this software, and this is what I recommend to my customers as well, is you don't necessarily have to build out a medical device, build out something fun in the projects workspace that you're really just getting used to using the system. You don't need to get in.

 

Like sometimes that can add a layer of complication if you're trying to like. Well, I don't know, a design input. For my specific device, I just chose one of my.

 

A product, a fictional product from one of my favorite TV shows that they had tried to market.

 

And I built a design control matrix and risk matrix built off of that with the intent of no one ever really seeing it. But it did get shown in a meeting once.

 

So that was humbling. But it helped me figure out how to use it.

 

Etienne Nichols: Yeah, you know what? It just. I've never. This analogy just popped into my head. So, I'm curious what you think of this. Some people think you, you know, build out.

 

Who was it? I think Laura Court, in our conversation she may have been talking about building out a burrito or something like that in your design controls matrix. Seems pretty silly, but it's almost as if you're isolating your variables to a certain degree.

 

You're taking out the technical 60601 requirements or whatever, all those different things, and you're just focusing on how user needs feed into the inputs and outputs and so forth and how they're verified and validated.

 

So. Yeah.

 

Kendyl Williams: Cool.

 

Etienne Nichols: What I'm. I'm curious, can I ask what. What was your design project?

 

Kendyl Williams: It was called Kitten Mittens from It's Always Sunny in Philadelphia. It's like, does your cat make too much noise walking around or my like user needs, like it needs to silence the cat.

 

And then some of my verifications and validations since in the real world we used healthy human studies, we would say healthy kitten studies. And so, I just like really laid into that and it really did help me figure out how to use the system and then taught me since I was still fairly new in my career.

 

It also helped me figure out appropriate user needs, design inputs, but without putting too much thought into it. It's literally like socks for putting on a cat. Nothing too crazy.

 

So that. That actually really helped me figure out the system and then try to figure out how to build out a project as well.

 

Etienne Nichols: So, before I forget about it. So, what was it like meeting David Duram?

 

Kendyl Williams: So, I.

 

I was still pretty early in my career. I was like, this is awesome. I mean, we went to. They're just such a good group that we went out with. It was David Jam; it was Connor believe Nick Tibman was there as well.

 

So, it was just a really fun group to kind of get to know. Cause you could tell they. It wasn't. It didn't feel like a sales process. It felt like a.

 

We really wanted to just help you all identify where we can help, you know what. What your needs are, what.

 

How our system can potentially fill in some of those pain points. So, it was really just. I had never had an experience like that. Right. And it was, it was just a really good time.

 

We were in. Like I said, we're in New Jersey and we.

 

I think we went out to New York with them, and it was just a really fun time just getting to know them and you could tell that they really believed in their product and were would just.

 

If, you know, we did end up pursuing that partnership. But it was. We knew it would be a beneficial one if we had chosen that route. And that was one of the main Selling points because it just really felt personalized.

 

Etienne Nichols: That's awesome. Yeah. He. All those guys you named, they're. They're just. Just seem like one of a kind. But yeah.

 

Kendyl Williams: Yeah.

 

Etienne Nichols: Okay, well, so you are a medical device guru now. Now, having worked on both sides, I'm curious what you.

 

Now that you work in the software, from the software company's point of view, what are some of the, I don't know, comments or things that people get really excited about or is any extreme emotion. I love to hear about those. Each one each, each direction. But yeah, yeah.

 

Kendyl Williams: So, it really depends on the customer. I have some customers too. If I just show them how to use, you know, attributes or just something what seems like minor, like some.

 

I know we have like a top 10 tips and tricks like the triple tapping the space bar thing. I know that like, just people are, oh my goodness, this is just amazing.

 

And then other customers just talking about like what, what we could do in the future. So, I have some customers who have some really good feedback about improvements they would like or, you know, just little things that would make usability a little bit easier.

 

So, I really enjoy those conversations as well. Cause I was like, I've used Greenlight before. I've been a medical device group. I never thought to do that. So, everyone just has really good ideas and then people are just excited to get into the system and not have to battle it out with Excel or Word or something to make their design control project or to make their risk matrix.

 

Because I know I have lost a lot of years off my life trying to merge cells or delete a row or just get something correct. It's just you, you move one thing and your whole document is like corrupted.

 

So that's one of my favorite features, and I think our customers like it as well, is the ability to build those matrices directly into the system.

 

Etienne Nichols: Yeah. And when we got on, we were going to talk a little bit about Risk, so we don't necessarily have to. We're maybe going to save that for a future episode or something.

 

But in your past, when Risk and Design Controls are in those Word or Excel documents, I'm curious how you.

 

And I'm, I'm saying this selfishly because when I was in charge of Design controls and Risk, two different documents, and trying to make sure that they married up, that they were traced to each other, that was, that was tough for me.

 

And I'm just curious what your experience was.

 

Kendyl Williams: Yeah, that is definitely my experience as well. Especially if you have a legacy Risk file that hasn't necessarily been touched in a while, or you have a design control matrix that was made by one team and then you know there are new teams working on it.

 

It can be difficult to figure out what was the justification behind this wording or what does this exactly mean as well as if you have similar projects or products, making sure there aren't any disparities between the two and just trying to, you know, make sure that everything matches between DHF or Tech File to Tech File. So that can be difficult. And I just feel like with Greenlight it's easier, at least for me just to actually see.

 

So, you can do a search that I feel like works a little bit better. You can use the tags, which is.

 

Makes filtering down a lot easier. If there's a way to do it in Excel or Word, I don't know what it is. So. And then just being able to structure things out with the components is easy as well as.

 

And then the direct linkage between the risk workspace and the projects workspace is awesome because you can do your sources and controls right in there without having to flip back and forth between your pages of paper and figure out, okay, well this, this is here and this one's there. What, what do I need to marry together to make my sources and controls?

 

Etienne Nichols: Yeah, and what.

 

So, when I came to Greenlight Guru, and maybe I'll ask the question first. So, you, you came to Greenlight Guru and now you're a medical device guru.

 

What was the thing that maybe sold you on it from a product perspective? Like, I know companies, usually when you come to a company, it's a, you know, maybe a person and, and different people that sell you on the role and things like that. But everybody I've met so far at least, you know, I, in, in our guru group, they really believe in the product.

 

And it's usually one aspect of the product that really stands like, man, this right here, this is how I'm going to help people's lives. And for me it was design controls.

 

But I'm curious how specific, however specific you want to get. What, what is the one thing you would say sold you on the, on the product?

 

Kendyl Williams: I would say probably design controls. I just think I, when I left my first company, I went to a different company that didn't use. We had an eQMS, but you didn't build anything within it. You still had to upload your Word documents in Excel.

 

I was like, man, I really miss being able to do this all-in-one place and just have it easily laid out in front of me as opposed to having to create a new one.

 

So, I'm a big fan of that workspace as well. Just projects in general.

 

But one thing that I learned about since getting to Greenlight is the addition of the attributes in the flexible document organization.

 

I think that just makes the usability of the system.

 

So, it's pretty easy. You know, I mean you can really easily create your views. You can get like with like and make sure you have all your documents organized correctly.

 

I am someone who on my computer I have folders nested within folders. I'm really into, you know, being able to know where to go to look for something. So, I think that's probably my second favorite feature that I learned about after joining was just the ability to apply those attributes and correctly organize your documents.

 

Etienne Nichols: Yeah. And if you're not using the Google tab, like grouping, like if you right, right click on a Google Tab or, or in Chrome and you're able to add it to a group, that's life changing as well. So, it's. I know that's not at all Greenlight guru related, but I want to just every time I talk to somebody, I'm like, make sure you're using those grouping it's native to, to Chrome.

 

So anyway, so any last pieces of advice that you feel you give customers repeatedly or you could, you could go back and give yourself when you're implementing a new QMS. Any, any pieces of advice that you would like to give just kind of in our, our parting.

 

Parting thoughts.

 

Kendyl Williams: Yeah. So, what I usually tell my customers is be intentional in your setup. So, I do have customers who will completely lay out their attributes, what they want to have, what they, what will go under which attribute, what classifications all different types of documents are getting. Because that just really helps standardize how things are laid out and make searchability a lot easier.

 

So, it's really just setting yourself up for success. Literally when you're getting into the system and you know it is plug and play, but there are things that you can do to make it easier on yourself down the road and just get people used to using the same naming conventions, the same tags or attributes, just triple checking before you add a tag. Because I know myself, I would go back a month later and be like, that is not how you spell that word.

 

So just being a little bit more intentional about how you're going about setting up your system. We did ours pretty quickly, but we had a very clearly defined plan so that worked out for us for the most part.

 

It's just when you have people who have different styles or different ways of doing things trying to proceduralize as much as you can. So that way there's one source of truth.

 

And this is how we are going to add these types of documents to the system. This is what they're going to be routed as. This is what attributes, you know, just really getting into the little things around the system that help usability down the road.

 

I think that's probably my best advice to customers.

 

Etienne Nichols: Yeah, no, that's really good because honestly, the more I realized, the more I worked with quality management systems, the more I realized it's kind of like a design project in and of itself.

 

You need to know what your needs are. You need to know, you know, what your,

the inputs should be so that you know your outputs. So, for things like that. But it's not a perfect analogy, but it's, it's, it's like a design project for sure.

 

Kendyl Williams: Absolutely.

 

Etienne Nichols: One, one other thing I wanted to, to ask is when you went from, let's see if I can remember this question. If you went from the paper based to the quality the, the eQMS, what about all of those documents, the physical documents? I think some people have a question of, well, what do we do with our old documents now that they're just sitting in file cabinets, now that they're in also in our QMS, Any, any recommendations there?

 

Kendyl Williams: So, for us, we, we didn't upload all of our DHFs nest our legacy DHFs. One of my coworkers, she was very proud of it, had made an 11-pound DHF. So that would have been a lot to put into the system.

 

So, we did retain some of our paper documents and then we just knew, you know, like I said, we drew that line in the sand. All right, this is a legacy product, so if we need to generate something for an audit, we can go back and get it.

 

But we also, I think we did decide to keep everything just, you know, didn't want to get rid just in case.

 

But our one source of truth for, you know, that date moving forward was green light. So, I know all of our DHFs and stuff. We still kept our procedures.

 

I, I personally wasn't in charge of, you know, disposing of anything, but those were most likely, you know, gotten rid of just because we didn't need them. We didn't want people to be, you know, snooping around and then accidentally find one and think it's the latest and greatest, but it's actually from like eight years ago.

 

So, what I would recommend to My customers is just have a plan and then be confident in that plan if asked by an auditor.

 

So, if you know exactly where the one source of truth is for a document, that's the best way to go about it.

 

Etienne Nichols: And so last question I'll ask, because you mentioned that you kind of implemented it, the QMS, quickly.

 

What was quickly in your mind and what's kind of realistic as far as from purchase to implementation?

 

Kendyl Williams: So, we implemented, I think the bulk of it. So, getting all of our legacy pursuit procedures into greenlight.

 

I want to say we did it in less than a quarter.

 

I'm trying to.

 

It was a couple years ago now, but I think we did it in less than a quarter. We really just went all in on everyone who had their assignments and just getting their respective pieces into greenlight.

 

I would suggest take your time. If that's not doable for your team, that's okay. Just make sure you have kept a pulse on what has been done, what needs to be done, and have a plan forward and then you can make decisions like my team did.

 

Well, hey, we're not going to upload the legacy DHS at this point.

 

At some point down the road, you can definitely scan and zip those documents and then, you know, upload them to greenlight. It just depends on what works best for your team.

 

But yeah, we did it pretty quickly. We were all pretty determined individuals and like, we want to use this. We are so tired of paper. So, I think we did it in less than a quarter, if I remember correctly.

 

Etienne Nichols: Awesome.

 

Well, Kendyl, thank you so much. This was really good. I enjoyed the conversation, and I hope that our audience will as well, but I'll let you get back to it.

 

Great talking to you today.

 

Kendyl Williams: Yeah, thanks for having me.

 

Etienne Nichols: All right, we'll see you later. Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform.

 

If you've got thoughts or questions, we'd love to hear from you. Email us at podcast@greenlight.guru.

 

Kendyl Williams: Email.

 

Etienne Nichols: Stay connected. For more insights into the future of MedTech innovation and if you're ready to take your product development to the next level, visit us at www.greenlight.guru until next time, keep innovating and improving the quality of life.

 

 


About the Global Medical Device Podcast:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...

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