The QMS conversation your clients are having without you

Hi, everyone. Welcome. I don't know why Fraz's screen's showing. The, Let's see. I'm gonna share my screen for a moment while we're warming up for today and waiting for everybody to join. Just ignore the number of tabs that I have open. And… hopefully… Go to…

The number of tabs is insane.

Sorry, I had this queued up, and then… Because I have too many tabs open. So, anyway, just to give you, an update, okay, here we are, I turned 60 on Sunday, so I want everybody to put Happy Birthday into the, into the chat, because if you don't, I'm gonna get my feelings hurt. And, being 60 now, I'm very delicate. And and get my feelings hurt more easily. I'm so kidding. But, please, please feel free to, drop a line on the post. In case you missed it yesterday, there was a super interesting session with, Albert Halusi from, Claramid on, real-world use research.

And for those of you who are unfamiliar with that term, it's because I made it up. The, term is a reference to market insights. Inhuman factors, and the barriers to actual usage of a device. That go far beyond, the usual conceptions. So, for example, you know, users just may prefer a competitor device, because it's easier to use. So they do head-to-head research, competitor research, with the two devices to understand, that sort of thing. So there's a whole bunch of nuances that go beyond what the human factors requirements are by the various bodies.

Next week, we are going to have the 7 Deadly Sins of Test Method Validation. With Simon, Foggere. And then, coming up in 2 weeks, a big 483 session, how to respond to 483s, what to do, what you need to know, everything you need to know about 483s. The 12th of June, we're gonna have In Silico Evidence with Suresh. Suresh from TubeSude. who is… So smart, it's scary. Doctor, lawyer, you name it, he's done it. And so yeah, and, in silico experts. And then on the fifth,

we are going to have… I'll get back to you on that. quick shout out to the International MedTech Safety Conference. Please, please join me in Boston. And… Remember to cast your vote. We've had over 3,500 votes so far. There have been some questions about, I nominated people, why aren't I seeing them on the list? Why aren't… why can't people vote for me now that I'm on the, been nominated? So I think the way to handle this is to take all of the nominations and do a second round of voting. In 2 weeks. So what we're gonna do is we're gonna take, like, the top 100 nominations.

and, then do, like, a runoff from that, or something. But at any rate, the nominated people should get as much attention as the… people who I picked. So, that is the update on that. Remember to check out MLVX.ai, and I want to turn it over to Leo for a moment to tell us what he's doing. On the 1st of June. per second.

So, I'm gonna steal the share if I can, Sean.

Yeah.

Okay, let's see. And I'm also going to be at the International Medical… MedTech, whatever, Safety Conference June 2nd through 5th, and talking on the 2nd and 3rd, so come join me, too. So you should be seeing, hopefully, my big screen that says IEC60601 4th Edition, and I'm going to be at… in Boston the whole week of June 1st. So on the 1st, I'm going to be in Boxboro at TUV Rhinland with, let me show them… Caitlin Brady. and Liz Casey, and they're both experts, and they're secretaries of their working groups, and we're going to talk all about 601 Fourth Edition. So I'm going to be talking about the overview.

and into a bunch of the working groups. They're going to be talking about physical environments working group for Caitlin, and for Liz, she's going to be talking specifically about mechanical hazards. Then. They all… we also, luckily, in Boston, have two other really super sharp ladies, Jenna and Ashley, who are also on some of the working groups, and so we're going to have an expert, Q&A panel. So I would call this the Women in STEM and Me, who serve the sidekick at this point, a Q&A session for an hour or more, depending how many questions we have. And it's virtual and face-to-face, so anyone around the world can join in.

And so… It is free.

Oh, okay.

So, I am gonna drop… I am gonna drop the link once I stop sharing.

Oh, right.

And… I can get there. just drop the link, and I will put… The seminar title in.

Alright. So, while you're doing that, I'm gonna move on, and I'm gonna introduce today's speaker, Charles Relay, from, TraceX, and TraceX is a service provider, in the med tech industry, with a, QMS platform. And he's got some really… a really interesting story to tell. Now, before we hop into that, I'd like to ask my favorite question of all of our speakers is, Charles, when you were a small child in France, did you dream of growing up To, have your own… QMS platform, software as a service, or… Or what did you want to be when you grew up?

Oh, certainly not. When I wasn't shy, probably not, so bad. I wanted to… yeah, I didn't even… know I was gonna work in software development, because even my studying, I studied, like, agricultural, engineering, which is weird. life sciences, you know, in general. So I got a master's degrees in there, so certainly not. Even before that, I didn't, I didn't plan to, To work, in the software industry, or, or in the quality management system, or in the platform for highly regulated industries. So, no, but I love it. I didn't, I didn't, I didn't know at the time, but now I love it.

So how did you get into it?

So, that's how I started to get pronouns Charles and old Charles. That's when I went to London. When I lived… so I'm from… I'm from France originally, and… and after… After studying my master's degree, I went to, I went to actually meet my girlfriend, who was from New Zealand. So we found a middle ground, which was London. Long story. Yeah, it was a shorter, shorter trip for me. And, and, and so, there I ended up, like, in a company, that there were… developing, like, a software for, pharmacovigilance. So, they were, like, senior guys from, not Justin & Johnson, the, the British one, okay, is gonna come back. But anywhere from a big pharma company, and then they decided from, to, to create, a software to simplify the pharmacovigilance processes. So I ended up

like that, and so I didn't know about software development, about, like, software in medical space, because it was not a medical device, it was a software for for, for medical, industry, but for pharmacovigilion, so it was following another regulation, close enough, let's say, for sort of development, but… but a different thing. So that's how I got… I got there.

So, we're here today to talk about the, QMS platform that you've developed, TraceX. Or tell us what it is. Tell us what TraceX is.

So… TrueSix is basically a tool that helps regulated companies to the… To do their day-to-day work, so soft… to develop their product. As well as preparing their technical file, I mean, the DHF, and their… to pass, the audit. Because what I've been… when I was in London, or then when I worked in France in medical device companies, so… You have this kind of… Separation between the regulated activities, and you have the, let's say, product development and day-to-day work You have engineers working with cybersecurity, working with testers, like. And all these people work in different areas, and they work with different tools, if they work with tools, and somehow they don't speak the same language. And the reason why they don't speak the same language is because they don't…

have, like, a bridge to talk together. So basically, some people are doing the documentation to, like, prepare for the audits, and some other people are basically, like. Creating, like, requirements, specification, test cases, so basically developing the product and ensuring that the product is well-developed. So somehow, the data is… Similar? But it's not communicated clearly, so they need to extract data from one system to put in another system, to sign it, a bit of a nightmare. So, TraceX is a bit of a bridge, between what we call, like, I don't like acronyms, but… I think in this audience, you guys might know what I'm talking about, that I can define them, an EQMS on one hand, and an ALM PLM, so Application Lifecycle or Product Lifecycle Management, on the other end. So…

That's really, like, an all-in-one. You can also… you can manage your regulatory work, but you can also manage your day-to-day activities, and engineers, and can work inside the platform. So that's really, like, an all-in-one. It's what it is.

So… the… what interested me about this is, Charles has taken a unique approach to, going to market with this product. And that's, to work with consultants, and to offer the product to consultants for free, so that you can extend the value of the work that you do for your clients. In other words, if you're doing quality work. For the clients, you're doing audits for the clients, you're doing this, that, or the other thing for the clients. Having them use your… EQMS platform, then you're able to, embed yourself

more deeply into the work that they're doing, and to provide greater value to the clients, and, and you get a free platform in the process, which I guess they pay for, but you don't. And So, with that in mind, you know, we're gonna have a demo at some point today, but did I do justice to the value proposition for this audience, and why they should care today?

Yeah, so that's, that's, that's exactly true. So, there is a reason, behind that. is, so… experts of regulatory, or quality and regulatory expertise, and even other stream of expertise. Human factory engineering, can be cybersecurity, can be, like, you know, like, other, other stream of, of, of work. And, and so this came up, at the really beginning of TraceX. We actually, to be fair. when we initiated, when we launched the product, like, 2 years ago, we were not so sure about the business model. We were… we knew that the product was… there was a gap in the market, as I just mentioned before, but the business model was a bit unclear.

And that's because I was really well introduced into the, let's say consultant service people in this medical device sector, then we discussed, and then we discussed, we discussed, and then, the problem was that, okay, so these guys have a different, I mean, problems, we all have problems, right? one, they like to differentiate themselves with a tool that is affordable, because, before the, the, the, the, the EQMS, let's say, that's very expensive, so if you work with small and mid-sized companies as a consultant, I mean, they cannot afford them. That's a matter of fact. That's, that's one, and then the question is that, okay, so let's say, and then to be able to harmonize

their work, so… they needed to have a tool that would be able to put all their documentation, all their workflows. What I mean by workflows, I mean, like, how to manage a Kappa. how to manage test management, how to manage unconformity. So then you will define their work… the workflow, their own workflow, and then they will take it and put… I can show… I will show… be able to show it later, but take this workflow they designed themselves. So, risk management, like, you know, you have, calculation into setup, etc, etc. So, all this stuff, all these workflows. they will be able to implement them into their client workspace, so they will be able to reuse their knowledge, so the tool enables them

To work from, to work more efficiently. And so now the second part is, why free for consultants, and why, paid for, For a manufacturer, because we see consultants as partners. So partners, so, they can, who… I mean, when you are a consultant and you work with a company, usually the company trusts you, right? The legal manufacturer of the medical device. They trust you. I mean, they have chosen you, they spend some time to choose you, and, you know, there is something that is working. It's like a human born, you know, working fine. And so, it's much easier if a consultant likes to work with a tool. It's much easier for them

to be trusted than any, like, sales guys that don't understand anything about the industry, or… I don't say sales guys don't understand anything about the industry, that's what I'm saying, but I'm saying that people that understand have a deep knowledge of what's going on, and if they like this tool, and if they recommend this tool, that means something. So, so that's why… that's the reason why, and And, that was an experimentation at the beginning, and it worked well, so we continued.

So you mentioned a variety of workflows. Can you… can you walk us through what… what they are, or, like, what if I wanted to start a new workflow? Can I start a new workflow?

Yeah, you can start a new workflow, you will, the way it works is you have, like, base… it works with cards, we call that cards and processes, and so a card is… it could be a document, it could be, like, cards with fields, so you can have, like, number, you can have, like, drop-down, you can have, like, whatever, whatever you want. And then, that's a call. You can have, like, multiple calls, and then what you will do, you will… you will build, like, the logic behind the, the workflow between these cards, and then you will say, okay, so once this is done, you do this, and this you do this, and then you do this. And then you will be able to create, the workflow exactly the way you want. I will be able to show how it works.

Very briefly, don't worry. And, but, yeah, the idea is that for consultants to be able to, I mean, anyone. But consultant, because we like working with them, to be able to, to build their own workflows, because everybody works a little bit differently, you know, and the goal is for them to be able to create the workflow they feel is right, and to implement to their clients. Examples are risks, so let's take a risk. so you will have, like, risk management, you would create your part of a risk, you will be able to have a calculation. You have a severity, you have a probability, then, you will have, is it acceptable or not? Then you will be able to, to create, to have to implement, like, a mitigation, then you will be able to, implement an effectiveness, etc, and then you will be able to reassess, and so on and so on. So that's,

That's the way it works.

So, I want to turn it over to the members of the audience for a moment, and I want them to, chime in with questions. Would it help me do X, Y, or Z? Would it help me do this? Would it help me do that? You can either put it in the chat, or you can come on live, and ask the question. But I would like to, explore, sort of, the boundaries, the capabilities of this, you know, the limitations, what have you, and try to get a sense of how it works. I see one hand… Maria?

Maria E. Donawa, MD: Yes, hopefully you can hear me, right?

Yes.

Maria E. Donawa, MD: Okay, good. Charles, what is the difference between your Maria E. Donawa, MD: program, or your product, and the whole EQMS Maria E. Donawa, MD: products that are offered. I mean, several are… a number of them are offered. So. Maria E. Donawa, MD: what's the difference? I mean, you're not describing a whole QMS, EQMS system, you're describing a component of it, if I understand correctly.

So the… yeah, you have… you have some key differences. So, the first one is that you would have not only the modules that EQMS… so. let's… let's… let's list out the modules, I mean, in a very… in a very small time. The modules of EQMS, you will have, you will have the, you will have to… the documentation, the template, you will have the cap add on conformity, you have the trainings. pretty much it, right? And then, you will have what they call ALN, PLM, that they don't do very well. It's probably other tools. You will be able to manage risk management, you will be able to manage requirements, specification, test case with trustability.

between test cases and, and trustability. That's being done not very well by EQMS. Some people try, but not very, not very well. And then you have some support tools, then you have… so, for us, it's embedded. Then you have, like, The communication with chat, video conferencing, and, like, office, you know, like, online office, so all these stuff are combined. Which are, so basically it's an all-in-one with all the different modules. Clinical, so we are… we have some modules for clinical evaluation, too. Clinical trials, sorry. That's… that's for the… the scope of it. Then you have some… the specificities are, in, let's say, 95, 99% of the EQMS out there. You're right, there are plenty.

the… do work with, you import a Word document or an Excel document. So, basically, you don't solve any problem. You don't solve any efficient problem by doing so. I was using before we were using, Master Control, and basically, it's a super expensive Google Drive, sorry, DocuSign. A super expensive DocuSign. So, you work on, on, on Word. then you import into your… what they call a capsule, then you send to reviewer to approver, you have a reviewer, then you need to download your document, then you need to make your changes, you need to update… it erases what I… it's a nightmare. So because we were working on that, what we did.

back in the days, when I was working previously, we were doing all this kind of review step outside the tool. We were only importing the tool just to sign. That's it. So that's that. So, the, the, the, it's relying a lot on Word and Excel, which makes things very not efficient. You will see the way we can review a document, the way we can where we manage the risk, test case, I mean, requirement specification, test case risk, and you have, like, you enter them, like, as you work, and then you can directly create a table. And your table is, like, live instantly. And then in this table, you can put in a document and send for review for approval.

So you don't have, like, copy-paste information between stuff, it's… you enter the information once. So that's… that's another, that's another one. Another one, that is getting less and less, a differentiator, but at least the big players at the moment don't really implement AI Agent yet. I mean, they are in the process, so… because we are all implementing AI Agent, so it will not be for long, but at the moment, it takes a bit longer for them. To, to do this stuff, because it's an older infrastructure, but we are getting there. So, for example, we… We have embedded some AI agent, to, do regulatory monitoring, or do… to help with internal audit, so I can… I can… I can mention that a bit later on, but…

that's really helped a consultant to create, actually, additional offers, or, like, medical device in general, and also, I mean, notified bodies in Europe or FDA in the US. To be able to, to work more efficiently. And the, and the last bit, is probably, important a lot for the people we are targeting is pricing. Because we are, like, if you look at, like, Greenlight Guru, for example, which is, I think, market leader, we are approximately, like, 10 times cheaper than them. For one specific reason, not because we are 10 times not as good as they are. It's because we are… we want to… for the same reason that we work in partnership with consultants, we want to onboard young companies

early on, and to grow with them. We don't want to… we don't want pricing to be a problem for them. So, so that's why we're competing with tools like Jira, Confluence. People are… are using, there, so that's why we're… we're setting up our price, that way.

Maria E. Donawa, MD: Okay, I'm sorry, I don't want to… I'm being selfish, but… so basically, you are an EQMMS system. Maria E. Donawa, MD: the whole thi- I mean, you are that.

Yay, yay, yay.

Maria E. Donawa, MD: Okay, good, because I'm sorry, I was thinking that there was just… you were doing just a part of it, and not the whole thing. You're doing the whole thing… okay, thanks, thank you.

No, yeah, I'm doing more than EQMS only, yeah.

Maria E. Donawa, MD: Good, now that's clear.

I'm gonna translate into marketing language, green light guru at a tenth the price.

Maria E. Donawa, MD: Clear.

Free to consultants, ideal for startups.

Maria E. Donawa, MD: Clarissima, yes.

Thank you very much.

I'm gonna ask Carrie to unmute.

Okay. Hi. Carrie. So… when you put in… so on the design module of it, you have a design module, correct? Which a lot of them don't. Most of them don't. So you can put in your design requirements and puts hazards, and it sounds like you have a traceability? Parts, which nobody has, and it'll automatically… trace the requirements and do all of that in your AI, and do everything for us that nobody seems to do, and…

Yeah, you added an AI word in the middle, but yeah. But yeah, so, you're completely right. So you… you can put, can put some relations between, what we call cards, and a card, you can have a card which is let's say risk, specification, requirement, test case, and then we can have relations toward them. And then, because, because we can config… I will be able to show, I don't want to spend too much time on the platform, but I would be able to show… to not bother you, right? The point is to not bother you. And then the idea, yeah, so because you have some… you have relations between them, you can have a table view.

A trustability matrix, let's save you, and then you will be able to see, what risk is linked to what requirement, to what specification, to what test case, and you will be able to see if there are any holes. In there, and then you can… this table is living, it's a living table, you know, you can… it's… you're working with them… with it, and then you can take this table. And, you can copy it, put it in a control document, and then you will… you will send to review to approve… for review and approval. It will be fixed. I will be able to show this… this actual workflow then.

Guru, Qualio, none of the others have that module. I'm just telling you. They're trying to.

Yeah, yeah, I know. But, yeah, yeah, so… it's easier for… I would say, in a different way. It's easier for us because we are more recent. I mean, the technology is more recent. So, we developed a tool that we call, cars and processes. So, from the beginning… so, these people developed modules. I mean, I… there is no blaming, there is no reproach. They were… they developed a tool 20 years ago. I mean, that's the way it is, right? Or 15 years ago. So we… we started developing, like, 5 years ago. And, we came with that approach. We were… we said, okay, we… we are not… we don't want to build modules. We want to be… to be able to… to… to build modules builder. Yeah, exactly.

So, with no code. So, once you have… so we took more… it took more time for us to build this module builder. And… but once you have that developed, then you can build these modules with not a single line of code, which they cannot do, but it's because, you know, I mean, It's… it's because, yeah, because 10, 15 years passed, and 10, 15 years in software is like, you know, like, thousands of years.

One more question. Do you offer your clients the… you do the validation for them and give them everything? For them to do.

That's a very good question, and that has been a very… a long discussion and thought. So, we are the same approach, I will… I will try to be short. That's my problem. I'm gonna, our goal is to be able to work with partners, so we don't… so we want, the way we implement the software is to work with service companies, other, like, independent consultants or service companies. So we don't want to steal their jobs, in short. So, a lot of people say, do you… it's the same response, so, do you sell templates, like, document templates? I would say, no.

Never, ever.

If some consultants want to sell them, they can, not us. It's not our job. So the same thing, so we… but we have done Like, a basic, let's say, what we call a compliance… compliance metrics. So it's a bit, so what do we do? So we reviewed all the requirements from ISO 13485, the, part 1120, 8… 820 and part 11. For the FDA, and we reviewed the requirements, of course, specific on the EQMS. And then we addressed what we have implemented, and the evidence. So, I mean, we address our traceability metric. It's available on the website, actually. We give it for free. Having said that.

we don't say, hey, this is a validation package. Why? Because it's like 90% of the job. But you always… because you… you will always have, like, let's say, a 10% to be done. And so we don't want to say, people say, okay, that's fine, and Charles said, we have that, so we can go to… no. Because you will configure, you will do some adjustment and stuff like that, and then test some stuff. So. What's happened is that some companies don't want to test them afterwards, so they want to have someone that does a validation package, like IQ, Q, PQ clean. If so, we have consultants we work with, and then they can, they can complete this validation. And we share the price, the price has transparency, and so on.

So that's, that's possible, but we, so that's consultants that, provide a validation of the tool at a very Low price, because it's not that much work. But also help consultants to have a foot in the door to companies, and then they can work on additional, you know, stuff, once they're in there.

Okay.

I don't know if it was clear.

Yeah, that's good. Okay.

Martin… And then Leo…

Okay, two questions.

I lost you.

Hi there! One party name signature, do you have it?

Yes, sir.

Wow, only part… only part 11 signature. If you're using Adobe Sign or DocuSign, this has got to cover the costs of your QMS.

I know, I know, I know, you're asking.

And the… and the other question is… Can you define your own workflow? Because you're working with startups, and these guys are incredibly creative and incredibly non-compliant. But… and they all like to use Agile as an excuse for not being compliant, but they can be. So the question is, if they can define their own workflows. with some.

That's a family.

Compliance Monitor, then this is great, because it gives them that flexibility that they need.

Yeah, yeah, they can, they can, they can build their own workflows, yes, absolutely, they can, yeah. That was that flexibility.

Okay.

Helps your world, though.

Leo.

So I'm gonna ask a question that Bayout asked first on the chat. Where is the data stored? U.S. cloud rep. What? within reach of the U.S. Cloud Act.

So, the data is, can, I mean, it can be stored anywhere. It's, it's not my answer, right? But, so it's an open source platform, I can explain what open source is, but, we can install, the tool, anywhere. But, for the people that are using, the, let's say, the SaaS, We are currently hosting it, in Europe, in Germany, it's called Etzner, in Germany, for one reason. a main reason is that, let's say, the majority of our users are based in Europe at the moment. It's not totally true, because we have a couple of… some of them in the US, and some of them more east, but the majority is Europe.

But the question is, the same question, this question will be asked, when we have, like, more users in the US who can easily have an instance in the US, and more users, so we're also developing in Asia. We have, like, partners in Korea. And and so that's exactly the same question is gonna be… is… is… Is gonna come. And there is absolutely no problem to… yeah, sorry. And it's absolutely no problem for, For, changing, changing, infrastructure, hosting provider. We have done in the past. We were… we were at Cloudflare, originally. We moved to Edzner, for, technical reasons.

But, it's totally possible to move back to Cloudflare, it's totally possible, I mean, That's also the beauty of, like, modern tools, is that we can sort of easily… we are not embedded in a hosting provider. We can easily move them.

Okay, now to my question. So, it sounds like with the, design control process, you're pretty flexible. I can work within… anywhere within the design control process. So, like, I have… I work with active medical devices, but there's a lot of… active implants, or there's non-active devices, or drug-device combination products. Any of those can be worked on. And anywhere within the design control process. So, like, I deal with EMC test plans, and safety test plans, and identifying standards, laws, regulations, guidances up front, which I pound on my clients as design inputs. And they never do up front.

But I want to make sure that process is embedded right up front in the… in the ecumen.

So, to part of your question. So, the first one, you mentioned, like, different types of class of medical device, and so what, current consultants are doing is that they can create workflows based on… they have different workspaces, and they can create, workflows of their modules, based on their… the class of the software, because it can be either very complex or less complex, you know? It can be, like, a lot of, like, checkpoints and controls or information. So that's… possible, so some consultants are doing all documentation as well. So you can create, let's say one template workspace. Per type of, per type of medical device. That's highly possible. And then, based on your new client coming, you will choose the

template document or your template workflow that you have created from one of them. That's yours, and you would just pick the one that matches to be the closest to your client. And then, of course, there is some… always a bit of adjustment that's needed. That's the first, one. The second one is to be able to have, let's say. phases, right, in the workflows. And then, absolutely, so because you would have created the workflows ahead of time, you would be able… they won't be able… so… They would have stage gates, in, in, in their, In their activities. So in… so let's… let's take, I mean, an example of a kappa. If you decide, to,

to put, like, a various control steps in a kappa, then there are no way they can move from, you know, beginning to the end without going through all these steps in the middle. They can go… so, with software, you cannot go around it, you cannot… it's impossible, you cannot cheat. That's the beauty of it. And, also the, you know, we're European, like, the source of Europe, we… so, less control is better sometimes, and, but, but you cannot cheat anymore, that's, That's, beauty and not beauty of it, you know.

And one last question. Please, please. Since I'm not a QMS expert anymore, I'm more focused on product safety and compliance, and supporting the regulatory side, I'd want to work with someone that's dealing with the EQMS, so do you have instances where multiple consultants are working on the same company together in your system?

That's a very good… that's a very good question, because that's exactly, what we promote. So, there is, inst… so, these consultants don't work alone. There are, And it's getting more and more like that in Europe, so you have consultants. I mean, people have less and less people in-house, and I'm promoting this kind of model. People have… companies have less and less people in-house, but they will have, like, a small team in-house, and then they will use let's say, RMD consultant, or… it's usually all the same as quality and regulatory. They can have a clinical trial, they can have HFE, human factor engineering, they can have, like, test management. Anyway, you can have, like, multiple, multiple people.

And all these people will have access, of course, with different roles and permissions, obviously, but will have access to the same workspace. And sometimes, so through the platform, that's the beauty of it. That's what, that's what I really love, that these consultants that know, and they're doing different stuff, I said human factor, I mean, whatever. they can, they know, which one, which people know about the platform, and they can bring people in and say, hey, I'm working on this project, and guess what? We know, we need a human factor engineering. I know you are working with Tracex, so can you, you know… and then you just give an access to this consultant.

And they can come and work on the project. And because it's free for consultants, any type of consultants, that it's free for the company. There is no additional cost for the company.

Great, thank you.

So, we had somebody write in a question, And I'm gonna go to the chat file. What stages in the product development can this tool be used? Early? Continuing? What are the key strengths and weaknesses of this tool? So, I'm gonna, I'm gonna put you on the spot, and I'm gonna say… What is a weakness of this tool? And then… then we'll go to the strengths, and then we'll go to the stages. I'm sure that you're gonna say every stage, so I'm gonna just shortcut that.

Yeah, Sage is probably, what's the weakness of the tool, I would say is, is, is youth, youth, is youth. So we are in the, in the, in the market for the past 2 years. It's… it's an advantage and a problem at the same time. An advantage because, as I said earlier, we can be more efficient, more modern, blah blah blah blah blah, but in the other end, Of course, people would like to, go with more, like, mainstream, so bigger corporation would like to go to mainstream, like Greenlight Guru and stuff like that. So, one weakness would be probably, like, let's say the credibility over the years. Like, okay, how many audits have you been through? Not you personally, but companies. How many audits have you been through?

for example, I will never work with Pfizer, or, I mean, not never, but I'm not paying to work anytime very soon with Pfizer, or with Bayer, or with, name it, right? Baxter, I mean, name it. because, because, of course, this is, We don't have the credibility for them, so that would be probably our youth. The, the, the, let's do… the… The weakness, let's say.

Hmm. Okay, and the same…

I can't find… I can't find all the ones if it's not, if it… if it's not convincing enough. I can find other witnesses.

No, no, you don't need to find other weaknesses. I just wanted to start you out with the weaknesses, to keep you honest. The, and then the strength?

Now, the strengths with no, With no doubt the, the config… the highly configurability, I mean, we… that's… that's what we worked on for so many years, and that's… that's a hole we saw in the market, that you have tools for this, for this, for that, and it's very difficult to have a tool that can do everything. So the highly configurability is definitely a strength, yeah. I mean, I'm convinced about that, because we… that's the goal of the tool.

That's good. So, I want to give you time to present the platform. No, if that's okay.

You know, of course. Can… can have a tour. I think, we discussed a use case with, like, Risk, requirements, and trustability metrics, so that could be a good, A good one to, so let's… Let me share… am I on the right one? Let me… Okay, so… I'm thinking I'm showing the right one thing? Yes, it looks like it. Do you guys see the platform? I mean, it's cream, whatever that is.

Maria E. Donawa, MD: the.

Okay, so I will, I will be quick, but just, just to show you a couple of, things. So, one thing was really, I can show Kappa, for example, but to show, we implemented various processes, and for example, one that we implemented is basically how to manage Kappa. So we implemented a workflow. I mean, this is an example of workflow we implemented, so we can say, okay, I will be very, not inspired, right? Quality event, I mean… Okay, quality event one. So… Then, we, can see, here, we can fill the quality event, so of course. That's data that we have, filled, all the fields

We, we, we mentioned them. So let's say, I mean, okay, I won't put any data in. You know, you have some drop-down, you have, criticality assessment, you have the, even classification, so that's… all this stuff have been configured, and there are… they have been, like, it's an example. We can create, like, whatever difference. But then, we have filled, these values field, we can confirm. Then you can see we have different to-dos, and just to show you that We see… we receive the to-dos, we receive the to-dos here. So, if I go back here, so I can, add a corrective action, for example. I'll do it from here for you to see. Add a correction, sorry.

That was just, like, an example that was given by a consultant that was happy to share, the, the workflow. Correction 1, for example. The owner, I'll put myself, is gonna be much easier. As the owner of the correction. Then I can stop adding a correction, I can add more correction, or we'll stop adding corrections. Then I can see that I received notification, the correction so I can feel, my correction. So, okay, I will film a correction. I would say it's completion here. I'll say save, Okay, so my correction is completed. That's my notification center, so I can see when I have something. I can add a root cause now.

Again, don't blame me if that's not a workflow that you like, it's just a workflow that was proposed by someone, right? That's just to show you an example. It's not even mine, that's something that's root cause 1, for example. Then, a responsible person. You have it here, you can save. And then… I can add additional root cause, I can stop adding additional root cause. Oh, sorry, if I go down, you will see, and that's what we discussed a bit earlier, you can see the relations here. the correlation of the quality event with my correction, you can see it's completed. Of my root cause, we can see it's in progress, and so on. So, now I will stop adding root causes.

You can see, in my root cause analysis, so I'm asking I'm being asked to write, so let's say why, so let's, because. Okay. Results… Final root cause. Let's not take real example, it's just… as a bit of a Then you can go, you continue. it can continue. Is it Kappa required? So in that case, somehow, they merge corrective action and preventive action, so it's like, is it Kappa required? We say, okay. They say yes. And then they can add kappa, let's say Kappa-1.

I'll always put myself, but imagine, Brad Pitt is busy. I can always put myself, and, And, but of course you can have multiple people, right? so I stopped using Kappa, so you can see, still, everything is, woke, Linked. You can see, here I can feel, my copper, so it's open at the moment, so yeah, you can have, like, auto, we can have various views, so… I put… Okay, magnificivist criteria, my objective of closure, who's gonna review my, this, my plan. Then I sent for review, send it to myself, doesn't make much sense, but whatever.

I can go through it. You can see that I can fill. Is my Kappa completed? Yes. Is my CAP 15? Yes. That's… all these fields have been, really, really, configured, so everything can change, all this logic can change. Then I can send for review of, of the completion, right? And then… And then this is… this is done. And then we can… we're gonna see our main card, which is a quality event, and we can see we have no section that triggered. And we can feed it. We can confirm that correction is completed. root cause analysis is 2, Kappa is there. So we could have multiple of everything. For the sake of efficiency, I've just put one, but then I can fill the monetary

Are all the capaca completed? Yes, I'm gonna put it to myself. And… I can, the approver is gonna be myself, too. And then I can send to, a review and to appro Here we go, so that is complete… fully completed. So, and then we can see, all the, all the, the quality event, we can have the list, we can have the trustability metrics. I would like to show you, just very briefly, a trustability metrics, because we talked about that. So, earlier, we talked about trustability metrics, about, Here, so you have the risk, the requirements.

the specification, the test case, and the execution. But let's say, for the sake of the demo, I would just remove it. Here, and then you have all these fields. I can actually add more here, it's no problem. And what I can do is that I can copy this table, so it's another use case, but I copy my… because we talked about that earlier, you can see that the test case is passed, fail, passed, fail, etc. And, and then I would go to control documentation, I would create a new document, I would go to, yeah, Medispray, for example. I will select, I will select 22 metrics template, for example. Trustability.

my tricks… Products. And then, just to show, because we had the discussion earlier, I will put… so, I mean, review and approval, I'll put myself. And then, so I have the template, you can see it in drafts, and then I can… boots. On my, you know, my table here. and I have my risk, my requirement, etc. Then I can, of course. Because this, I can show the difference, refresh table, if things are moving there, you know, so I can stay up to date here. And what's very important here is why we don't have a Word document that we import, and so on, that we can send for review, so I send it to myself.

I sign… So, then it's in review, I complete my review, asking for approval, and… I approve my document. Here we go. And then you can see that my signature are there, my version 1 is efficient, I can export as PDF, and so on, and I can draft a new version, and I can continue, and so on and so on. So that's, That's overall, in, yeah, too big, too big. The way it, it looks inside.

Maria E. Donawa, MD: I have a quick question before, because we're… time is short. Going back to the Kappa, you know, uploading documents is important, backup documents. So, when you were showing the Kappa, there was a place for attachments, but is that organized so that for each step, or whatever the step is, you're able to upload the reference document? Maria E. Donawa, MD: whether it's a Word or PDF, I mean, what is the format? So, two questions about Maria E. Donawa, MD: How you can do that, and if there's a restriction on format.

I'm not sure that the question… can you import it? Can you attach a document? The question is yes.

Maria E. Donawa, MD: In other words, for all of those steps for CAPA, you have documents backing them up. It's not just somebody saying, yes, no, I did this, I did that. There's always a document.

Oh, you can reference it, yes, or… okay.

Maria E. Donawa, MD: Yes.

Okay, yeah, yeah, yeah. Okay. Yeah, okay, I see. Yeah, you can… you have a text you can reference, so either if it's a document that is inside, right? So, let's say, this document, for example, so everything you can… you can tag any document here. So you'll be able to tag whatever from inside, but if it's an external document, you can either put it in here, so you can an image, or whatever, or you can drag and drop any document, or you can attach, You have attachment section here. If it's an external document.

Maria E. Donawa, MD: Okay, yeah, because, every, you know, people who work in quality, you know, if you don't have the backup document, and if it's not consistent with what you're supposed to be doing or saying, then it's a problem.

Yeah, yeah, you can tag either internal document with tags, so that's, that's the beauty of working inside a document, or you can, you can attach whatever external document, PDF, Word, I mean, yeah, absolutely.

Maria E. Donawa, MD: Thanks!

problem.

So, we're running out of time, and I wanna, spend a couple minutes talking about, the MLV100, but before we do that, how does this compare to QM space or cognition, cockpit? Does this enable use of libraries of information to support platform approaches? I assume so, but… Are you familiar with either of those products, QM Space or Cognition Cockpit?

Easy for me?

Yeah.

Oh, sorry, sorry, I was, excuse me, can you repeat, sorry?

Yeah, are you familiar with Cognition Cockpit or QM Space, and how would this compare to that? And does this… Okay.

Nope.

Okay, and does this enable the use of libraries or information to support platform approaches? I think we just looked at, the ability to attach documents. Susan Beyond. so would you, would you be able to, for example, access a Google Drive that had a whole… series of documents in it, or anything like that? I don't know.

Yeah, of course you can, you can reference any external document inside the platform, absolutely. The goal of such platform is to remove the needs of Google Drive. We have a drive, we have an internal drive where you can store external documents, so the goal is also to replace Google… to not have Google Drive anymore. It's to, yeah, I didn't show the drive, but we have our own Google Drive, where you can store Word, Excel, anything.

Okay, great. So, last question for the audience is, you know, if you're interested in giving this thing a test drive, or talking further with Charles, please, put your, rate interested in, the chat, and, I will have him get ahold of you, and you guys can… move on from there. And… So yeah, We, are gonna publish an update, I don't know, maybe today, maybe tomorrow. Actually, tomorrow's my birthday party, so I'm probably not gonna do a whole lot of work tomorrow. But…

Are we invited?

Everyone on the call is invited to my birthday. I can put the address in the, shot, and Feel free to come to, suburban Philadelphia tomorrow. I think you're gonna need to get on a plane right now. And… Be careful.

Maria E. Donawa, MD: Well, I'm in the States instead of Rome, Sean, be careful. Maria E. Donawa, MD: You're… you're…

You're more than welcome to come. Jose, if you want to talk, please, chime in. But yeah, we're… we've had, something like 3,500 votes, and, the, Let's see… looking at the…

You want me to drop it in the chat, the stats?

Yeah, yeah. Drop, drop it in the… Oh, I'm probably gonna have to do it for everyone to see it. But…

Oh, yeah.

Maria E. Donawa, MD: As we see it.

I think the host and panel will see it, but…

Maria E. Donawa, MD: Oh, boy.

I mean…

Maria E. Donawa, MD: Okay, sorry.

Yeah, almost 3,600 votes, 400 nomination entries. Almost 200 new names have been suggested. Pretty much everybody who's in the MLV100 has received at least one vote. And right now, the lead is with 228 votes, Dr. Pallavi doesgupta, our friend Angelina is in second with 215 votes, and then you've got… yeah, you've got about 10 people who've not only been nominated, but been nominated by close to 10 people or more, as many as 30-some. So, yeah, it's been great response. I don't know about anyone else, but my updates on LinkedIn are, like, every day have one of the images around it, so looks like there's been quite a bit of traction.

Yeah, so I encourage you to share this, I encourage you to keep nominating people, and Don't nominate me. I don't… I don't need to be… I get enough attention. The, but thank you to those who did. So, and, and then I think, the thing to do would be to do a second round of voting on all of the nominees, because how many hundreds of them? Have there been, like, 300 different.

Almost 200, distinct names.

Yeah, so, it's exciting, and it's, it's, it's exciting to see, this thing taking off. Natalie, congratulations. Killing it, and…

Oh, thanks!

Yeah. So, yeah, if you, if you see people who are missing, please, please do nominate them, and Next week, I don't remember what we're doing next week, But, please, tune in again, spread the word. Follow for more, and Yeah, it just… it just keeps getting better and better.

Hey, Sean, I forgot we're birthday buddies. What day is your birthday?

The 10th.

Oh, mine's, mine's Sunday, and so is my grandbaby's.

Happy birthday, Nellie!

Thank you. Happy birthday to you! I wish we could celebrate together.

Well, this is, like, a small online celebration right now. Thank you all. Have a great weekend. Thank you, Charles, for your time and your sharing your product with us. I'll be following up shortly.

Thank you, thank you guys. Bye.

Maria E. Donawa, MD: Thank you, Betty.

Aye.