Life Sciences 360

Paperless Validation: Breaking Through Industry Barriers with Andy Robinson

July 27, 2023 Harsh Thakkar Season 1 Episode 22
Paperless Validation: Breaking Through Industry Barriers with Andy Robinson
Life Sciences 360
More Info
Life Sciences 360
Paperless Validation: Breaking Through Industry Barriers with Andy Robinson
Jul 27, 2023 Season 1 Episode 22
Harsh Thakkar

Episode 022: Harsh Thakkar (@harshvthakkar) interviews Andy Robinson (@andyrobinson2), Founder & CEO at GxPaaS.

Andy discusses the importance of customer discovery when creating a new product and shares his experience with creating a questionnaire to gain feedback from potential customers. He also talks about the challenges of transitioning from paper to electronic systems in the life sciences industry and the need for intuitive software to facilitate this transition.

Harsh and Andy also discuss the importance of finding an internal champion when pitching a product, highlighting the critical role of building relationships with key stakeholders within an organization.

-----
Links:

* Bits In Bio
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

-----
Show Notes:

(6:31) Paper vs. Electronic QMS implementation.

(11:16) Finding an internal champion.

(19:49) What is a no-code app?

(23:48) How Andy scrapped the idea of building the app.

(29:30) Validate in 4.0 working group.

(35:31) What if part 11 doesn't exist?


For more, check out the podcast website - www.lifesciencespod.com

Show Notes Transcript Chapter Markers

Episode 022: Harsh Thakkar (@harshvthakkar) interviews Andy Robinson (@andyrobinson2), Founder & CEO at GxPaaS.

Andy discusses the importance of customer discovery when creating a new product and shares his experience with creating a questionnaire to gain feedback from potential customers. He also talks about the challenges of transitioning from paper to electronic systems in the life sciences industry and the need for intuitive software to facilitate this transition.

Harsh and Andy also discuss the importance of finding an internal champion when pitching a product, highlighting the critical role of building relationships with key stakeholders within an organization.

-----
Links:

* Bits In Bio
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

-----
Show Notes:

(6:31) Paper vs. Electronic QMS implementation.

(11:16) Finding an internal champion.

(19:49) What is a no-code app?

(23:48) How Andy scrapped the idea of building the app.

(29:30) Validate in 4.0 working group.

(35:31) What if part 11 doesn't exist?


For more, check out the podcast website - www.lifesciencespod.com

Andrew Robinson:

And this thought came to my mind of like, you know, quality is a lot like barbecue in that it's not about perfection. It's about

Harsh Thakkar:

What's up everybody. This is Harsh from Qualtivate. And you're listening to the Life Sciences 360 podcast. <Podcast intro> All right, welcome to another episode of Life Sciences 360. Our guest today is Andy Robinson. Andy is the CEO and founder of GxPaaS, a product that he's building to solve the problem around paperless validation in the life sciences industry. So welcome to the show, Andy.

Andrew Robinson:

Thanks. I appreciate it.

Harsh Thakkar:

I want to start off by asking you, you posted something few weeks ago where you posted the link to a form. And the form had some very well thought out questions around paperless validation, or moving from paper to electronic validation solutions. And you went really into detail because you asked questions about execution, you ask questions about creating scripts post review, like I, first of all, anyone that's listening to this, if you're a founder, if you're building a software product, this is one of the best examples of how you should be getting feedback from users because you don't want to build something that people don't need. So I really was excited to see that you went so much deep into the form, asking very technical questions for people who've been in validation. So I want to just ask you, did you what kind of response did you get from that form? And any interesting takeaways that you can share?

Andrew Robinson:

Yeah, I seem to have probably gotten maybe around, I don't know, maybe around 10 or so responses. But what's interesting is that form is an outgrowth from a program that I've actually just finished. It's a local, I guess, incubator, I guess it'd be more of an incubator of the CED GRO program, based out of Raleigh here. And one of the things that they cover really early for entrepreneurs is this concept of customer discovery. So what happens a lot of times, especially people who've been around the industry for a while, you have an idea, you think you know the answer, you think, you know, the customer problem. So then you go build the solution. And come to find out you had kind of a narrow viewpoint. Yeah. And so this concept of customer discovery is focused on the idea of go out and ask your customers, what are their pain points are? What are their real problems? And more importantly, is this a really big problem that happens every day? Or is it annoying, and it only happens once a year, so it's not worth solving? So I built a whole series of questions, probably about an hour long interview that I was doing with customers, and I probably talked to 50 or 60 of them. And so this was a way for me to do something in a lot more compact form to get it, you know, down to the point where someone could answer it in a few minutes. Because these people I'm talking to saying, Hey, can I get an hour of your time, you can just pick your brain. These are really busy people. And so that's kind of what led me to that idea. And then I've also used sort of the questions in that form, or that layout of that format, in really short conversations, too. And so yeah, yeah, that's, that's kind of what led to that.

Harsh Thakkar:

I know, when we first met on LinkedIn and had a virtual meeting, you asked me similar questions around validation and what I've seen with clients, so when you got those responses to 10, or 12, can you share one or two that really struck out like a key takeaway that you're like, Wow, I never thought about this. I'm so glad this person shared this with me.

Andrew Robinson:

Yeah, I think what I would, I didn't get any that were, say completely out of left field. Okay. I -- Oh, my gosh, I never thought about that. But what I did get, and I think what's been the most valuable, especially in the format of the way I've been doing these questions, I have a spot where I say, everyone thinks it's Well, yeah, electronic would definitely be better than paper. So the natural question is, well, why isn't everybody doing right? Why? And so I posed the question of, what are the one or two reasons if you haven't done it, why have you not done it? And what keeps coming back? Is two big things. One is the concern around the complexity of internal policy updates? You know, because what you can't do when you're going from paper to electronic, is to send out a memo on Monday. Hey, everyone, let's start using the new system, just start typing up your protocols and design documents in the new thing. Right, right. You know, there's there's a whole ecosystem and a network of of things that have to happen to get there. So you can't just flip a switch. And then the other concern was trying, if the system you know, it's different. So you have to know the new policy, but any kind of new software system you have to be trained on? Yep. So what that did, what that has done for me is it's made me think a lot about there's not a lot I can do about helping these companies, maybe with their policy now, someone like you could, yes, I can come in and help you rethink your policy. But when it comes to training, that makes me think, okay, I need to make sure the system I build is intuitive. It's easy, it's obvious, you know, very much when you download an app on your phone, you don't get any training. Yep. It's just that, you know, especially good apps, they're intuitive and obvious. And so that's gone a lot to inform how I've tried to kind of build the platform. And so yeah, that's, those are the two biggest takeaways. I think I've gotten through the various feedbacks.

Harsh Thakkar:

Yeah, and when you were saying about training, it kind of reminded me of certain clients that I worked with, where they have, so you're talking about validation, but I specialize mostly in QMS implementation. So it's the same concept, but they have paper documents, and then they want to go to an electronic QMS. So that's kind of where my team comes into play. But I've worked with some clients, less than 30 people in the company. And they intentionally don't want to go to electronic not that they don't have the money, not that they don't have the expertise, or not that they don't know which electronic systems are out there. But they just feel that maybe where they are in their product development stage. They don't want to introduce that complexity. Because once you have an electronic system, you're bringing a whole new set off supporting processes like change management, release management, a training for that system, managing all the change controls validation paper, on the other hand, does have all those components, you do have to have change control, even on paper. But it's much easier to do that on paper versus you know, electronic system where you have to have too many hands up. That's what I've, I've heard people tell me that they're they can do it much faster on paper versus electronic. Now, when they get to a point where they have 500 or 1000 documents, then it's a different ballgame. Because then they they need searching, sorting, filtering all these new features that only come in electronic system.

Andrew Robinson:

You know, it's interesting you say that, because my primary background has been in kind of the automation side of manufacturing. So going into facilities, and you know, not only automating equipment, but in a lot of Life Sciences facilities, you tend to get a lot of good based equipment, from equipment manufacturers that already had the automation. So we will put something over the top of that, like an orchestration layer for tracking materials or bad news or things like that. And one of the interesting things I've heard through the years was customers did not want to go to some sort of electronic batch system. Because this is so ironic, the burden of changing an electronic batch record system or an electronic batch instruction or SOP system, paper on glass, whatever very, you want to call it, entirely the burden to change that was so much higher than the burden to simply update the master batch record and route it for review. So stain outcome saying scope of change, but for some reason, and when you said that it kind of triggered that memory. For some reason. People are so much more comfortable saying well, I just updated a Word document. Yeah, and I'll route and it's okay. But when I update something electronic, I think it's it's what people know and uncomfortable with someone else updates an electronic thing. And they're worried something's going to break. But if all I do is update a Word document, well that can't break. But what they're forgetting is the human The operator that can make a mistake. Yep. You know. And so that's the that's the funny irony of it.

Harsh Thakkar:

Yeah, I've heard of that. And it's interesting when people say that, but I guess there's it's just a never ending debate, because you will always have people that strongly advocate for, hey, I don't need electronic systems right now I'm fine. But it's interesting to, to see when they're actually ready. And and most times, the first electronic system that they do end up implementing is a QMS, to put their documentation and training. So I've seen companies where if they have a good, what I call the magic triangle in the leadership, which is the it the quality and like the business groups, so if those three players kind of understand a bit of how SAS systems are, or what validation is, they don't need to be experts, but they just need to know a little bit of how it works. And that makes it very easy to pitch products or to say, hey, you should go to this E QMS. Because then they can be the champions and let their teams know, hey, we're going to electronic QMS starting next month or whatever. So getting rid of people, but yeah, it's it's still a never ending debate. I don't think I've ever met one person that said, I'm this versus that. So

Andrew Robinson:

No, and I think you hit on a key point there and having I've never been a straight salesperson, but I've been involved involved in the sales process, you know, from a technical standpoint for a long time. And the idea of finding that internal champion, yep, is really, really important. Because they're going to be the one that kind of present the case entirely, and say, Hey, here's how this thing solve our pain points, man. Yeah, you're right, for a 25 person company. With 15 designed up. Well, protocols, probably doesn't make a lot of sense. And not a lot of changes. Yeah, that's absolutely right. But, you know, you get to a 200 person company. And some of these folks, they'll do it. What?

Harsh Thakkar:

Yes, yes. So I want to ask you this. I don't think I've asked you this before when we met. But when did you first get the idea of starting GxPaaS? Do you remember where you were? Do you remember when when you had? I'm sure you've had the itch for time. But you actually decide that? Yes. Doing

Andrew Robinson:

Yeah, that's, it's it's the classics founder it? solving your own problem. So they know. So you can probably go back to like the 2007 - 2008 timeframe. I was working for System Integrator before. And we're doing a really large multi year project locally. And I remember sitting there on Saturdays and Sundays, working through paper protocols, wishing I was home with my family, my one year old and my four year old. And instead, I'm up here doing this, and like, this is just crazy. But at the time didn't have the resources or the vision to do something. I'd say kind of somewhere around 2021. I'm working with biotech equipment supplier, I've been working with him for for quite a while. And I'm just kind of looking at their processes and the inefficiencies of it. And so this seed kind of it kind of bubbles back up. And it's around, they're doing FA teas and things like that. And so I actually, it's funny, I actually remember like the day and and the location because it was just kind of, and it was December 17 2021. The reason I know that is because we're on our way to Mexico for a one week vacation, where we're coming back on Christmas Eve. So yeah, I don't have a photographic memory, but I can sort of slot it. And I was texting a friend of mine who's a consultant in the industry with a pretty large organization. And so they're kind of in a catbird seat, he can see a lot and is like, hey, if I brought a new paperless validation system to market, do you think there's room for it? Because there's some competitors there. You know, there's people who have been around for over a decade, and they certainly dominate the mind where you go look for a product and you find it real quick. And his response was, absolutely. And so the next question was, well, don't the existing people already kind of have the market cornered. And he's like, well, not as much as you think. And a lot of their customers aren't super happy. And that was kind of my okay, there's the opening does from the outside it looks like the market It's captured, there's not really room for a new player. I thought about how big the market would be. But when I hear those two things, I texted him back, I was like, thanks. You just ruined my vacation. I spent a lot on them. And the funny thing is, we're going to one of them little resort places. Yeah. And I went to the gift shop looking for a notebook because I didn't, I didn't bring anything to write on because I want to write, I couldn't find this thinking notebook less than$20 going to have to type these thoughts on my phone. But yeah, that was kind of the that was kind of when it all kicked off. I was still doing my normal day job. Yeah, yeah. 40 5060 hour weeks, and then kind of working on this off to the side. And just kind of see and through customer discovery and, and other things, other activities, to be like, hey, is this is this really a thing? Is it? Is it something Is there really an opportunity?

Harsh Thakkar:

Any any advice for people listening who either you know, right now are working at a stable job or have a have a good job, but they want to start something on their own, whether it's a product or service based business, any advice that you can give to folks on how to find that, what they want to build.

Andrew Robinson:

So I think there's a few of them. One is the V initial find what you want to build out. Again, go back to the classic, what bothers you like, well, you know, I see these Y Combinator Tech Stars, yep. 21 year old guys are like, I didn't know how to code and I'm a great marketer, let's go find a problem. Usually, those end up blowing up spectacularly, even after a million dollars funding, you know, think about what like, what, what, really not that. But then. And this is the really important part is go do that customer discovery work. Because what that does is first, that's going to give you some really honest feedback, which is not what you think is a problem. But what everyone else thinks is the problem. And if you go out there, and you can only find 10 people to talk to you in six months about the problem. That's the market telling you either A), you need to look a lot harder, or expand your network dramatically. Or B) maybe it's not really a problem. Because you build a product for 10 people, it's gonna be hard to be successful. So those are the big ones and then leverage it I've seen you talk about this a lot. And I've used it, leverage tools to help you. I'll give you a perfect example, I went to intersects the big trade show in New York. And I'll probably get in trouble for this. But that's okay. I don't think they had any explicit roles, you may have been able to quote unquote, by the list of people who are presenting there, but I couldn't find that anywhere. And I can't, you know, I'm not going to pay$5,000 for that list. So the first thing I did is pretty good little PowerShell script or, but I wrote a little script that went page by page and pulled down, you know, you can page through 1, 2, 3, 4, 5... 10. And I pulled down the list. And then I sort of parse that up a little bit. And again, I'm I would not consider myself a hardcore coder. I script. Yeah. And I pulled down the list and and I got my list of 600 pairs, you know, people who were at the trade show, not the attendees, but the companies love it. And then then I use an add in for Google sheets that calls chat GPT. And I asked that GPT give me a one sentence description of what this company does. And if they sell to GMP manufacture, and holy cattle, it was I mean, some of this stuff was just straight marketing copy from your website. And others was a really interesting synthesis of a bunch of different stuff. And I look through this list and I'm like, okay, these are the people I want to go talk to. And so use these kinds of tools. Oh, and then the other thing I did is I made a little glide app with all the companies I wanted to talk to with the information and the demographics. And as I went and talked to each of them, I kind of went around the corner, and I typed up my notes, and I was like you I'll follow up with them, or they like, Get out of here, man. We don't want anything to

Harsh Thakkar:

Glide. Is the no code Glide is a no code app that you, I've heard pf

Andrew Robinson:

Yeah, it's a no code app that you can make a little mobile app and then you can Back it up with a Google Sheet. Yeah, it's fantastic. Yeah. So that's the big thing for me is after you get to those first to use use all these tools and technologies to take shortcuts. And at the end of the day, you got to figure out, Is this a real business or not? You know, is there something there?

Harsh Thakkar:

Yeah, yeah. No, I mean, that's, that's really important. Because there are always ideas, I got a lot of ideas, I wanted to say, at the worst, probably the worst time when my after my son was born, because that was like November 2020. So from like, November 2020, to probably Feb. 2021. So like those first four months, I was up late at night, you know, obviously, because we had to take turns, somebody has to have the monitor. And I would be up to like 3, 4 am in San Francisco. So I just had my my office and people that work with me know this. So I had like a desk. And behind me was a bookshelf. And I had one of the beanbags that converts into a bed. So the beanbag would be in the corner. So I would just be like, researching, working, because remember, I had a full time job. So I was working from like eight to five. So if I had to think something, the only time I had was that after 9 pm. And after, the kid was in bed, and I had the monitor. I was like, Okay, now I can just have a cup of tea and think about, that's when I found the lot of ideas. And that's when I decided actually to that three or six months down the road, I'm going to quit and do something on my own. And then I started the consulting practice. But yeah, I mean, I had so many ideas, I remember one that I can share, and I did something similar to what you just mentioned. So I had I was listening to, I forget which podcast but I was listening to a podcast and the people on the podcast, sorry, if I'm going to limit tangent, but this is exactly, yeah. So the guy the guy on the podcast was they're just brainstorming ideas of how to build something and how to find. And they said, Oh, you know, a great idea right now is to target people who are 60+, and need help with technology. Because there's a lot of technology, and people who are in that age demographic, if they've had a job in it in their career, then they probably no things. But if they haven't, then they can't even figure out a simple you know, how to install a ring doorbell or whatever, how to install a Google nest or the simplest of the things they can do it or it's hard for them to learn and you know, do that. So the guy was like, somebody can build an app. And it's basically like Geek Squad, but for this demographic 60+,

Andrew Robinson:

So jitterbug. Jitterbug, Geek Squad. Yeah. Something you're on your flip phone? They probably still have those commercial,

Harsh Thakkar:

Yes. So I kid you not, this is real. If I have screenshots, I will share it. But I learned about no code. That time. I learned like, for two months, I was taking all courses on no code following every single no code, person on Twitter, learning all the tools signed up for everything came across bubble, which is a web, no code web development platform. And I started I even have the wireframes that I designed. I called I call the app tech to me. So instead of talking to me, it was tech, okay, detect me and build the entire thing on bubble. But then at some point, you know, I don't know what what happened. But I kind of scraped the idea because then I started finding, there were a lot of other services out there. So Best Buy's have really well known one. But there's a lot of other apps and other small service based businesses who have partnerships with big dealers, like retailers like Costco and target, stuff like that. So it was it was, as a user, if I went to buy a TV or something, I'm more likely to get that installation from the retailer versus leave the store and then try to find something on my own. So I got some data and I saw that majority of the people do that. So like I would lose out if I can get into that retailers database, or they don't show my app to say so. Yeah, so somewhere But along those lines, I basically did what you're saying just tried to build something over two or three weeks got really far. And it was like really exciting. But then I'm like, No, I don't want to do this. This is just always fun, but move on to the next.

Andrew Robinson:

But you know, the the great thing though, what's the couple of interesting things there? Number one, is you're able to do that for probably almost zero cost. Yes. Which is something that's so different from even 10 years ago. Yeah, like we can validate these ideas. Oh, yeah. The other thing, though, is you talked about the idea of you spent a couple of months just taking classes online and learning. My son has recently gotten into photography, and so doing sports, photography, dog photography, all this other stuff. And what he's producing is just amazing. And literally, all he has done is find websites and the whole network of people who do this online, and YouTube, and that's how he picked his camera and his lenses. And I think about when I did it, or when I was young, I went and got the Ansel Adams book, and got my dad's Canon camera and got my 35 millimeter film developed at the drugstore. You know, it's just Oh, different.

Harsh Thakkar:

I have somebody in my wife's side of the family. And he's also a teenager. And he, I forget what it was he was working at a at a car. I don't know what he was doing. I think he was he was always fascinated about cars. He used to go to these shows in his lives in Pennsylvania. So he would go to these shows where they have all the cars, and he would just click pictures of the cars with his iPhone, then he got a camera, and he had an Instagram account. So he would post those pictures like, hey, look, I'm at this trade show in Hershey. I'm just, here's the new BMW 2023 here's the rims. And he would like go really and take a zoom of the red brake calipers on the rims like he was yeah, it was real thoughtful about. And then that turned into now he's a professional photographer, and all the automobile like shows where these happens. The car dealerships call him like, Hey, can you come and do shoot also, like he literally does that and post on Instagram, then he now is also doing a video where he will be in a different car with the cam, and then a professional driver, you know, turns on the engine and and then he'll take like a motion of that. I don't know how it wasn't good. He showed me some of his videos. And I'm like, crazy. Crazy.

Andrew Robinson:

Yeah, just, you know, I think the key there is to get back to the entrepreneurship thing. Yeah. If you're trying to build a business or brand, because you saw somebody else making money doing it. It's not gonna work. Yeah. If you're building a business or a brand, because something you're passionate about, if this guy just really enjoyed cars, taking nice pictures. Yeah. And happened to be good at it or probably wasn't very good in the beginning, but kept learning and getting better. Yeah. Yeah. That's a lot less of there. Yeah,

Harsh Thakkar:

It's interesting. Like, I don't think he's still I met him three. I met him like three or four months ago. And he's still doing that. He doesn't have any other gig. He's traveling. He goes to California. He goes to LA he goes all over the country with his camera and backpack. That's it.

Andrew Robinson:

Yeah. No, that's fantastic.

Harsh Thakkar:

So yeah. And I wanted to ask you another thing. You, you talked about network, I think you talked about networking, or finding, you know, finding this, you talk to a bunch of people when you are building. And somebody like you said, told you texted you and said this, and you were in Mexico, and you're like, Wow, thanks for ruining my vacation. So I see that you're also involved a lot in ISP groups. And also you are in a lot of events in the Raleigh area of speaking events or your host you're hosting them or you're part of the management of those events. They're talking about, like ISP, like what are you doing there? Because I know you're in that validation, special interest group.

Andrew Robinson:

Yeah. So I'm in kind of a couple, a couple of different groups, you know, loosely, you know, one very tightly connected and one a little more loosely connected. Yeah, I've recently joined the Validate in 4.0 working group. So you hear the term industry 4.0 And so then there's this term pharma 4.0. Sorry, everyone kind of puts 4.0 on everything, right. Yeah, but the the big picture and how that The vision there is that if, if we can capture data at all of these different stages, which funnily enough, a lot of people are capturing data about things, and systems and equipment at different stages, right, but we don't do a good job of tying it all together. You know, we don't do a good job of even though people leverage, you know, say we, if you're looking at qualification, and things like that, we probably don't do near as good of a job as we could have, you know, leveraging supplier qualifications, um, one of the big things for me, and it's gonna be a big consideration for me is baiting about you know, I'm, I'm building a SaaS platform, right customers and not going to do an IQ and oq on my platform. So how do I interact with my customers, and give a really effective handoff to say, here's what I've done to ensure that my systems operate properly. And, you know, here's the sorts of things you may want to do as a quality activity. I think there's going to be a lot more of that going forward understanding for practitioners like you, yeah, you know, on site, the MES versus the SaaS, very different plan. So that's a lot of what you know, validation for a working group is about I'm pretty new to it. So I'm still kind of getting my feet wet. And they're not part of another little more ad hoc group that spun out of a conversation around Computer Software Assurance back in February. And the short version is, I was like, it'd be really nice if we had you know, CSA is got some nice practical scenario based guidance toward the back. It'd be cool if we had something like that, or part 11. That also maybe wasn't $295 document, which is a whole different topic a lot of us in ISP talk about is the gatekeeping the power expensive it is to denote what you're supposed to do around again, hold different show. But anyway, so a group of us kind of spot out of that myself and from Pro Sela, you know, offered to step up and help. And what we've actually started doing is going out and engaging the community. And I started with a post in the one of the forums, as Hey, everybody. Well, what happened is the FDA came out and was like, you know, that part 11 thing? Don't worry about it. Just just ignore it. I'm serious. Because it seems outrageously provocative. Gosh, yeah, we need that.

Harsh Thakkar:

Yeah, we need to link that link that in the you can send me the link to it, we need to put that in the show notes.

Andrew Robinson:

Yeah, we got to be careful, though, because it's in the community of practice, which you have to be an ISP member to get to. Yeah. But anyway, so. So basically, I put this post out there, and I backed it up with the idea of, hey, by the way, go look at 211, which everyone gets confused part 11 to 11, which is the predicate rule. That is, you know, for drug products and things like that, I think med device 820, or something, I've never worked in med device. But the point is, if you go look at like, you will love it, and you read it, what you find is, it's not all the basics that you need. If you're operating a system that's capturing electronic data, you know, you should, you should make sure people are authenticated people are doing who they say they are, you should backup your data, you should make sure that data is recorded accurately, and people ought not to muck with it. And so I got a really good response out of that. And it was almost like people kind of coming out of the forest going. Yes, yes, we agree. We agree. You know, now, is the FDA gonna rescind part 11? I don't know. Although, it's been talked about kind of on public panels of it's not the craziest idea ever. Yeah. But the big theme a lot of people came back with and honestly, I'm seeing it with CSA now, too, is there's a lot of people who feel like part 11 actually ended up being contributing to more confusion than clarification. Because now when you get a requirements document, they just have this huge checklist. And as a supplier, I'm like, that doesn't apply to me at all. Is you even think about that. No. So that. And so so Yeah, that one's that's really interesting. And so, as a group, we're kind of continuing to meet like, once a week, once every other week, and to see, you know, what are the sorts of activities we may do? I think we're actually We're going to be hosting a special interest group in a couple months or something. I don't quite remember yet. I'll, if I get the details, I'll send them over to you. All right. Um, but yeah, so now it's the idea of how to challenging the status quo. And you talk a lot about it on LinkedIn of like, don't do it just because this is what we've always done. Right. You know, there's, there's a, you know, think about it, distill it down. Yeah, that's kind of the spirit.

Harsh Thakkar:

I never thought about the, you know, the post that you made, that you talked about, like, what if party living doesn't exist, but like men? Yeah, a lot of no offense, but a lot of consultants will be finding different jobs.

Andrew Robinson:

Well, so one of the one of the key takeaways, or one of the key things I kind of posited in there is, is the idea, say, I don't know if consultants will lose jobs,

Harsh Thakkar:

because I said, finding different jobs, find a different job.

Andrew Robinson:

But the idea is, are you going to one of the things of questions I asked, Are you gonna stop making people log in with unique credential? No. Are you going to stop backing up your data? No. Are you going to take off the audit trail? So you know, if something got updated? After? No, why? Because all of these things are things you should be doing if you're writing a good piece of software. Yep. So the business wants to do this, because it's good business practice. It's good quality practice. It's just ingrained at it. Yeah. So the fact that, you know, whether there is a guidance document from the FDA not Not, not the actual predicate rule, which gets people a little spot up and confused, it's a guidance document. You know, the fact that that does or does not exist, is not going to change. What good software looks like, I agree. And so, so yeah, it's yeah, it's been fun.

Harsh Thakkar:

It's fun. Yeah. And it's, you know, it's a whole different topic. I mean, a lot of the things like you said, Are you are you going to stop doing that if part 11 doesn't exist? You know, the answer is no, because it's all it's all practical. It makes sense. It is, it is what you would do if you're putting your data into any electronic system is just common sense, right. But when you say that, people don't like it, I, one of the first post that I made on LinkedIn that went, that was, I don't want to say viral. I don't like that word. But it was a lot of people were engaging with that post, I think I got like 30 or 40,000 impressions, which was the first time on one single post. And I think the first line of first or second line of that post was just like, quality is not something different. It's just common sense or something like that. I don't remember exactly. And I had people with 20 3040 years of experience, commenting, I had people messaging me saying, you, you are just disrespectful, like you don't understand quality, how are you even a consulting business in this space? And you're seeing these things that quality is common sense. Like, people have, you know, PhDs and quality management is so difficult. And I'm like, it's you're not understanding the message? Yeah, I'm not I'm not saying everything's not meant to be taken literally the way it's written. It's just somebody has to say that to get people to think I'm not saying it to do literally to say, equalities, common sense. But I'm trying to get people trigger you to think something different.

Andrew Robinson:

Yeah. And that's the spirit of what I wrote. And there's definitely a few other folks out there in the industry who will do things like that. Yeah. Like the the person. Grace works with Dory, at Procell. You know, she's, she'll do the same thing. She'll put something out there a provocative question. Just to sort of knock you off your normal day to day and be like, Hmm, maybe I should rethink that. Yeah, though.

Harsh Thakkar:

Yeah. Well, listen, it's been really amazing talking to you and learning about what you're doing. I know we you had a you were at an event in Raleigh and Durham, like, last month, I was going to come to that one. But I had to travel so I, I wanted to come and meet you in person, but maybe try to come to another one. If you have is that what is it? Bits and bio event?

Andrew Robinson:

Yeah, yeah. So So talking about getting out of our network. So yeah, so bits in bio is a community that it kind of started up in Slack and his talent grown all over the world. Really? Fast and, and kind of their mission is, is looking kind of at the intersection of software and biology. So you hear about AI enabled drug discovery. That's kind of like one extreme. But then you know, the other side of it that I think is closest to what we do is like these really fancy new electronic lab notebooks cancelling and Ganymede and some others. And so I thought the topics they were talking about, were interesting. I like to read and learn about things that are, you know, outside of my sphere and see if I can grow a little bit. Yeah. But then I found out there was a local, I don't want to call it a chapter but a local group that met and so I started going to a few of those and engaging with speakers and you know, chit chatting with everyone. And then the group leader ended up moving away. I think his wife got a really great opportunity in Houston. So they've moved to Houston. He's like, Hey, you want to take it over? That? Okay. Sure. Wanna? So yeah, so we meet the third Tuesday of every month, we've actually got one coming up next Tuesday following you know, when we're recording this in downtown Durham at biolabs. And obviously, will we get a speaker, but I hate the call of the speaker, it's more like a fireside chat with a PowerPoint. Because usually they'll get up there and they'll start talking. And there's so many Wellborn people who tend this out a huge group, you know, 1015 20 people, but then it'll just turn into just like a dialogue and conversation. And oh, by the way, oh, I have another PowerPoint slide. Let's go to the next slide. Because I cover that topic here. But yeah, it's it's it's a really fun kind of casual group. The range of people there is all over the place. And yeah, um, uh, you know, just trying to kind of get grow it, you know, reach out to a bunch of folks who are kind of interested. Yep. So yeah.

Harsh Thakkar:

Yeah, I'll have to check it out. You said it's on Tuesdays, right?

Andrew Robinson:

Yeah. Third, Tuesdays. Okay. Yep.

Harsh Thakkar:

Before we wrap this up, I have one question for you. We're in the second half of 2023. What are you most excited about between now and end of this year? As sake?

Andrew Robinson:

The biggest thing I'm excited about? I think one of the obvious is, is getting my kind of vision brought to life, getting the first few commercial customers launched, because we've taken the kind of a really slow and steady approach. You can't launch a quality system that touches quality, it just kind of works. Yeah. So getting that launch, you know, getting the first few commercial clients. But then the other thing I think I'm really excited about in a more general sense, is kind of learning and understanding more about a lot of the new AI platforms and tools and how they're becoming democratized. Yeah, three months ago, you wanted to read a Pete read a folder of PDFs and summarize them with questions. That's kind of hard, maybe six months ago, yeah. Now you look on Twitter or Google searching, you have 15 results. So people are like, Oh, I've written these giant libraries. So you go, it's four lines of code. And so just the democratization of these insanely powerful tools is what's really exciting to me. I guess, you have to do that to get it to the masses, getting it to a lot closer and no code style, which a lot of people are building and experimenting with. So that's, that's what I'm really excited about.

Harsh Thakkar:

Yeah, it's something I've also played with. And I don't get much time outside of project work and stuff. But it is something at the back of my mind that I always try to play with specially the AI tools and how they're how they're being used for just simple use cases. So I am, I'm doing a lot of research right now. I haven't posted enough content around that topic, on LinkedIn or on other channels, but it's something I'm researching a lot. But once I have, once I have the engine ready to roll, then oh, yeah, non stop.

Andrew Robinson:

Yeah. Cool. Yeah.

Harsh Thakkar:

Where can people connect with you or find you after the show? If they want to talk to you? You want to share your social?

Andrew Robinson:

Yeah, I think the easiest place to connect with me will be on LinkedIn. You know, just find me. I'm Andy Robinson. I think it's like Andy Robinson too, or just Andy Robinson on LinkedIn. I'm in Raleigh, or we're connected on there so they find you you know where I am. Yep. So yeah, I love connecting with people. I'm having more and more get togethers just having coffee for no good reason. chit chatting about people who may or may not be in my logical network, but I love meeting new folks.

Harsh Thakkar:

Yeah, appreciate you coming on. I know we were planning about this one for a few weeks and had to push it out. So thanks for coming. Any final words before we close it up?

Andrew Robinson:

I'll say one final thing I was, I was thinking about the other day when I was I was putting on a shirt that my kids had gotten me because I don't buy my own clothes. I hadn't done it last 15 years. And it was a barbecue shirt. And I have a barbecue snob. Like really bad. Oh, yeah. And it this, this thought came to my mind of like, you know, cuz you like to make a lot of analogies. Yeah, channeling my inner Harsh. A lot. You know, quality is a lot like barbecue. In that it's not about perfection. It's about doing the right things to get a good result. And more importantly, not being afraid to sort of adjust your process as you go along, you know, play with the temperature do this and do that, and understand how that kind of impacts the outcome. And so but again, the general premise of qualities like barbecue, it's not about perfect. No, it's just about trying to get better. So yeah, that was that was though something that just again, you came to mind the other day.

Harsh Thakkar:

Yeah, it makes, I've never heard that for first of all. So that's a that's a very interesting market. I was I was planning to end the podcast at this stage. But now it's like, you know, might be a completely different, we might have to do a part two, about or x y quality is like barbecue. Sure. It's, yeah, it's, it's, I see what you're saying. Because it's this this thing about barbecue. I mean, I don't, I love barbecue food, I don't nearly do it cook it as much right now than I used to five or six years ago. But like, all different kinds of barbecue, there are some common components, you know, you have your dry rub or marinade or you have the protein. And you have the fire. How are you using charcoal wood pellets. So like, if you look at the components, it's like, all you have the fire, you have the protein and you have the marinade or like the flavor. But then when you open the world of barbecue, it's like, every kind of brisket, if you get one from Texas, North Carolina, Kansas, whatever, they all taste different. They have the same ingredients. It's just like you said, you know, what temperature were they cooked at? Was it high at first and then low and slow for the next few hours? What was the marinade kept for two days? Or was it kept for two minutes? Like there's so many little things that people do with with that, even though this the ingredients and the components are the same basic stuff, but the end product is so different.

Andrew Robinson:

But the end product still completely acceptable? Yep. See, that's the key. There's not a single Yeah, like you said, different briskets Yeah, on different pork shoulders, different ribs, you know, now there are some that are just flat out wrong. And we can talk about that.

Harsh Thakkar:

Yeah. And it also, it also matters on like the quality of the protein like you know, if you're doing organic versus green or grass fed or organic versus not. But but in theory, it's, you know, you have your cooking source, which is propane, charcoal, or wood pellets or whatever, you have your protein. And you have some of the flavor either that's dry marinade. I don't think there's anything more to barbecue than these three. But it's still like such a complex topic for people who love it. They spend hours and hours going to competitions and competing food trucks. That is just a whole world of Yeah, people, especially in us, I was like, wow, people love.

Andrew Robinson:

It's there, and especially in Texas. Yeah, I lived there for five years, I thought.

Harsh Thakkar:

All right. Thank you, Andy, I love talking to you. I'll be rooting for you wish you you know, a lot of success in the second half of 2023. If you ever need any help, let me know. And for folks listening, if you are, if you've experimented with paperless validation products, or you're passionate about validation, and you just want to bounce off ideas, reach out to Andy have a conversation. He's He's I completely believe what you're building. And I think, from what I've seen so far, what you've shared, and I know we can talk more later, but it's really your vision and what you're trying to do and how methodical you are with the process. I'm I'm pretty sure that the outcome and the end product is going to be significantly better or comparable to all the other products out there. So I'm rooting for you. That's the goal. That's the goal. Thank you have a good day.

Andrew Robinson:

Thanks Harsh. Appreciate it. Take care. Bye bye.

Harsh Thakkar:

Thank you so much for listening. I hope you enjoyed today's episode. Check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcasts Spotify or wherever you listen to your favorite podcast

Paper vs. Electronic QMS implementation.
Finding an internal champion.
What is a no-code app?
How Andy scrapped the idea of building the app.
Validate in 4.0 working group.
What if part 11 doesn't exist?