Rohit Tyagi: 0:00

In some ways, I understand what she's saying. out, I was one of the jaded consultants like okay, here preach this to three years, and then we'll be back to where we

Harsh Thakkar: 0:21

[Podcast Intro Message] All right, we're live. Thank you for joining us Rohit and thank platform. Today on the Life Sciences 360 podcast, we have life sciences companies with IT projects, quality, and lab

Rohit Tyagi: 1:04

Thank you, Harsh. Thanks for having me. And

Harsh Thakkar: 1:09

Yeah, so I know we connected because we have a Pennsylvania, I know you live in Collegeville, Pennsylvania starting Sagax team?

Rohit Tyagi: 1:28

Well, yeah, it's, you know, it's a long version, think in my entire ca reer, I only had one full time job. And mid sized biotech space. And that really interested me leading teams. And in general, I saw that there was a lot of you know, I wanted to bring some changes to how consulting

Harsh Thakkar: 2:08

And as you're, as you're doing this, with clients,

Rohit Tyagi: 2:16

We started in 2018. At the business before that, I

Harsh Thakkar: 2:20

Okay. So like four or five years, you're validation or IT implementations? What have you

Rohit Tyagi: 2:35

Yeah, well, okay. So, you know, validation is our some of the common mistakes, which are well known, is just what you know, what you're really trying to do. And then then you start treating everything with the same in. And I'm sure we're gonna get into that. But those were the companies don't even understand what exactly validation means,

Harsh Thakkar: 3:27

That's, that's a good way of putting it i like i state and the event is, you said that people don't understand the think is like the biggest misconception, like, what do you different in different companies, how has your

Rohit Tyagi: 3:59

One of the common ones, which, which I was just fact that they, you will get a call, I want this statistical earth over there. And when you get into it, that's when they Right? So it's, it's interesting, because at the same taking months and months and months, but at the same time, tool has to be validated. You know, just because it's a important to define what the intended use is, what are the the data gonna be used for that. So there's a lot of things to I'm coming to your answers, validation is not simply largest misconception is that a lot of people who are not in the

Harsh Thakkar: 5:22

Right, it's it's definitely way more than I'm curious to know, and again, this is just so I can learn like you said, you know, somebody will say, Hey, I have a you go in. Good consultants always go in with like an open max value, right? That's what a good consultant thinks. When you validation processes? Or just the general understanding of company or that team thinks about validation?

Rohit Tyagi: 6:23

Yeah. So that's a good question. We actually are the main CSV SOP, right, like a validation procedure or policy, management procedure. So those two are pretty critical to if you want to make changes to that, that's a battle that I specific task. But that's where a good consultant I think can this project, but you may want to consider revising a few certain things that we could probably leverage either from a the vendor had already executed some test scripts, but you never of stuff a couple of years ago. But in small companies, you see but you will see this interesting cases that you've another job left the company now that thing just got is an information? I think a skilled consultant can really leverage

Harsh Thakkar: 8:01

Right? Yeah. And smaller companies are trying to on. It has its plus and minuses. I've worked in many small to work with people more closely. Versus if you're because half of them are in other timezone and whatnot. So validation regulations, right. And the reason why I said this, something came up about CSA, and I said, Yeah, have you read asked her? And she said, I've been doing CSA for 20 years. And new. So what is your take on CSA and in general, the concept

Rohit Tyagi: 9:18

So in some ways, I understand what she's saying when the initially CSA initiative came out, I was one different bottle. You know, it's gonna, they're gonna, you know, but, but then I saw some companies really making an you know what, as an industry leader, but it's our the FDA, first of all has openly come out and say that, look, we secondly, they've given some framework initially, it was very 5 categories, but they're so I mean, up to people's where I feel you can save time is the whole unscripted testing You can say, risk based, but when it came time to doing the Because, you know, we've spent three months might as well spend So I think that's where I do agree with her. But I think the quality and focusing on critical thinking upfront, can I go right. And I was sitting with some engineers from CAI, and you we're sharing here. Right? It's, this has been we've been talking just that our industry loves paperwork so much that soon step two think that we think this and then that will become funny statement. But I think there's a lot of challenges to moving from one company to the other. Like if you initiated all propagated towards throughout the company? No, you're not little different ideas. So that's where I think the

Harsh Thakkar: 12:24

Yeah, and as you were explaining, this reminded further. And I kind of agree with what you were saying, expected for that? We haven't seen that from past FDA general, there's a lot of gray area, like, even if you talk everyone in that room understands what part 11 is, So even that guidance, that regulation that has been around working on projects with either your team consultants that Because everyone can interpret the word written in a regulation If you are in a very challenging conversation around validation

Rohit Tyagi: 13:51

You know, fortunately, we have not had not understand what an audit trail is. And they were they not an audit trail, for example, right. Keeping a log of what is related to data. And, again, you know, 21 CFR Part 11, also GXP. through any definition, right. So so they were they consultant, you have been given it a little bit of a position of think as soon as we are able to establish that we know what companies. I mean, you have experts who've been there for difficult situation, I think you just have to be like, just like understand personalities, and then make sure that the the work you want it to, it's okay, but at least you're not butting How have you how have you handled it?

Harsh Thakkar: 15:34

Yeah, for what what I think has happened in my I have for you, as well. So it's, it's, I'm glad you brought say, I'm working on a project for I don't know, Salesforce, or life sciences in the past. But he's worked at some really big So great, we have a really good person on the team. But the is really, really like, that person has to put a lot of time. to have these discussions, they're immediately faced with you go to a room, and five people are telling you like five I've seen is maybe I've just been part of those teams, where understanding, or they didn't have a good structure, like you base, or whatever, for new people to learn about part 11 through the document and sign and say you read and understood trying to find out what these things mean. So what I wanted to domain knowledge, but they have great skills? You can use them them out? Because these people need help? Oh, yeah. haven't

Rohit Tyagi: 17:55

Absolutely. I think we should definitely hire them. coding in like three to four months? Probably not. But can I our industry in this field, right? It's not theoretical, right? Over different scenarios, different different types of like, wow, okay, you know what, that's why we should do this usually instruments software, the, you know, they, they're were just making a, something that just runs in a test, no situations. But you know, I am definitely a big proponent of sometimes people who are not very technically skilled, don't validation specialist on a project. And this guy by trade Val plans, right, Harsh, they were so laborious ly long, with something or for a IRT system to output something so when I you know, some things we don't have to get into it because this so hard for him to do that job that eventually he just moved those things, my goodness, man I really admired. And I loved to learn, unlearn certain things and, you know, not apply the

Harsh Thakkar: 20:25

It's very, like you said, you know, you were 20 years, and it is boring even today. Like, I won't name any and I'm like, how the heck do you review this? Like? I'm like, you review this? Like, give me something, highlight something show can figure out how to make technical documentation a little some that have nothing like two, three pages. And I've seen because as a quality reviewer, I get frustrated every time I get it back, or this is not enough. Give me more.

Rohit Tyagi: 21:44

Exactly. And sometimes, like you see, an point. You know, one thing I do want to say about the one advice years, right. So my time is mostly in client meetings, them, right. And soon, I'm going to be walking away from that as until you run your own company, you don't realize how much critical, right? And the one thing that I wish, because of the things that I focus on is remembering the inherent risk of forget the overall risk of the application, sometimes the whole lost into a functionality, and this functionality has a complex start testing the heck of it, start validating the heck out of mistake, what you should be focused on if there is a and and what are the actions needed to be taken to correct not losing sight of that, where I feel like sometimes in our don't find it to be that high value for the client.

Harsh Thakkar: 23:48

Right? Right. And and especially, you know, with which application you're using. If you have to do the initial analysis every time the software provider does an update after doing at least two or three change controls every year? manage these three, four cycles every year?

Rohit Tyagi: 24:29

Absolutely. Absolutely. So it's not my idea. of that as genius? Right? You don't have to keep opening just define that change control the different release different do and then you don't have to route it for approval you that I know some companies have already been doing it, which is everything thoroughly. So leverage that. And always keep a another key thing I want to talk about is the main config file, you put it in box, maybe put it in a document management system. currently have turned on, and if any of yours are being impacted, fine. So 99% of times revalidation is not required or TrackWise that some company is using, maybe that might

Harsh Thakkar: 25:59

Yeah, when you were talking about the change like a parent and a child change control. So they would have the release under that would have their own child change controls. can have one open and do everything under that. Or you but I learned from, you know, other consultants on projects.

Rohit Tyagi: 26:42

I like that. Also, I've seen the parent child, some the overall world, or they could just be a change for maybe the full. And then let's say if the change is a whole vault based, company might be using. But I can see them using it the same some other tool, how they configure it.

Harsh Thakkar: 27:22

In right when you were talking about leveraging people in the industry, somebody's mentioned automated across any automated testing tools that can be done like system doesn't break? It's still questionable if do you need to know if you've come across any automated testing tools for

Rohit Tyagi: 28:04

Also, you know, I know you had once posted about And it works well with most of the SaaS systems, especially test has been used a lot in our industry.

Harsh Thakkar: 28:24

HP ALM is another one, but it

Rohit Tyagi: 28:27

is a VLM. And there's UTCs, their automation

Harsh Thakkar: 28:32

Right? I don't exactly know, like, HP has gone Management. And I know there are some, there's automated features

Rohit Tyagi: 28:47

I they I don't know, they're now called it's digitizes your whole requirements, trace matrix test Interactives Winrunner, when run and LoadRunner. So Winrunner Winrunner, after 20 years, its name has changed to I think UTC. for load testing, that that system is more for like big pharma big right? We never had such heavy applications to test. straightforward. Agreed. Yeah,

Harsh Thakkar: 29:41

That's a big opportunity, especially with the area that I'm more excited to work in and just see what kind automated testing capabilities, because that's just going to because SaaS tools are not going anywhere. They're going to be

Rohit Tyagi: 30:13

To kind of second or piggyback off that a lot of manually retest everything. I also see that okay, there is no to spend in but if you did, have those automated test suites you're done. So that value is there. Yeah, agreed.

Harsh Thakkar: 30:42

I want to talk to you about hiring, because that's in the growing growth phase. haven't finished the first year your top trait that you look for when hiring someone? And it's?

Rohit Tyagi: 31:10

That's a great question. Man. Hiring is the company and be able to integrate, assimilate in your why hiring becomes harder. But the more business owners that both, you know, you have to be quick. But what I would say is recruiting, first thing is I've always valued communication a to so much detail that I didn't ask for? So I'm really looking lot of things matter, right? Unfortunately, harsh, there's somebody who who identifies with our values. So we have five fit, I can only tell after I've hired them. And after they've exam, we've given them if not an exam, but an email that, hey, personal professional life, you've demonstrated those and critical part of your company. Yeah.

Harsh Thakkar: 32:52

And for me that for me, it has been something the biggest trait has just been finding someone that is willing of the company, we're still pretty small. I can't be there give you an answer, you can find it online, you can find it on, right, whatever it is, right, you can find the answers. But searching, you may be able to find the answer. And you may be So, for me, it has always been, I always ask people, hey, if Make an attempt, you know, see what you can find. If you're not that has been something that I always look for is are you going Like, go do this? Go do that? Yeah.

Rohit Tyagi: 34:23

So one of our five values is continuous learning. process. But within 90 days, it's very clear if if people are can just learn you know, I was just I wasn't I was traveling to ChatGPT and I just learned so much more about my industry the thread and just posted it somewhere because it was pretty

Harsh Thakkar: 35:11

Yeah, yeah. ChatGPT is, is great. But there the confidence it has in giving the answer when it's not right. tool has in telling you you should do this. It sounds like grain of salt. It's great tool for brainstorming. But if you're it's all it's a slippery slope, it could take you down a

Rohit Tyagi: 36:03

You got to have the right. I saw somebody's post And but I didn't know that. It's called prompting, but that's building up, you know, building up on one sentence to the other chatting with someone? You know?

Harsh Thakkar: 36:29

Yeah, it's it's a, it's a groundbreaking know what's going to happen with it in the next 5-10 years. So

Rohit Tyagi: 36:51

2023 is the year man, we had very good growth are one is quality and compliance within which you services that fit in that. And then we have lab informatics, adding looking to add a cybersecurity part as a service. a lot of smaller companies is that they need help with just Google, majority of them still have Microsoft, but they're not available. So we're looking to add that as a small service just you know, may not have a lot of funds available, and they may there'll be there but for now, they just need to make use of don't also have to focus or invest too much in regulations that as a need. So we're growing in that as well. So those are Let's see if that happened this year. Yeah. But But yeah, that's

Harsh Thakkar: 38:30

So it's it's really you know, as a, as a your business is like having a second child, you know, you're about, yeah, you know, project or anything. It's hard to shut like to do to unplug and disconnect from business and

Rohit Tyagi: 39:05

We are also in growth stage right? We we are love doing it. That's why you know, every minute you do it, the you know,

Harsh Thakkar: 39:25

Happy Birthday.

Rohit Tyagi: 39:26

So he's big into football. So for me spending My younger one is 11 and he has his own interests so we have a wish I was more like into hiking or biking or just you know doing

Harsh Thakkar: 39:56

I got I wouldn't say I got into it. but I had you? amazing outdoors, you know, for hiking and going to like Mount much everyone in Seattle was big outdoor person. And that's where hikes or you're going to see a lake or whatever. And you have three hours, and I have no cell phone service, like I can't even you just like, yeah, forces you to just like, connect, stop did do a lot of outdoor stuff. But then, since I had my son, we'll try to go we go for walks and stuff.

Rohit Tyagi: 41:07

But how old is he?

Harsh Thakkar: 41:09

He's two years, now. He turned..

Rohit Tyagi: 41:11

Yeah. Okay. Great age, man. Fantastic age.

Harsh Thakkar: 41:14

Yeah, so I spend a lot of time with him. Just outdoors. He likes to now he's starting to go on his bike, and like that. Maybe in the future. Yeah.

Rohit Tyagi: 41:34

Biking, I think is a great thing to do. I mean, could just bike and bike and bike. Maybe I'll pick that up. There's thoughts going on. And I think it shouldn't be like that, think it's really, yeah. But great man,

Harsh Thakkar: 42:01

Where where can people find you or connect with

Rohit Tyagi: 42:09

Absolutely. So my number one place is LinkedIn. drop, you know, somewhere on this, okay, and a Facebook page, sagaxteam.com. If you click the Contact Us button, you know, all we'll be happy to happy to get connected with you guys.

Harsh Thakkar: 42:40

All right, any final thoughts you want to add?

Rohit Tyagi: 42:44

I would just say that, you know, if you are learn a lot. If you're someone who's looking to start a supporting that the whole industry supporting that. And

Harsh Thakkar: 43:10

Yeah, yeah, it's a great industry to work in. jobs, everything. It's just a great industry. The thing I love to get that if you're just in a tech company, or you're just in always learning new things. And that's why I just love about non tech, doesn't matter, you're going to have fun. This industry

Rohit Tyagi: 43:58

Absolutely. Well, thank you so much.

Harsh Thakkar: 44:01

Yeah, thank you Rohit really enjoyed this that come up.

Rohit Tyagi: 44:09

Same here, man, keep posting. I love your stuff.

Harsh Thakkar: 44:12

Yeah, thank you. same here I wish you all the[Podcast Outro message]