KENX CSV and CSA University Wrap-Up, with James Northup

As we wrap up a very successful week at the highly attended KENX Computer Systems Validation and Software Assurance University conference in Philadelphia, PA, we are joined by James Northup from Tricentis. Dori Gonzalez-Acevedo sat down to discuss some key takeaways from the event for those unable to attend in person and recap some of the highlights from presentations promoting change in our industry, spanning CSV, gender equality and more.

Join us for this great conversation and don't forget to rate and subscribe wherever you listen to podcasts!

You can reach out to connect with James on LinkedIn here.

For more click on Don McPherson's work with Aspirational Masculinity and Alexander Prout and I Have the Right To

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a production of ProcellaRX

Transcript

Dori Gonzalez-Acevedo: 0:00

Welcome to the stage, James Northrup from tricentis. We are here on the last day of day three of connects CSV CSA University in Philadelphia.

Unknown: 0:13

Thank you for having me. Appreciate it. Yeah, it's been a it's been an awesome time here learning a bunch, getting some nice exposure to the updates that are coming around the industry and happy to be sitting down with you.

Dori Gonzalez-Acevedo: 0:21

Awesome. Thanks. I you know, I appreciate you taking the moment to do that. Because I find these recaps helpful to folks, for those that have been on the phone, it's still a hybrid event, it's trying to capture everything that's going on is hard for those that a remote. The people that are here in person actually have really long days too. So that's even more exhausting. And trying to summarize or kind of recap what it is what we've been doing. happens here

Unknown: 0:49

in Philadelphia, I can X what do we actually do here? Yeah, um, so we've been doing a bunch of events, or a bunch of meetings and sitting down and learning about, you know, presentations and whatnot. But I wanted to get your feedback on what you thought some of the key highlights were and takeaways from the CSA CSB connects presentation in 2022.

Dori Gonzalez-Acevedo: 1:08

That's great, because I think what was most exciting to me, what we saw was, first attendance was huge and person, right. So for those on the phone or listening in, this was the largest in person event that connects had this year, very well attended also virtually in addition to that, and part of that I see as the course of 2022 was more participation, more wanting to reach out and understand what's going on. At the conference itself, lots of questions about the draft guidance that came out. We had Cisco and members of his team here. And part of that conversation continues to be what do we do with it?

Unknown: 1:51

How do we move forward? And make sense of it?

Dori Gonzalez-Acevedo: 1:55

Make sense that what am I doing, quote unquote, right or wrong? And I think so part of the that's kind of been the trend in 2022, asking a lot of questions. And so what I think I'm we're left leaving here, or at least my hope, of what we're leaving here with is a sense of question asking is a good thing.

Unknown: 2:17

Yeah, absolutely. And I think just to kind of double down on that, you know, where it connects and the quality of participant that's here is different than other conferences I've been to, it's very specific. If you're in the CSA, CSP space, and you're not at clinics. You know, it's something you should definitely come out to and get a better experience for. So I guess, speaking of asking the right questions, how do you feel that that it's being received? How do you feel that the transition to CSA and CSV is being adopted, I guess, throughout the industry, or at least as of now,

Dori Gonzalez-Acevedo: 2:53

yeah. So interesting in the words that you chose, because so one of the things we did differently connects this year was we also brought as our keynote speakers, Don McPherson and Alex Prout here to talk about gender equality. Thank you. And now, I that also was extremely well received. And the feedback we got was great, as is a conversation that needs to be had. And I draw parallels of that conversation around how and what bringing more equality to the rooms is around the concept of change, right? Like, we in the industry here, in some ways are broken. And we need to do some reparations. Sure. So just around, you know, women's rights and equality, we reparations and, and leveling the table table needs to happen. You want people to the conversation just in general. Exactly. Bringing more people to conversations. So in because we want to move the industry forward, we need to have some of these hard conversations. So what works, what doesn't work? What is risk? What is not risky? You know, and, and how to cultivate that in a way to hear everyone's perspectives at the table.

Unknown: 4:07

Exactly. And I mean, at the end of the day, it's about having the actual conversations, whether it's, it's business or personal relationships, or however it is, you have to have the conversation, you have to explore it, and it can't be one sided. It has to be an actual given taken. You're trying to find a consensus at the end of the day, what works best for everyone included in that conversation. Yeah,

Dori Gonzalez-Acevedo: 4:25

you're 100% Right. And I think that's, I know, part of your style, as well as always to get to know the other play, and I do that, as you know, as we've also co sold and help folks out is it's there's no one size fits all for anything. 100% right. And it's really trying to navigate those conversations so that the true understanding of intended use and business use cases and and even the team makeups that folks have matter and terms of what business processes you're going to put in place or not put in place? Or what tools you're going to purchase or not purchase? Or what skill sets does your people need now, and moving forward versus what they had before?

Unknown: 5:13

What do you say? It's what people process,

Dori Gonzalez-Acevedo: 5:15

technology, and most importantly, culture? Absolutely. And so a lot of the conversations are here around the room this week is around changing that culture. And so there's some fundamental things that we need to do to do that.

Unknown: 5:32

Absolutely. So as we kind of transition into 2023, from 2022. And, you know, what are some of the things that are exciting you from, from an industry standpoint, from an operational standpoint, from an interpersonal relationship standpoint? What are kind of what are you looking for on the horizon?

Dori Gonzalez-Acevedo: 5:49

So inspiring, regular routine conversations with accountability. So one of the workshops yesterday, and women leading validation that we did was really truly to try to find what it is for our, our personal goals and objectives are, right, and how that translates to our teams or their larger parts that we influence on a day to day basis. And then the last ask is what is our organizations need to do to help us get there? And so for as if you're an individual contributor, as part of a team, you might need to figure out how to ask for what you want to do. And you've heard these cool things that connects and I want to try this, and I want to try that, rather than having this big, heaviness around, oh, we have to do this big organizational change management thing. We're talking about like small, let's try something different. Short,

Unknown: 6:41

how do you think that's the best way to approach that conversation with your senior leadership? If you're trying to just move the needle a tiny bit, right, you're not trying to revolutionize how you're going about everything, but how do you think is the best way to start that conversation?

Dori Gonzalez-Acevedo: 6:51

That's great. I think the bottom line is just coming back from this conference and asking for a meeting and saying, I'm really excited about what I heard. Make it short, simple, two or three things and what is the ask that you have of your boss or supervisor, whoever to be able to say, can I put you in connection to so and so? Or can we bring in someone so to educate whatever that is? It's a simple ask, most of us just don't ask.

Unknown: 7:18

Yeah, I mean, I think it's funny. Um, you know, the people here at Connects are normally a little more leaning into the industry leaning into change, leaning into the sort of things. The industry as a whole, though, I'd say, or not leaning into these things and stuff like that. So the champions that are at Connects need to be champions in their internal business as well, because 20 years has gone by and no one's ever come to again, next, you know, doing computer systems validation, right? It's right. It's just starting that conversation. Yeah. So what do you think are the big changes from an organizational standpoint, with med device pharmaceutical companies in the CSP? Space? I guess?

Dori Gonzalez-Acevedo: 7:53

That's a That's a good question. Because I think it when folks are starting to now implement more advanced technologies in terms of AI and machine learning, and companies that had not been developing software as a medical device previously, that are that are starting to because of the necessity of the change of the industry, in general, I think we have a very good opportunity to spread our wings a little bit, be a little bit more flexible, to get to the rapidness of the the amount of release and change that we're actually practically seeing in the world. So, you know, historically, I think we were seeing, you know, oh, maybe a major upgrade every other year or something like that. Right. But what we're actually seeing in the software as medical device and medical device area is, is those type software changes are happening weekly. Absolutely. So it's a shift from this big, you know, kind of corporate enterprise level release management once a quarter or once every half year,

Unknown: 8:59

once a quarter. That's aggressive. That's typical, though.

Dori Gonzalez-Acevedo: 9:03

So once a quarter, that's sap that shows, right so there is rapid deployments in it, but we're actually seeing shorter and shorter release cycles. And in order to get to shorter, shorter release cycles, you have to fundamentally change your CSP process into a more agile methodology.

Unknown: 9:20

So do you think now in my time working with you and me, I've heard CSA, I've heard the conversations about shifting and testing first and more often. Do you think we're at the precipice yet where we're actually going to get some change? Or do you think people are D fearing this concept a little bit or so?

Dori Gonzalez-Acevedo: 9:37

It's interesting. That was another topic down and I've shared some thoughts around around this concept of fear. And it's not I don't think we have to get rid of the fear. Yeah, I think we need to have a healthy respect of what that fear is, and understand the obstacles and mindsets that have left us stuck in that Fear, rather than giving us an opportunity to try a new technique or try a new tool, and I think I've spoken this in the past on podcast, but you know, being a scientist is is part of constantly questioning things for me, and that's who I am. But I think also for us as humans, we've forgotten to be curious here.

Unknown: 10:21

Yeah, that was the one thing curious, cautious, you know, methodical about your approach. And test it? You know, like you said, you're a scientist, right? That's the whole entire foundation is testing does it work?

Dori Gonzalez-Acevedo: 10:32

So there's a fundamental part. And I think Donna was even talking about, like, you know, from young men to adult men, we've missed out the opportunity for the fun piece. We've lost the fun, we've lost the curiosity, we've lost the playfulness. Sure. And we you know, so if we can do that, and translate that to all these new techniques that we heard about for the last three days, try one pick one out doesn't have to be all of them, just one to try something new.

Unknown: 11:01

And it doesn't have to be something that is potentially could have these massive ramifications, you don't that you know, you can implement something on a small scale, and then grow it from there and see that it actually works. So as far as to go back to Dan's presentation, and then Alex, you know, so what happens from there? Right. So I know that when the conversation ended, it was definitely got some awesome feedback. But what are the next steps for people that want to hear more about it? And, you know, continue to expand this conversation?

Dori Gonzalez-Acevedo: 11:29

Yeah. So anyone that is wanting to bring in Don and Alex into their organization to have these conversations around gender equality, we can set up meetings and schedules for that's the easy ask. I think the the big ask is also within our connects community to start advancing other alliances in 2023. So to expand, that is one of the top agenda items for us. I believe

Unknown: 11:58

there's a pledge you can take online, there's a pledge for I have a right

Dori Gonzalez-Acevedo: 12:01

to you can take online. And so you can reach out to that I have I have a right to.org And reach across the aisle get to know someone, these three days have been such rich conversations. Yeah. Have you been having those?

Unknown: 12:19

Absolutely. I mean, just across the board, whether it's, you know, companies that are, you know, full blown, you know, either using our solutions, or automated from their companies that are on paper, or, you know, just been, you've been able to just talk, you know, without having the stigma of, hey, this guy's in sales, and he's going to try and sell you something, it's like, just talk, you know, at the end of the day, this is such a complex thing that we're working through. So you actually have to lay options on the table, you have to discuss and kind of find out the best way of what might make sense for you. And it might be a bimodal approach. It might be implementing different methodologies or whatever it might be, but until you kind of kick the tires, how you're just going to do what you know best. Right? Yeah. So. So as we kind of wrap up kennix. And what's on the docket for you leading into the new year? Obviously, we have holidays coming in, but Priscilla Rex is off and running right now. So

Dori Gonzalez-Acevedo: 13:16

yeah, so we're planning our schedules are talking schedules or road trip shows, for 2023. As Prasad works, we are offering supply of wide variety things to support our partners, like yourself as well, because having these conversations often you need that facilitator to do that, right. And so bridging the gap of terminology across the QA department versus the IT department versus the business unit. And so I'm really excited about that, and bringing those conversations to the table in 2020.

Unknown: 13:49

So let's say that I'm somebody that is, you know, listening to the podcast, I'm interested in hearing more and understanding how I could potentially, you know, implement some new things in my business processes. But I don't necessarily come mechanics. I don't necessarily dive in what are some ways that I can kind of expose myself to the new thinking and new processes and methodologies? Or what would you say would be a good way to kind of dip my toe in? I guess?

Dori Gonzalez-Acevedo: 14:11

That's good. There's lots of ways to do that. So there's, not only is there connects, there's ISP II is a great organization to do that. And there's software quality assurance as QA that is there. There's several of those sorts of networking things. The FDA also puts out a lot of position papers on their website. And they are doing running more webinars themselves as they are educating and training their investigators. So I think that's really awesome. I know Cisco and his team are willing to come into organizations and give thing talks. So it's kind of using a multi prong approach to get those things there is. In addition, there's online communities too, that LinkedIn is a great one. way to do that we have women in CSV, which is a private LinkedIn group that we've grown over, I think it's we're now over at a women within like six or seven years, and which is outstanding, the women leading validation group within connects is the other but there's others out there to engaging in dialogue. And online, you'll see a lot of questions in some of the big groups. There's like GAMP groups, and there's other groups, which are like, 1000s of people belong to these groups and posing questions or, or pondering things

Unknown: 15:36

this community is open. Like, I don't know, if people understand that, you know, you can ask a question. The whole process is very opinion based in a certain way. But you can ask questions, and people will give you their honest feedback about how they're going about this, how they're accomplishing these sorts of things. And even to that point, I mean, I have a ton of experience talking with Cisco, and specifically the FDA, but to see them sitting front row, answering questions, speaking with Louis and, and so on, and so forth. And really interjecting based on how they intended this to be written and taken. So yeah, my takeaway was, the FDA is ready to have the conversation they want

Dori Gonzalez-Acevedo: 16:15

to they have been and so it's, they're always the position is to be collaborative. And so I get back to what we were talking about a little bit ago, it's the ask, you just need to ask. And often, that asked seems more terrifying, because you don't want to know what the what the what the response is, or maybe you already know what the response is, but you haven't yet gotten your organization to get there. And so it seems like a really hard thing to overcome. But incremental, small changes, right? Like, really do have that ripple effect, right? You can always do the big, dropping the big stone in the pool and go at full full force. But that also has a different ripple effect. And then how to support that. But when it comes down to time is our finite thing. And with that time is is also the limit of our resources, and our people capital. And we need to invest more in our people.

Unknown: 17:18

Absolutely. I mean, in the companies that are sending their people here, to this conference and conferences, I like to sit in on these 45 minute sessions that we're, you know, we're talking with some of the biggest companies in the world that are exposing how they have transformed their processes, how they approach the documentation and how they approach their their methodologies. And then chiming in and dispelling myths or whatever it might be, it's been really eye opening for me in general, it's good to get a feel for that. But kudos to companies that have people out here,

Dori Gonzalez-Acevedo: 17:49

could you would you mind reflecting a little bit on Don and Alex's talk and how that impacted you? Yeah, man.

Unknown: 17:56

Yeah, I mean, so, you know, when I look around, and I'm in rooms with people, and throughout my whole entire life, it's been a lot of man's work for the majority. Right. And, you know, I don't necessarily have the experience with, you know, potentially, you know, excluding people just based on their gender in a certain way, but I can feel it, you know, I can look around and see it, and when you've, it's one of those things, when you notice something, it's hard to not notice something. So, yeah, I thought it was I thought it was genuine. I thought Alex spoke about his daughter and the experiences that she faced, Don being, you know, a former college star and professional athlete, you know, talking about masculinity and how to who you are as a person. It was, yeah, it was, it was definitely powerful. It was an awesome conversation. And, you know, I think it needs to happen more, you know, make this more inclusive in general. There's a lot of there's a lot of bright ladies here. I mean, I'm turning around having conversations, and these people have been in the industry for 2030 years, and they have a lot to say, and it's valuable. So just need to consistently have that conversation and ask the right questions and whatever scenario you're in. Yeah.

Dori Gonzalez-Acevedo: 19:12

Okay, well, I know we're have to break down. start wrapping up. I appreciate your time, James,

Unknown: 19:17

thank you for having me. Appreciate it. Yeah.

Dori Gonzalez-Acevedo: 19:19

Always good to see you in person. Definitely. Uh, hopefully in 2023. We'll get to see a lot more people in person. Oh,

Unknown: 19:25

yeah. I'm all for the events. Let's get out. Let's talk. Let's ask questions and keep moving forward. Awesome. Thanks for having me. Thanks.