How a quality assurance director freed up a week each month for continuous improvement using Qualio

New York-based Koneksa provides digital biomarker technologies for the remote capture of clinical trial data.

By unlocking deeper and more meaningful clinical information, Koneksa empowers its customers in the pharmaceutical and biotechnology sectors to make even faster, smarter and stronger decisions throughout their drug development and market strategies.

In 2020, with a legacy QMS unable to keep pace with growth plans, Koneksa went on the hunt for an integrated quality management software system and became Qualio customers.

We visited Director of Quality Assurance Stan Spagnuolo at Koneksa's Manhattan office in December 2021 to learn:

• The impact Qualio has had on his day-to-day work
• How Qualio removed a week of admin time from every single month
• How he's using that extra week to make his company even stronger

Qualio: What standards and regulations does Koneksa work to?

Stan: As we operate in a highly regulated industry, the pharmaceutical biotech world, we focus primarily on good clinical practice (GCP), ICH E6, the GDPR, and ISO 27001 from an information security perspective.

Koneksa provides wearable and biosensor technology to clinical trial providers to empower them with real-time patient data

Qualio: And what was it that kick-started your search for an electronic quality management system (eQMS)? 

Stan: When I came to Koneksa about a year and a half ago, we were a small company and growing very fast. We had a pretty decent QMS structure using, as I think most start-ups use, various different things like spreadsheets, calendars for reminders, and different things for training.

But our biggest concern at the time was: as we started to grow, the way we were managing our training was going to become untenable.

We were using a couple of different learning management systems, getting certificates, putting those into Google folders, and things of that nature. So we really wanted to make sure we had something that was all-inclusive and in one place.

And before we got Qualio implemented, we went through a very large revision of a number of different procedures.

It took us more time to pull all those documents in for training then it did actually making updates to the procedures!

So that was the biggest thing for us. 

We had a pretty decent QMS structure using, as I think most start-ups use, various different things like spreadsheets, calendars for reminders, and different things for training.

But our biggest concern at the time was: as we started to grow, the way we were managing our training was going to become untenable.

Qualio: So as you were evaluating different eQMS software vendors, what was it that made you choose Qualio over other options? 

Stan: We talked to five different vendors, including MasterControl and Veeva.

And Qualio stood out for a couple of reasons:

1) Qualio was starting to introduce something different to what the other ones were offering.

Most of these other eQMS systems require you to speak the system's language to do what you want to do or fit what you want to fit into it. With Qualio, it was pretty much out-of-the-box, get up and run with it. So it was very simple for us to implement.

2) We knew that Qualio was on a growth trend.

And we felt that it was going to be really good to grow with them as a partner, as opposed to someone that may have been a little bit more established at that point.

Instead of just feeding us what to do, Qualio said, "This is what we got. The sky's the limit. Come along with us."

So that was a big part of it. 

Koneksa's technology has ushered in a new and even more patient-centric approach to clinical trials, allowing Koneksa customers to make data-driven product development decisions with confidence

Qualio: And how long have you been using Qualio? 

Stan: At first, we were using it just within the quality team since the end of 2020. Then we went to the full implementation for everyone in mid-2021.

So for the rest of the company it's only been about six months, but since then I have to tell you this: folks that have been here for a while and have gone through all the old ways of training are saying, "this is fantastic! I've got to do it once, it's there, I know what I have to do, and when I'm done, I know that I'm done."

And for us, going through these training cycles, that's fantastic. You click it, you send it out, you get the reports back. You can chase people down just by looking at the reports and the dashboards, as opposed to using spreadsheets.

It's been a good experience so far.

Qualio: What are some of the things you like most about using Qualio? 

Stan: It's out-of-the-box and go!

You don't have to learn 'the language' to create certain things or have things fit in. It's very versatile, in the sense that anything we need to do we can just port into Qualio -  things like workflows for quality events and things of that nature. And this just opens up a whole new avenue for us to manage these type of things better.

Folks that have been here for a while and have gone through all of the old ways of training are saying, "this is fantastic!"

Qualio: What results are you seeing with Qualio? 

Stan: Training is always one of the most difficult things within a quality management system. It's something people are required to do, and they’re reluctant to do it. Some of the materials are a little dry. So it's just, “oh, I have to go and do this.”

By making the process easier and simplifying it in Qualio, we actually did see things getting done, rather than having to 'wrangle the cats', if you will, towards the end of that training period.

People are doing it now. And I think that the reason for that is just that it's simple to do. And it's more of an enjoyable situation than it was in the past. 

The other thing for us is really around the metrics that we can capture, especially with our quality events.

Again, in the past, it was a couple of different spreadsheets - and then you have to pull it all together and then provide some reporting. Now, I do measurable reports every month to management, and I can do it the same day because I can just pull that information right out.

Training is always one of the most difficult things within a quality management system. It's something people are required to do, and they’re reluctant to do it.

By making the process easier and simplifying it in Qualio... people are doing it now. And I think that the reason for that is just that it's simple to do. And it's more of an enjoyable situation than it was in the past. 

Qualio: So Qualio has saved you time?

Stan: I would say it's saved me a good week out of the month, especially in the training process. It was a lot of paperwork to manage and because we were growing so quickly, a lot of people and new hires coming through, I would definitely say about a week's worth of time. 

Qualio gives Stan at-a-glance visibility of the training status of the entire Koneksa team, while simplifying and accelerating the training process and maintaining compliance

Qualio: What are your quality plans for this upcoming year, using that extra week per month? And how will Qualio help you get there? 

Stan: We're looking to build out our quality event process a bit more and get those metrics even more meaningful.

With Qualio, one of the best things is the ability to 'tag' components of your QMS. So then you can get a lot more granular. We're going to start building out certain tags that'll help us.

I think most Qualio clients are product-based, and using tags for meeting their ISO requirements. But for us, it's more client-based and study-based. So where some clients could say, "I have Product A and Product B", we have Client A through X, and Study A through GG.

It's just that much work that we do. So to be able to tag those and get a little more granular on a quality event is going to help us tremendously. 

I would say Qualio has saved me a good week out of the month, especially in the training process.

Qualio: What would you recommend to other quality professionals who are struggling with the same problems you were and looking towards an eQMS?

Stan: Do your homework. Get a good understanding of what's out there. And really put together a plan as to what you want to do with your quality management system. 

Because unless you have a team of thousands, you're not going to do everything all at once.

Really take a look at things in phases and choose a tool that's going to help you work through them. We're, I think, a good testament to that. We came into it knowing the problem that we had to solve was training. And we were able to go in and implement that piece of it. Taking care of that opened up a lot of time for us to start working on other things. 

And for me, it's always a gut feel. Look at the type of people you're dealing with, from the sales cycle to when you start talking to folks on the technical side.

With Qualio, I had somebody from implementation come in during our sales cycle so I could get a feel for them, see what they know, ask them some hard questions and see what they come back with. Come up with some things that you think are unique to what you do, and ask a vendor those questions to see how they come back to you.

We had a really good experience when we were going through the sales cycle with Qualio.

We came into it knowing the problem that we had to solve was training. And we were able to go in and implement that piece of it. Taking care of that opened up a lot of time for us - so now we can start working on other things. 

Qualio: You mentioned Leo in the sales team before our interview. Any other shoutouts you’d like to give?

Stan: Janell in the customer success team was great, especially when we were getting up and running. She really helped us out a lot.

It was a really good experience dealing with those folks.

They made us feel like they wanted us to be part of Qualio, not a sales number. And that's a big plus. We felt like we were getting into a partnership with Qualio.

And we still feel that way.