Announcer 0:05

Welcome to Measuring Up, Thinking Out Loud, featuring news and information from Testo, your consultative resource for precision measurement technology and digital solutions, serving the pharmaceutical, industrial, and allied industries worldwide.

Bill White 0:23

Hi again, it's Bill White with the Testo Information Network, and today we're on again. Thank you so much in advance, Jim. Jim Bacon, president and founder of Stay Cool Logistics. So, Jim's company, a consulting company. He's a consultant, an expert in the business of cold chain logistics with many years of experience. Welcome back, Jim, to the Testo Information Network. Hey, thanks a lot, Bill. Appreciate you having me. Thanks. And today we're going to talk about the cloud and the cloud solution that Testo has developed that they refer to as Severus One. But it's Severus One, but with uh an added value. So let's just get right into it. What is Severus One cloud solution? What is that and why is it going to be so beneficial to the market?

SPEAKER_02 1:12

Well, yeah, I think that the kind of added feature that Testo is is introducing is called the freeze version. You know, offline we were talking a little bit about some examples of introducing updates in a higher frequency fashion that creates some data integrity issues or has the potential to create data integrity issues, and what the freeze version campaign for Severus One is going to really solidify data integrity. And when I think about data integrity, I think about, you know, assurance, trustworthiness, compliant atmosphere or environment, and really risk avoidance and mitigation. It creates that notion of stability for the client where they can plan ahead when and if they're going to do a validation. So that's really what the bottom line is for Severus One.

Bill White 2:04

Jim, the ability to pause the need for validation for three years is an enormous economic benefit to a customer that adopts the Testo program. Where are the areas where this uh these customers are going to save so much money and time?

unknown 2:21

Yeah.

SPEAKER_02 2:21

So when I first learned about this, I kind of think of it in a in a way it's a forward-looking strategy that you can incorporate in really the strategic plan of an organization. A lot of organizations have a validation master plan, and this validation master plan can become part of that strategic plan, becomes really part of the operating plan for the organization. So it creates some predictability and stability from an economics point of view, as well as an assurance from a data integrity issue. Also, it provides some protection, you know, or audit proofing for the organization because the organization understands and knows that Testo will support this particular version for a period of time, in this case, three years, and it really creates that risk aversion that can often occur when an unplanned change occurs.

Bill White 3:16

Jim, what about companies that are now adopting and approving and feeling more comfortable with the cloud concept, wherein uh before that wasn't always the case? Uh, how has Testo made that leap? And what do customers need to ask a company like Testo about the uh validity of the information, the ownership of the information, and the ability to manage it after the fact?

SPEAKER_02 3:44

Sure. You know, what I particularly like about Severus One and provides some level of comfort for um the client, you know, Testo Severus One has built-in layers of redundancy, right? So although it relies on the cloud to transmit that data, there are redundant mechanisms in place, you know, for continuity of recording that data, even in the event of uh an eruption in the cloud. It does provide the capability of SMS or text alerts if needed in the event of some kind of interruption or excursion. So this multi-layered redundancy, you know, really provides that level of security that uh clients are really looking for.

Bill White 4:28

Okay, we'll be back with Jim Bacon right after this. All right, we're back with Jim Bacon. Jim is a consultant to the industry, an expert in the cold chain and many other things. Jim, you're reading some literature that really does promote the concept and articulate the uh different permutations of cloud-based monitoring and all. What about that?

SPEAKER_02 4:57

Yeah, I recently read a white paper that Testo published, and it really dealt with what they refer to as stable validation and audit readiness. And I really like a question that was posed in the white paper, and it goes something like this: how can compliance validation and flexibility be brought into alignment? This really ties into a recent blog that I published on on LinkedIn uh just a month or so ago about the core team approach. And in there, I talk about flexible discipline. So I really kind of, when I was reading this, I really kind of saw that direct connection. So what I was referring to is that you know, you've got flexibility in how you approach a particular situation, whether it's environmental monitoring, a particular shipping lane, a temperature you're trying to control. So you're trying to create the best solution that fits that particular situation. Where discipline comes into play is that you're needing to ensure that your planning and your controls ensure a compliant and validated approach. So what my response to that was there's a balance. So you're introducing risk management into the equation and continuous improvements, and those viewpoints or those concepts will ultimately create a compliant and validated solution for yourselves that you've been able to adjust specific to your situation. And that's what I like. You know, this is where um Testo Severis introduced that flexibility.

Bill White 6:35

And as an industry consultant, you work with uh so many different companies and so many different vendors of services that may be somewhat analogous to Testo, but without that benefit of that great Severus that frees function. What should a customer be asking you if you're brought in as a consultant and they want to do this, they want to do the cloud finally after trying to do it internally for so many years. They want to do this. What do they need to be asking you, Jim?

SPEAKER_02 7:06

Well, ultimately, the you know, one of the first questions that comes out is how can I create a cost-effective solution for my organization? And, you know, my response is always, although cost is critically important, you don't want the decision to be a transactional cost decision. You want it to be well thought out, strategic in nature, ensuring that you're compliant at the end of the day. Because ultimately, what you're trying to do, whether it's environmental monitoring or shipping, is you're trying to provide data integrity. So the data that's collected is trustworthy. And you're also protecting the integrity of the product. If you can avoid or mitigate any risk of loss of the product, that in itself helps to provide savings or potential savings or avoided expenses in product waste. So don't look for a cheap solution. Look for a solution that is really going to work for you and really at the end of the day is going to provide that product integrity and ultimately patient safety.

Bill White 8:11

Safety, key word there. We'll be back with Jim Bacon right after this.

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Bill White 8:26

Jim, as we're talking about Testo and talking about cloud solutions in general, we need to talk about one of the initiatives that you've established. That's the cold chain navigator. Can you tell us about this? It's pretty interesting what you've done as an outgrowth of state cool logistics.

SPEAKER_02 8:45

Thanks for mentioning that, Bill. I've had the pleasure of collaborating with a former cold chain colleague of mine, Esther Vandenbosch. And she has created what is called the Cold Chain Navigator. And it's really an automated platform where cold chain solution providers or suppliers can partner with the cold chain navigator through a qualification process that takes a look at quality management systems, manufacturing controls, validation, reporting, even sustainability, standing in the in the environment, and provides this portal of these suppliers and also includes what we call ecosystem partners. So these are device monitoring and environmental and monitoring organizations like Testo. And, you know, how does it benefit a healthcare user? So a healthcare user would be a could be a clinical trial company, could be a manufacturing organization, any organization that's looking to define what their cold chain uh solutions are going to look like. And they can create or enter user requirements into this platform. And then for a small fee, it will generate the three closest recommendations, if you will, for a solution. So it's really matching the user requirements to the capabilities and the qualifications of these supplier and ecosystem partners. And then the healthcare user can then contact these suppliers and partners directly to negotiate a plan going forward. So I'm really excited to be part of that. I'm going to be the North American representative for this initiative and really excited to bring on some partners so that we can, you know, provide this uh really economic, think of it as an economical RFI for healthcare users to use as opposed to um a lengthy, burdening process where they need to contact each of the suppliers.

Bill White 10:35

So it sounds like you're asking all the right questions or helping a customer step through the process by putting these questions forward and then simplifying it uh with respect to where they can take the dialogue after that.

SPEAKER_02 10:49

That's correct. And really the key here is that it's a neutral platform. So although we take the partners through a qualification process to initially vet them and approve them, once the user identifies their user requirements, uh they get an output of three possible partners that they can associate with. It's really up to the solution partners to then go through the sales cycle with that healthcare user.

Bill White 11:14

Okay. Sounds like a great idea and one that's based on many, many years of experience and uh a lot of stories out in the field, I suppose.

SPEAKER_02 11:24

Exactly. Exactly.

Bill White 11:25

Yes. There's nothing like uh being out there doing the work for uh the better part of your career, is there?

SPEAKER_02 11:32

That's right. I've had the distinct honor to be in this business for almost 30 years or more, and I've talked to and met a lot of people in the manufacturing arena, in the supply arena, been able to review and advise on different technologies over the years. But here's an interesting fact. I I read an article a couple of weeks ago, and it really resonated with me that still today, you know, over the past year, $35 billion of product, it's estimated, has been wasted because of broken cold chains, whether they're in a storage facility or whether they're in shipping. Contrast that with if you back the clock up 10 years ago to 2015, 2016, that number was about 17 billion. So, you know, we've introduced a lot of new and highly technical and capable solutions, but really there's a human element in all of this that requires close attention. And this is where training compliance really comes to a head. And that's what really my focus is with Stay Cool Logistics and then also Cold Chain Navigator.

Bill White 12:40

Okay. Jim, uh, there's a lot to this. I've got a 10-page uh outline in front of me, and we don't have all that much time. We uh we want to make sure this podcast series continues along the cold chain uh outline, and there's so many permutations to all of this, ranging from data retention, it's minute things like time synchronization on the time stance of the uh data point captures and all. We have a lot to talk about in the future. I hope you'll be back with us.

SPEAKER_02 13:14

Yeah, absolutely. Just in closing, from my perspective, the freeze version, I think, you know, I first learned about this uh a while back, had the good fortune to talk into some of the technical folks at Testo, and it's gonna provide relief for unplanned or uncontrolled updates that clients really don't anticipate and and are unwanted. And the fact that the different versions of Severus One that are going to be out there are gonna be supported by Testo. It's really a critical aspect in balancing, planning, budgeting, and compliance.

Bill White 13:46

Okay, and uh Jim, uh, where can people get in touch with you if they want to further this discussion?

SPEAKER_02 13:53

Yeah, I'm present on on LinkedIn. If they look up my profile, they can send me a message through LinkedIn, be happy to converse with them initially, and then I can provide them some more direct contact information um at that time.

Bill White 14:07

Okay. And I think it's important that we say that you're not an employee of Testo. You are a an industry consultant, and you graciously uh agreed to help Testo educate the market, which is uh essentially what we want to do here.

SPEAKER_02 14:22

Yeah, that's absolutely correct. Yes.

Bill White 14:25

Thanks, Jim. We've been with Jim Bacon, the president and founder of Stake Cool Logistics Consulting. And Jim, a great resource with years of industry experience. Thank you very much again. And we're gonna be back with you uh sooner than later.

SPEAKER_02 14:41

Thanks so much, Bill. Appreciate it.

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