May 14, 2021

Reuel Sample: Thank you for joining us on the KENX podcast. I am your host Reuel Sample. Joining us today is Joscelyn Bowersock. Jocelyn, how are you today?

Joscelyn Bowersock: I am great. Thank you so much for having me.

Reuel Sample: Jocelyn is a customer success manager with L7 Informatics. She is an experienced quality regulatory manager with a demonstrated history of working in the medical practice industry. She is skilled in good laboratory practice and good manufacturing practice, quality management, molecular biology, cell culture, and US Food and Drug Administration. She has a strong legal profession with a master of science focused in regulatory affairs, compliance from Northeastern University. Jocelyn is also going to be presenting at Cleaning University just next week. Let’s start off Jocelyn by asking you to give us a brief synopsis of what you’ll be presenting at Cleaning University.

Joscelyn BowersockJoscelyn Bowersock: I’m actually going to be giving two different presentations. The first one’s going to be going over the best documentation practices for critical information. In this one, we’re going to be focusing on not whether paper or electronic is better or worse than the other, but really how to make sure that the documentation practices that you have and that you are implementing currently, are going to be able to last you and meet regulatory requirements as time passes, making sure that all of those pieces and parts are saved correctly, are visible to the correct people, really making sure that you can get the most out of the data that you’re collecting, because just collecting numbers is one thing, but actually being able to do something with those numbers is really the point of data collections.

The second presentation is establishing a sample sites and doing a risk-based sampling plan. So often we fall back on our qualification protocol and say, “Oh, well, we sampled all of these sites. So we got to keep sampling all of these sites.” It doesn’t necessarily have to be that way. We really need to look at, does our sampling plan allow us to work effectively, but does it also capture all of the information that might be relevant in a manufacturing process? We’re going to spend some time going through how best to go through that process and choose which areas might be the highest risk and the lowest risk, and develop a comprehensive sampling plan to move forward. So-

Reuel Sample: It’s interesting on your first presentation, you talk about focusing on how your document system will last. Have you run into situations where a company will put into effect a documentation system and it doesn’t withstand the test of time?

Joscelyn Bowersock: Absolutely. Everybody falls back on paper because you know, paper has been around for thousands of years. I can tell you more often than not, I’ve gone back to older documents. You know, many of these documents, they say you have to keep them for six, 10, 20 years, depending on the type of product that’s being developed, and I’ll pull out pages and they will be completely blank because of the type of ink that was used, because of the type of paper that was used. And so you look at it and go, well, it’s great that I have this piece of paper, but I’m not getting anything out of it because it’s blank. Is what I’m using actually going to last that entire time?

And the same goes with computer systems. I’m sure that 20 years ago I was not using Windows, whatever version we’re on. We were barely hitting up Windows ME 20 years ago. Now, if you look at somebody and say, I’m using Windows ME, they’re going to look at you like you’re insane. Software develops and is in a constant state of flux and transition. So is what you have currently going to be able to be moved forward. It’s not going to be a static aesthetic point. And so if I download or if I update the newest, latest, and greatest, are they going to be compatible as we go through. If all of my people decide to quit tomorrow, how easy is it going to be for me to spin up a whole new manufacturing plant, train all these new people on the system that I’m currently using, because it’s not just will the data still be there, but will the people that are filling out this information be able to use it? And is it going to prevent me from moving forward?

Reuel Sample: What you’re talking about, ink being erased over the years or the computer systems going out of date, that’s not in the realm of fantasy. That’s actually happening in the industry where companies cannot provide documentation from years ago because the data is just not available.

Joscelyn Bowersock: How many times do any of us want to get online and see maybe a document from 20, 30, 50 years ago, and it’s scratchy and the quality of the scanning isn’t up to par. So you sit staring at the page going. I’m not sure what that says. It’s not just our industry, but all the industries trying to make sure that data from historical perspectives are still being captured and are still relevant.

Reuel Sample: What will be some of the biggest takeaways that our attendees, at Cleaning U can expect at the end of the presentations?

Joscelyn Bowersock: The biggest takeaways are going to be risk analysis tools. How can I manage the risk, whether it be a documentation risk, whether it be my sampling plan risk, how can I, how can I manage those and maintain my compliance going forward? So what kind of tools do I need? And I will give you all of the tools at my disposal and also working for an informatics company, I’ll give ideas on how best to develop processes and plans going forward. So if you are in a paper-based system and you’re looking to move to electronic, I’m going to help and give you the best tools on how best to move from that paper to the electronic system, and then how to maintain your electronic systems going forward. And to capture both your documentation risk, but also your sampling plan. That can be electronic as well. Maintaining your schedules. I’m sure we all use some sort of Outlook or Gmail Calendar. You know, how do we make sure that the visibility for everything is moving forward? So I’m here to help maintain compliance and risk.

Reuel Sample: We’re talking with Joscelyn Bowersock here on the KENX Podcast, Joscelyn is with L7 Informatics and talking at Cleaning University here next week. You just talked about risk. What is acceptable risk?

Joscelyn Bowersock: What are you willing to accept? What is acceptable risk for me may not be the same acceptable risk for you. As we’re going forward. We’ll think of, because this is Cleaning University, we’ll think about cleaning. Is the cleaning that I perform on my floor any more or less important than the cleaning that I’m performing on my table or on my lab bench or in my biosafety cabinet? The acceptable level of risk is based solely on what is your acceptable level of activity in that area? I don’t have to lick the floor. I don’t have to use my chair as my lab bench or use my hands as an incubator. But it’s the idea of, is there a risk that I am posing on my product because of where it is? So my level of risk for my floor is going to be maybe a little bit less than it’s going to be for my biosafety cabinet or for my isolator or my bio reactor. It’s an inherent risk based on what it is that you’re doing. An acceptable level of risk is totally dependent on what you decide is your level of risk for that area.

Reuel Sample: But it has to be a decision. It has to be a decision. It has to be something that the company thinks about beforehand. Before doing a risk analysis, you have to understand what is an acceptable level of risk.

Joscelyn Bowersock: Absolutely. So one of the first things in establishing your levels of risk is establishing a business process and you wouldn’t believe how many people, and me included, sat there going, you can’t do a business process on a lab process. It’s just… It is what it is. You go, and you do this. But really by breaking down the process into stages, or even doing a spaghetti diagram in your lab saying, “Okay, well, this part of the process has done here. And this has done over here, and this is done over here.” Maybe you’re making your stock reagents in one place, but you’re processing the product in another. You need to look and see where those critical process activities are, where those are taking place. You have to identify what your critical process activity is, and then you need to decide, okay, well, if my critical process activity is making my stock, and because it’s going to go straight from this area to my isolator, I know my isolated is going to be cleaned. So I have a lower level of risk here as I would out in the open, when I’m making it. Then your increased risk will be where you’re making it rather than where you’re using it, you’re using, it would be the risk of the actual procedure itself. There are… You have to understand your business model before you can really even understand the risks associated with your business model.

Reuel Sample: Now here’s the great controversy question of our podcast. Have we become too risk averse? We have to, in the life science industries, we have to understand that our end user is the patient and we want to be very careful, but have we become too risk averse? And is that stifling growth and innovation?

Joscelyn Bowersock: You know, part of me wants to say, yes, we have. Which as a quality person, you never want to hear your quality person say, “Oh my gosh, so you can’t be too risk averse.” I do believe that in some places we are too risk averse. So we are almost painting ourselves into corners. I’ve worked with a lot of companies where they would rather follow the higher, more stringent level of requirements, even though they don’t actually apply to the process that they’re doing. They want to go ahead and follow those because then they know that they’re already inspect for what they’re doing. I look at them and I ask, I was like, “So this isn’t, this isn’t applicable to your process. Why are you doing it? Why are you creating a stop gate for yourself? Why are you adding.” And it actually happened to be cleaning.

“Why are you adding this financial burden to yourself?” So we’re talking personnel to clean the facility. Then you also have cleaning agents. And then you have the time out to be able to clean the facility itself. And I said, “Why are you taking on all of these risks? Because every time you walk in there, you are introducing more contaminants, whether or not you’re cleaning. So you’re going to clean when you don’t need to clean. And you’re going to add more people to a system that was stable. Why are you doing this over and over?” And they said, “Well, that’s because that’s how we qualified it. That’s the highest level of regulation. And we know that we know that we’re going to be good if this is how we’re running.” And I said, “But you didn’t validate to be able to, you know, run at any other level. So did you really do a proper process analysis? Did you really do a proper qualification of your room and validation of your process?” And they couldn’t answer the question. They were so worried about doing it to uber right way that they weren’t thinking of. Could there be a better way? I think in life, we always want to do it the absolute right way when another way could actually be much more beneficial to our processes, to our businesses, as we move forward.

Reuel Sample: As you’re saying, is that trying to always put that check in the box or even create a box to check is oftentimes not cost efficient, slows down, slows down and results and is not needed.

Joscelyn Bowersock: Exactly. I used to work in a clean room that was extremely tiny. It was probably 40 feet by 40 feet. So it was very small for the amount of equipment that we had in it. But we ran that HVAC system so hard it sounded like in an airplane overhead, but my ISO-6 cleanroom was running at particle values that were hitting up ISO-5 and ISO-4 because of the way that it was running. And there were like, “Well, that way we don’t have to worry about it.” I was like, “But we’re spending so much time and so much effort to keep the room at a level of cleanliness that we don’t need to achieve.” It actually ended up, we had to take the room down multiple times because we were pulling the paint off the walls because we were cleaning it so much because we’re using a paint that was designed for an ISO-7, ISO-6 room. And we were using cleaners for an ISO-5 ISO-4 room. So-

Joscelyn Bowersock: You do have to be cognizant of the stuff that we put into the space. Does it meet our requirements? And are we going to prevent ourselves from working because we’re working outside of the spec that we built it to be.

Reuel Sample: That doesn’t mean that you should not be up to spec, but going over and above spec has its own costs and its own problems.

Joscelyn Bowersock: Yes. Doing extra work, doesn’t always mean extra credit.

Reuel Sample: Final question for you for today is that we have been hearing the term digitalization. Whether it is with document management or other areas, what does digitalization mean to you?

Joscelyn Bowersock: Digitalization, I guess in the dictionary sense of the term is converting your paper to electronic. So it’s converting your manual processes to a digital process. In the most basic form of the term it’s, if I would write it on a piece of paper, I’m going to write it in a word document, I’m going to put it into an Excel file. I’m going to put it onto something electronic so I don’t have to keep track of this piece of paper anymore. That is the most basic sense of digitalization.

If we were to take that a step further and say, “Okay, well, I actually want to digitize something. So digitization. We’re thinking about not just the input of these are all the values that I would already have, so this is what I’m going to use. It’s the actual conversion of your process to an electronic format.” So things that I would normally have not even thought of like, “Oh, well, I can actually transfer this piece of information over here and I can have it auto-fill this piece and I can move information around and I can see different things.” That would be the truest sense of a digital process. We’ve all traveled. Or we all used to travel.

How long ago was it that we would actually have to go to the ticket counter, and we’d have to purchase our ticket and it would have our name on it and you know, the whole nine yards. And we’d do that long before our flight ever happened, because we’d have to actually go physically see somebody in person. But now if you say, “Oh yeah, I bought my ticket at the ticket counter.” People, probably aren’t going to know what you’re doing because you can go on your app, you can do it there, you can go on the website. You don’t have to talk to a person because it’s all digital. All of the transaction happens on a computer, on an electronic system. And so if you think about it in terms like that, not just, “Oh, well, I’m moving a piece of paper to an electronic format.” It’s the actual full process of I’m taking this sample, which is in my hand, but I’m going to convert all of its associated data, all of its results, all of its law information. I’m going to convert all of that information to a digital format. So that way I can see and parse and manipulate all this data. So I can see exactly what it is that this sample is. That is digitalization. That is becoming a truly digital system and process.

Reuel Sample: Will it be achieved?

Joscelyn Bowersock: Probably sooner rather than later, right now we have so many siloed processes, so many siloed software programs. It’s, you have this software program that does this and you have this one that does that. So just like we have Word that it does really great. If you want to type words, we have Excel, which is a great data ingesting tool. We have PowerPoint if we want to get into more, more graphical design, but we can’t merge them all together. And so I think that’s where we’re sitting at right now, is you buy one to take care of your inventory, buy one to take care of your finances. You take another to handle your scheduling. You take another to be able to manage your samples and to manage your production processes. And you have all these different pieces that don’t really talk well with each other.

So you have to buy another third piece to input different pieces of information that you might be able to see, and it might be able to do something with. So, we we’re slowly getting there. I feel that we will probably see it in our lifetime. I know L7’s working very hard to de-silo the whole data stream, but I do think it is possible out there. People just need to be a little bit more gung ho on pushing forward with their needs for an electronic system.

So many people don’t want to move to electronic because of FDA regulations because of EU regulations or even because of business processes. It costs a lot of money to move from paper to electronic. But if your data is lost, there’s usually a few backups in electronic. There’s usually not a whole lot of backups in paper. And people are seeing that. If we can get to more secure ways of handling that data management, I think we’ll see a true digitalization probably in the next 10 years or so.

Reuel Sample: Joscelyn Bowersock from L7 Informatics, who’s speaking at Cleaning University. How can they get in touch with you?

Joscelyn Bowersock: So you can get in touch with me. I am on LinkedIn. We’ll happily reach out to anybody, look up L7 Informatics. You can reach me there as well. So first name, last name at L7informatics.com.

Reuel Sample: That’s the website is L7informatics.com. Joscelyn, thank you so very much for being here and we’re looking forward to your presentation at Cleaning University.

Joscelyn Bowersock: Awesome. Thank you so much for having me. It was, it was an absolute joy.

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