Mettler-Toledo International Inc. (MTD) Earnings Call Transcript & Summary

Welcome to Mettler-Toledo's Lab Webinar. My name is Renee Doran, and I'm a lab market specialist here at Mettler-Toledo. Get the most out of today's webinar. Don't worry if you miss anything, we will have it on demand on our website shortly after this live session. Participate in polls. We would love to hear your perspective and also there will be a survey at the end of the webinar. Utilize the chat function, enter your questions throughout the webinar. And if you're having technical issues, go ahead and reload your browser first to establish a new connection. We offer a broad range of solutions across our customers' value chain. This will help you to streamline your processes, enhance productivity, reach compliance with regulatory requirements and optimize costs and reduce waste. And now on to the webinar.

Hello, and welcome to our webinar about the management of weighing data in the lab. But before we start, let me ask your question. Did you ever write someone's telephone number down only to later find you had written it incorrectly. And what about when you were young, did you play the game of telephone where the first person whispered a message to the second and so on until you get to the last person to see how the message has been transformed into something completely different. Sometimes the final message could be hilarious. Might be funny in these children's game, but would you find that amusing if it were to happen at work, especially in a laboratory environment? Because in the laboratory, the exact same thing can happen to your weighing data. We're all human, and it's all too easy to make a mistake when copying down numbers, especially if you get distracted or if you feel under pressure. And just like the game of telephone, the more times we need to copy information, the more chances there are for mistakes to occur. So what can we do about this in the laboratory? Fortunately, there are various measures you can take to reduce the risk of data handling errors occurring. But let's first have a look at the bigger picture of data handling as well of the traditional way of managing weighing data. Nowadays, connectivity and information are everywhere and an immense amount of data are being generated and processed at a very fast pace. In laboratories, data are constantly being generated throughout each and every analysis. In fact, many quality control processes are based solely on such data. For example, determining the dose uniformity in the metered-dose inhaler involves weighing the inhaler after each discharge to calculate the dosage rate for each one of over 200 cycles. Metered-dose inhalers are used for treating asthma, chronic obstructive pulmonary disease and other lung conditions characterized by the restriction of airflow and shortening of breadth. Each metered-dose inhaler typically contains the therapeutical active ingredient dissolved or suspended in a propellant, which are all mixed with stabilizing excipients. Actuation of the inhaler discharges a measured amount of the drug in a fine spray, which is inhaled into the lungs. An inhaler may discharge up to several hundred metered-doses of one or more drugs. Each actuation of the device may contain from a few micrograms up to several milligrams of the active ingredients. The United States Pharmacopeia, for example, specified several tests to ensure the inhalers quality. These include requiring manufacturers to be sure the correct amount of active ingredients are administered and to clearly state the number of actuations per container on the product packaging. Each piece of data collected while counting the doses recorded the weight values in calculating the dosage quantity for over 200 cycles, therefore, becomes relevant to your entire organization. In order to make data really work for your business and make it a valuable asset, it is important and necessary to understand and the best practice procedures within your whole company. Involving your IT personnel so that they understand the possible strategic directions for topics such as data harmonization, metadata requirements and data architecture is a good starting point. These assets all come under the umbrella of data governance. On the graphics, you can see here, the elements shown in blue are related to data integrity, which we will come back to later in our webinar, and the green are three important data topics that are relevant to every laboratory. Firstly, data architecture management. This is the process of defining and maintaining specifications for how your company collects, handles, stores and uses data. Secondly, data security management is the planning, development and execution of security policies and procedures to provide proper authentication, authorization, access and auditing of data and information assets. And third, data operation management. This is the development, maintenance and support of structured data to maximize the value of data resources to your business. Having a bigger picture of your laboratory data referred to as data architecture is essential. This is independent of the nature of the data, which might be either poorly digital based from connected solutions or collected manually from offline devices. Within this bigger picture, it's important to define both classes of data, such as personal data, test result data, measurement data, et cetera, and the excess requirements, which also forms an integral part of data security management. Under data operation management, it's important to eliminate as far as possible any breaks or interruptions in the flow of data. Data breaks are situations such as manual prescription of values, manual data entries to a lab system or the attachment of a document that cannot be accessed electronically. Manual transcription of data from an unconnected device to a lab data system is not only error-prone, but also limits the quality and the quantity of the associated metadata. This is because the user typically has limited visibility of the metadata, for example, last routine test, internal balance status, software versions, et cetera. And because of the time it would take to record all such information. Historically, there was no other way to record weight results other than write it down by hand, usually, in some kind of laboratory lockbolt or, alternatively, to print results on a strip printer and stick it to a lab journal. During experiments, writing a rate result down was useful to the next step in the process. And keeping a record of all experiments, logbook provided scientists with evidence of both successful and unsuccessful experiments exactly. And it's the same principle in manufacturing of a product or a medicine. For example, a logbook would provide evidence of how much of each component was used in the formulation. This all sounds great, but studies have shown that errors occur in up to 5% of all manual data entries. And up to 95% of those errors are transcription errors. Interestingly, transcription is more accurate in the morning indicating that when we get tired or when the pressure to complete daily task increases, we are more likely to make mistakes. Additionally, the physical nodes or print outs may not be durable as it seems. Paper may be affected by humidity, sunlight or other factors, and its quality can deteriorate with time which may cause issues in reading or retrieving the information later. Furthermore, archiving handwritten journals and print outs over long periods of time may require significant amount of space dedicated for storage and retrieving data from such an archive can be challenging and time consuming. So what can we do to avoid transcription errors in a laboratory? Whether you are working in food development lab, creating new recipes or you're making a medicine, the weight data is absolutely critical. So firstly, let's look how some of the data is entered into the balance. For example, do you need to enter your ID to use the balance? If your details are saved under your own profile, the balance can correctly record who has carried out which task without the risk that the user ID has been entered incorrectly. To ensure sample IDs are recorded correctly, a barcode reader is the perfect solution. One of the simplest and easiest changes you can make to avoid arrows is to print out new weighing results. The print outs can be stuck into your logbook and the user ID can also be printed out with the weight results to provide records of who performed the way in task. However, you need to consider what we said before about the durability of paper in general as well as what data your balance is able to send to the printer. So check settings on your balance, where you should be able to configure your printouts. Take a look at this weighing results. It's at 0.426, but is that 0.426 milligram, grams or even kilograms? And even if I know the unit on its own, that doesn't tell me much. If I don't know what substance is, when it was weighed, who weighed it and is the weight within my process tolerances. So this is additional information that adds quality to your weight result and is referred to metadata. Metadata is data that provides information about some other piece of data. So to make it simple, it's data about data. There are many different types of metadata, like descriptive metadata, structural metadata, administrative metadata, reference metadata, statistic metadata and leading metadata. Metadata is normally used to summarize basic information about data that can make tracking and working with specific data easier. Some examples include the means of creation of data, the purpose of the data, time and date of creation, the creator or author of data, the location on a computer network where the data was created, standards used, data quality and the source of data. To give you a real-life example, a digital image may include metadata, such describe how large the picture is, the image resolution when the image was created, the shutter speed, et cetera. In the laboratory, the metadata may include the user ID, information about the instrument used for the measurement, substance expiry date, et cetera. All the metadata may be relevant for audit purpose or when trying to identify a source of error. Thanks for that. So we have managed to eliminate one source of error by printing our results. But what do we do if we want to investigate the results, analyze the data and look for trends. Traditionally, we would manually enter them into a computer. Unfortunately, manual data entry into computer is another way which transcription errors can easily occur. Entering data in this manner is also quite time-consuming and needs a lot of care. An alternative solution is to use special software that enables you to transfer the results electronically from your balance to the computer. Mettler-Toledo is EasyDirect software transfers weighing results in the required format to your PC, along with certain metadata. You can now save the results and analyze the data as you require. With our EasyDirect software, you can collect weighing data automatically. The amount of metadata that can be included depends on the connected balance. However, for example, the metadata might include the weight value with the unit, time and data, sample ID is entered into the balance, net cross tail weight and user name. The software makes analyzing weighing results very convenient as they can be reviewed from a computer screen and filter by date, instrument, user or sample. Results can even be visualized in charts, for example, to assess target and tolerance ranges. You can also create reports purely for documentation purposes. EasyDirect uses a professional SQL database to enable data to be stored verity of formats such as XML, CSD, XLS-PDF, which can then be imported to a PC or printed on a network printer. And by using this kind of software, you removed two key steps in your data handling process that are prone to significant errors. This is a good solution for many laboratories because not only does the number of errors go down, but also by removing these labor-intensive steps a significant amount of time is safe. However, a weak link in this method is that it's possible for the data to be altered without detection. This method is not sufficient for laboratories in highly regulated environments, which must be able to prove the integrity of their data as well as meet compliance requirements such as those of the FDA. Wait, data integrity? What does that actually mean? And how is it different to data management? Let me quickly explain data integrity to you. Do you remember the telephone game I mentioned at the beginning of the webinar? How the message is altered while being passed between multiple people and end up completely different from the original input? That is the principle of data integrity seeks to avoid. Data integrity is all about ensuring the accuracy, consistency and completeness of messages. This is the data in a regulated environment, such as the pharmaceutical industry, there is official guidance for data integrity that must be followed and is expected that organizations implement meaningful and effective strategy to manage their data integrity risks. The best way to achieve data integrity is to follow the ALCOA+ principles. ALCOA was actually developed to help laboratories, universities and companies achieve data integrity. Let's go through the points of the ALCOA acronyms, which states the data must be, first, Attributable. This means we need to record who performed certain actions and when. For example, Technician X performed basic weighing on March 17, 2021, at 9 a.m. Second, Lateral. Data must be readable throughout the entire life cycle of the record. Quite simple, bad handwriting is not permitted in this case. Third, Contemporaneous. This is documented at the actual time of the activity, not an hour later or the other day. Fourth, Original, meaning you need to be able to present our original record of the data for alternatively and certified copy. Accurate, data should not contain any errors for editing without documented amendments. It should be reliable. ALCOA+ principles were added to help those persons responsible for data integrity, including executives, administrators and lab technicians handle data more easily and meet the challenges related to electronic records. So what does the plus part of the ALCOA+ stands for? Well, in addition to ALCOA, data must be first, complete. All data, including any test, reputation or reanalysis perform must be complete. Consistent, all components of the analysis such as the sequence of events followed update and time stamp in the expected sequence, [ ensuring ] this means a sustainable record, systematically documented in a laboratory notebook or validated system. And fourth, available. You must be able to access the data for revenue, audit or inspections over the lifetime of the record. There are core principles for data integrity. Can be achieved through traditional manual transcription processes. This involves two people checking all data at every step. And if an error is found, any correction in the logbook must be signed and countersigned. Clearly, this takes a lot of time and effort and also necessary, not very productive and there is a high risk that data integrity may be compromised by a small error in the process. More importantly, many warning letters issued by regulatory bodies concerned this manual process and their recommendation is to digitalize it. So we have touched a little on data integrity as this is the important consideration in your data management strategy. However, what we have mentioned today is just the tip of the data integrity iceberg. And if you would like to quickly get your hands on more information, then do please visit our expertise library at www.mt.com/library. An efficient, reliable and ultimately cost-effective solution for data management and also data integrity is to use software such as Mettler-Toledo LabX. LabX is a PC-based software to which you can connect up to 60 Mettler-Toledo instruments via your internal company network. This network connected instruments, centrally controlled and managed via LabX, offers a range of benefits. With your balance or other instruments connected to LabX, you can start your weighing task with just one click on the balanced display. LabX software provides clear instructions on the display to guide you through each step of your SOP. Whilst achieving data integrity is never very simple, with LabX, weighing processes, including data handling, are greatly simplified for the operator. Therefore, less user training is required and all of the steps of the workflow are less error-prone. All critical activities such as calculations are performed automatically. LabX saves all data and metadata and a secure database, providing you with full digital automated documentation and fully supporting you with data integrity. Let's not forget LabX can integrate with any system that can handle CSV, XML or API web services. Even if you don't work in a regulated environment, LabX greatly simplifies data handling processes, saving time and eliminating transcription errors. Implementing LabX is a big step towards automation and digitalization in the lab, which will become essential in the latter of the future. When they think of automation, many people picture lab instruments working alone to make their measurements faster and less error-prone. But that can only be possible with sophisticated software such as LabX that can handle the process and data in the background. So let's summarize and look again at the three potential solutions for improving accuracy and ease of data transfer and management. This may be particularly interesting for labs that are still largely reliant on hand it results or which use manual processing, including keyboard entry at any stage of data notation, storage or analysis. Option one, simply add a printer. So one basic way to eliminate a certain amount of transcription error risk is to simply add print out capabilities to your balance, scale or other analytical instruments. This is a simple way to document and store original data. You can connect a printer to any Mettler-Toledo balance. Here, you can see how easy it is to connect printer to one of your standard level balance via the RS232 port. Option two, use EasyDirect balance software or EasyDirect moisture. To eliminate manual steps and related transcription errors, our advanced and standard level balances for halogen moisture analyzers, they can be connected to EasyDirect software installed on a PC. This enables weighing results to be collected, stored and processed electronically. Option three, integrate into a network. Instrument control software, such as Mettler-Toledo's LabX, offers more than just data capturing and data management. Users are fully guided through complete workflows according to individual SOPs, data, including metadata is stored centrally and all steps are fully tracked. And this way, the reliability of results is significantly improved and traceability is assured. Up to 60 instruments can be connected to LabX via internal network and all can be controlled and monitored. We have one central PC. If you have other instruments from Mettler-Toledo, such as thermal analysis systems or automated reactors, in situ analysis, we also have our IC and STARe software that can fully support you with data management and other departments with the need of your company. Just get in touch with us if you would like more information on these. While there is no right or wrong way to capture data, each of the solution mentioned offers a certain level of security, error mitigation and time savings not afforded by a primary handwritten paper-based system. Whether you choose to add a printer, connect to a PC or go for fully integration with the workflow and data management systems such as LabX, capturing data at the point of origin is the foundation of any effort to enhance data accuracy and integrity. Capture at this point without manual transcription helps eliminate errors using a high level of automation and data capturing, including the implementation of simplified self-documenting processes can further eliminate transcription errors and avoid unnecessary data retyping. It also can help to ensure metadata is captured in a structured way so that it has meaning for future analysis and audits. At Mettler-Toledo, we understand the different needs of our customers and believe in the values of the three levels we offer. We also support you with appropriate accessories such as barcode scanners and printers, and our balances have multiple connectivity options or interfaces. Our software options are also designed to meet different requirements, EasyDirect for simple data transfer and LabX for sophisticated data integrity and full digital and automated documentation. We've now come to the end of our webinar. We hope that we have helped improve the understanding of laboratory data management and its importance to your entire laboratory processes. We have presented a range of options that can help you improve your data management processes, no matter how simple or complex your requirements are. If you have any questions concerning the Mettler-Toledo solutions for laboratory data management, please contact your local solution expert. Thank you for watching.

I hope you enjoyed the webinar. Please scan the above code for more lab webinars, gain access to our wide knowledge base and tools by visiting mt.com There, you can access white papers, guides and user newsletters. And now on to questions.

Does anyone have any questions? I saw question in the chat asking if this video will be available later. The answer is yes. And I promise I can spell available. Is it [indiscernible]?

Yes, yes.

Yes, [indiscernible]. So the LabX software can integrate with the LabVantage software. It's a choice of whether you wanted to integrate that using the file-based approach with the CSV and XML files, as Stephan mentioned, or the direct integration approach using the API. We have many customers integrating LabX with LabVantage Hopefully, that answers that question. Let me know if there's something further. You can certainly feel free to go off mute and ask your questions as well if you didn't want to type into the chat. I thought is not still waiting to hear directly from a rep from Mettler.

Sorry about that. I have too many windows open on my computer. So we're still waiting to hear about getting the LabX software installed and integrated, but I'm working on the limbs side of the installation. So I'm just wondering if there's any materials that I can look at prior or to having it set up so that I can start building out our master data in terms of like our test methods and what creamer less would be required and...

Did you already purchase LabX?

Yes, we have, but we have all we haven't installed it. Everything is printed right now, we're just manually transcribed in terms of data acquisition and documentation.

Okay. All right. So you're having one of our software technical specialists come on site to assist with software implementation and validation getting everything set up.

Yes. I'm just -- we're still in the preliminary stages. And since my colleague is going on paternity leave next month, I'm probably -- I was just trying to get a jump on because we're a 2-person team.

A huge team. So are you using the file-based approach then? Are you using the API, do you know?

I think that we're going to be using the API.

Okay. So there is a system integration guide included with the LabX software. So if we receive that USB drive in the documentation folder, there is a system integration guide, which should give you everything you need to know. If you are having trouble locating that, I can certainly send over a copy to you as well.

That would be great. I would really appreciate it. I may have it already, but I know that I know that something was because we had a demo done recently, but I don't know if I ever received the integration. So I don't think I got that guide. Yes, I would appreciate it.

We can certainly send that over, certainly.

All right. Great I think that's all my questions. I just wanted to double check because the person that was giving the demo gives a little bit of a big answer to us.

Is that me?

I don't think so, maybe. It may have been.

The name of the company, I'm sorry.

SCA Pharma. Was it you?

Yes. It was me actually. Yes.

Sorry. There were a lot of people on the call at that time and trying to...

So really when using the API comes down to what information you're trying to transfer back and forth, are you importing and exporting or just exporting?

Importing. So ideally, importing and exporting just to give you -- I don't know how many people are still on the call, but just to give you some background, like I was a chemist and very familiar with using all the instrumentation that's in the lab from Mettler and I use in multiple other companies. And then I've recently switched over. So I'm trying to help set this up and design it so that it's like user-friendly for the kindness because a lot of them are not most technically savvy... Multiple e-mails like, "I can't get on." I'm just, "Are you using your password?"