The 5 Most Common 21 CFR Non-Compliances And How To Avoid Them

Transcript

Hello, everyone, and welcome to today's MDDI webinar.

The five top twenty one CFR noncompliance violations and how to avoid them. Sponsored by Limble and broadcast by Informa.

My name is Mary Nelson, and I'll be moderating today's session. We have just a few housekeeping items before we begin.

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To help introduce our webinar today, we have the top five twenty one CFR noncompliance violations and how to avoid them. Discussing today's topic, we have Chad Shermer, a customer success manager and CMMS, guru at Limble. A little bit about Chad is that he has a keen focus on twenty one CFR compliance and nearly a decade worth of experience.

Chad works closely with clients to educate and empower them in their critical roles, ensuring smooth operation and regulatory adherence.

This dedication helps teams maintain product quality and meet regulatory standards effectively.

To learn more about Chad, please visit our speaker widget. But, Chad, we're really excited to have you today.

Yeah. Very, very excited to be here, and thanks everyone for joining in.

Customer success over here at Limble, and I do I work with a large portion of our twenty one CFR customers, and they're some of my favorite customers often working in, you know, complex, cutting edge industries doing cool things. So I'm excited to talk a little bit today a little bit more about twenty one CFR and some of the noncompliance issues some customers can run into.

Perfect. Chad, just to kind of toss things up or kick us off, can you explain a little bit more about what twenty one CFR is and what happens during an audit?

Yeah. Definitely. So twenty one CFR.

So in the the most broadest kinda general definition, twenty one CFR is a set of FDA regulations, important regulations.

You know, why are they there? They're they're there to aim, to ensure the safety and effect, efficacy of certain products and industries. So important regulations covering a wide variety of in of industries.

And, as part of that twenty one CFR procedure, there's, often an audit. And what happens during that audit, auditors will come and perform a thorough review of your company records. They'll be looking for, you know, anything required by that policy practice or maintenance tasks. Those have been performed, documented, recorded correctly, and they will be looking for, a lack of documentation. And So, very, very important, and it's a key reason why a good CMMS is very important. So that these a centralized place for these records, for the documentation, so all of that can be found, located, reviewed, and available when these audits do come up.

Perfect. What are some of the industries that you see twenty one CFR, popping up with most often, or where is it most common to find find twenty one CFR affecting, maintenance teams?

Yeah. That's a great question. So a lot of the customers that I work with are in medical, be that medical devices, medical equipment, medical instrumentation, as well as pharmaceuticals or, you know, parts of that pharmaceutical process, be that add add ins or mixtures or different chemicals or containers, things like that. So a lot, a lot of my customers do work in that medical, pharmaceutical, consumable, supplemental, industries.

Very nice. And if anyone's joining today that wasn't mentioned, feel free to shout out your industry or, raise your hand. We love kind of making sure everyone feels included in that.

But, Chad, kind of going to our next point, how does twenty one CFR impact the maintenance teams that you are working with?

Yeah. So so very importantly, there are two primary parts I wanna talk through here, and that's part eleven and then part eight two zero. So part eleven, refers back to electronic records, electronic signatures, and both the scope and application of electronic signatures throughout the maintenance process. And then part eight two zero is the quality system regulation, the QSR, for medical devices.

So part eleven, electronic records, and that includes, closed system controls and also maintenance record retention, audit trails, access controls, and system validation. So we see all those records that are stored, detailing maintenance procedures, maintenance tasks, planned maintenance, all of that, as well as the electronic signature piece. You know, are we properly capturing, and verifying who's doing the work, when it's being done, and do we have that all stored, and we're able to refer back to that. And then part a two zero, the QSR for medical devices, mandates along the lines of performance for routine and scheduled equipment calibration, inspection, and maintenance.

So preventative maintenance, routine annual calibrations, inspections, things like that for these important pieces of equipment.

Perfect. Thanks for kinda covering that. I know for some of you joining today, it might seem like a review, but we know that any audit for your teams can be a big one. We wanna make sure that you are prepared, know what to expect, before we jump into the non compliances. So that way, it makes a little bit more sense as far as how these issues are impacting maintenance teams. So Chad, let's go ahead and dive in.

To get started, we have our first noncompliance, which is inadequate documentation.

So I have an example here up on the screen, which occurred back in August of twenty twenty three with Lex Inc. And in an essence, Lex Inc didn't properly record the times when they didn't follow their standard procedures.

This includes not documenting reasons for changes, how those changes impacted product quality, or what actions were taken to address those changes in product quality. So I'd love to get your thoughts on this situation, not only just the noncompliance, but also this example with Lex Inc, because I think there are some teams that are familiar with this.

Yeah. Definitely. So we're gonna cover these five use cases. And there there there will be some general themes that we'll see with almost every use case.

And one of those will be documentation. You know, are we properly documenting all these different tasks that we're doing? And since I work with a lot of our twenty one CFR customers, I know that sometimes these processes in the, you know, the volume of tasks, it's a lot. These are they're complicated processes. They're complex tasks. We have important, instrumentation and equipment that has some strict requirements.

And so it's not easy to properly document and maintain all of these records. And this use case was a good example of where that was not happening. And it can be difficult depending on, you know, if we're storing them in different locations and file systems, maybe some on paper or in different Excel, you know, sheets or databases and things like that. So a primary way of verifying that we are documenting what we need to be documenting and we can refer back to it as necessary is to implement a good CMS, a good modern CMMS.

It becomes indispensable. It provides an organized method for simple documentation of all these tasks, these complex tasks and routine tasks I'm mentioning, and also documenting not just that they were done, but what was done, checklists, procedures, you know, the different kind of, instructional trees that we might have to do or complete for these checklists, for these maintenance tasks, and also that we're capturing the electronic signatures for these various tasks. So that's really how a good CMMS can step in is that you do have this centralized stored location. Your maintenance tasks are laid out. You know who did them, when they were done, any sort of additional comments and things are stored on that, and they can be referred back to, you know, just whenever you need just by logging in and finding the appropriate task or piece of equipment.

Yeah. Thanks for going over this. I know we had someone ask what is a CMMS. So I'd love you love for you to kinda go over what that is, for the audience.

Yeah. Yeah. Great question. So when I refer back to a CMMS, I'm referring back to a computerized maintenance management software, which is a piece of software and application that can help track these core maintenance activities that you need to complete. So a good CMMS should have the ability to, manage your assets or equipment where you can build out a detailed list of all the pieces of equipment and instrumentation that you are managing as well as then on top of that, list the routine maintenance that needs to be done, maybe monthly, quarterly, annual services, inspections, calibrations, build out all of that on top, and then track any additional tasks and work that are that are being done, be it a work order, and other forms of work that need to be done. So at the end of the day, you have this centralized storage of your equipment.

You have a a detailed schedule of what needs to be done, who is going to do it, and what are the the instructions or checklists or procedures that fall under that task.

And then you a good CMMS should also have other pieces of of helpful tooling as well to track spare parts, to look at your data, to build a dashboard, to track your users and and their permissions and things and make sure that your maintenance activities are running smoothly, and that everybody knows, you know, what needs to be done, when it should be done, and the detailed record and logs of all of that over, you know, quarters and years is stored, and accessible for you and your teams.

Perfect. Thanks, Chad, for covering that. I know sometimes it's easy to go into abbreviations, for those of us that work with maintenance teams. So thank you so much for shouting that out and asking that question.

So that way, we can make sure that this presentation as as helpful love So again, there is an example of this. I'm someone that loves to see examples. So that way, it just kinda clicks a little bit better and makes it a little bit more applicable to your teams and your jobs. So this occurred in March of twenty nineteen when the FDA cited a lack of effective quality control systems with KingBio Inc.

One of the systems high or one of the issues highlighted was, just the lack of effective quality control systems leading to deficiencies can tie into twenty one CFR and how those issues can be avoided.

Yeah. Definitely. So I think one of the key phrases here from this one is the inadequate procedures for cleaning and maintenance of equipment.

Now and that that makes sense because we we have, you know, often hundreds, maybe even thousands pieces of pieces of equipment, thousands of pieces of equipment that need to be cleaned, that need to be maintained. And, the procedures for cleaning and maintaining those, it can be difficult, especially depending on how we are storing those procedures or what we're referring back to. So what's nice about a a a modern CMMS, is that we build out these maintenance activities, but they're customizable, they're flexible, and we can continue to iterate and refer back to them and keep them up to date with any changes we have to our production workflows or our equipment list and and things like that.

You can imagine that with a static list but an ever changing, you know, kind of manufacturing facility, we might eventually see miss, misalignment there and be, have important parts of our maintenance activities be forgotten or not recorded properly and then not done in the future. So a modern CMMS will give you the ability to always refer back, to iterate, and customize, and make sure that those procedures and all our maintenance activities properly align with SOPs, you know, manufacturer requirements and that we can keep that up to date and standard.

So this also mentions here this slide that they could also schedule and track equipment maintenance tasks, ensuring that they are performed regularly and according to established procedures. And that's one of the core functionalities, as I mentioned, of a modern CMMS is that ability to track that equipment maintenance, build it out, and have the tool assist you in verifying that those tasks are being generated, they're being done. And then if something is missed, you know, make sure the appropriate people are being notified and that teams can, you know, catch up and do any work that, you know, know, might not have happened when it was supposed to happen. So, additionally, the system could facilitate the documentation of maintenance activities, including records of equipment cleaning and calibration. And that's definitely a very core functionality and a and a and a necessity, in a modern CMMS or or managing our systems is to make sure that we have that proper documentation.

All that records be it as, you know, a simple cleaning or an in-depth calibration or a, you know, a large five year inspection service from the small tasks that are done, you know, weekly or monthly to those large tasks, making sure we have that properly documented so we can refer back to the full complete history of what has been done, for our important pieces of, equipment and instrumentation.

Perfect. And then also, as you were talking, one thing that I was thinking of is there's a lot of teams that need to pull that data as well. Right? So that when an audit does come, they can verify that those tasks were were done.

So thank you again for kind of walking us through that, how a system having a system in place can help teams kind of avoid these issues.

I'll go ahead and move on to our third noncompliance, and that is noncompliance with good manufacturing practices or GMPs.

So in this circumstance or in this example that we have cited cited, the FDA issued a letter to Friendda Corporation in February of twenty twenty three, so just earlier of last year, citing this noncompliance, for finished pharmaceuticals. And the FDA found issues with not testing their products, thoroughly, not having clear instructions for cleaning and maintenance, and not having adequate controls to make sure their products are safe and and of high quality.

So, Chad, again, with your clients that you work with and, your experience with twenty one CFR, how could this situation be avoided, and and what are your thoughts on this noncompliance in general?

Yeah. Definitely. Definitely. So GMPs, this is another great example. And I like this phrase here about not having clear instructions for cleaning and maintenance.

Because I often do see, you know, customers start out with instructions that may be a little general or vague, you know, replace this or clean this or check this. And that might work for some folk on the maintenance team who have been around, and they understand some of the intricacies there. But imagine a new a new team member, someone coming online or joining that team.

Having clear instructions is is incredibly valuable as teams grow and scale and manufacturing processes get more complicated or or, you know, scale up as well. So what's nice about Limble or other modern CMMSs is we can build out those instructions, and we can make them as clear as possible. We can also do things like attach instructional images or an instructional document to a single piece of instruction to help clarify, you know, where exactly, this needs to occur. Pictures, schematics, additional checklists, all of this sort of helpful, important knowledge and documentation can be uploaded into a modern CMMS and then is there on the go as a maintenance professional or a maintenance technician is out completing their work, pull it up on on their mobile device, on a tablet or their phone, access those pictures, and all of our equipment.

Regular maintenance, including cleaning and inspection of equipment, helps prevent contamination, removing debris, residue, contaminants that can compromise product quality and safety.

One nice thing about a modern CMMS as well is that, let's say there is contamination, you know, debris or residue, you know, maintenance, tech is going through and and performing maybe a a monthly inspection, and they do find something has built up or there's something out of the ordinary, a modern CMS solution will allow them to report that, maybe make a, a comment and loop in someone else to let them know what what has been found or even kick off a subsequent work order from my right there within with just a couple of clicks to record that finding and make sure it's recorded in such a way where it can be addressed later.

I know there's a lot of findings that occur as teams go about their day to day and having a a centralized place to store that is incredibly valuable.

It's also mentioning it just mentions adhering to maintenance schedules. Companies can minimize the risk of cross contamination. So, yeah, once again, back to those maintenance schedules that, which a modern CMS doesn't like, Limble does a great job at handling for you so that a lot of your additional mental energy and everything and and time can go towards some of these subsequent tasks. You know, letting the system handle those schedules, creating them, assigning them, and then sending those alerts and things if something does become late or overdue, can free up a lot of your space and make sure that teams stay on top of the most important tasks.

Perfect.

I know, just from my experience working with maintenance teams and and talking with them, I know a lot of the issues comes with just following the instructions that are laid out. And sometimes that's hard if it's this paper sheet that's kind of taped up and teams are expected to follow through with it. And sometimes those tasks, like you said, can be very general, when there's something very specific that needs to be done, that this newer generation of workers may not know, as we're seeing kind of a turnover in in generational worker workers. So definitely having something, like you said, in place can help avoid a lot of the issues that we've seen with twenty one non compliant twenty one CFR noncompliance.

I wanna go ahead and get us over to do do you have any other comments with that, Chad?

Yeah. I was just gonna say I I I work with a lot of customers who do have, they have new people coming on board, and and they really want these new maintenance managers and supervisors and and maintenance techs to, have the information they need to get up to speed and to understand the equipment. And sometimes that that that information, if they're they haven't been in the CMMS long or they're still onboarding, sometimes that information is spread all over the place, and it can be difficult for, you know, a new maintenance tech to to find that that information they need and really hit the ground running, with working on this important equipment.

So a modern you know, having a CMMS in place, having all of that stored, including, you know, findings from recent tasks or previous tasks, having all that available for new teams as we we do see shifts in teams and new people coming and people leaving, that it can can really help maintain just the the the the fluidity and, everything of a maintenance team.

Yeah. And just creating a general overall great experience, great culture for your teams, and setting them up for success.

I'll go ahead and jump into our fourth noncompliance that we have here, which is lack of proper equipment validation. So we, again, have an example. Each of these noncompliance which case, the FDA issued a letter to OFNU systems in February of twenty seventeen.

The FDA identified deficiencies in the company's validation processes, including inadequate process validation for manufacturing of drug products.

The warning letter and first emphasized this, proper validation procedures to ensure the quality and safety of pharmaceutical products.

So, Chad, let's kind of dive into this. What are your thoughts on validation process and how it can possibly be avoided with setting up a modern system?

Definitely. The, of course, the the quality and safety of pharmaceuticals and other products in industries and similar industries and adjacent industries is so important. And the overall kind of maintenance rhythm and the maintenance flow and how we manage our equipment, our calibrations, and everything play a massive part in the quality, of the products that we're creating.

So this is where I see a lot of customers, you know, really, buckled down and and and put in a lot of time and effort into managing and building and creating these processes, these workflows. So we have we have our standard processes and workflows, and a modern CMS solution will will be able to handle, of course, you know, building out PMs, routine PMs, inspections, calibrations, things like that. But we also a lot of my customers do have individual and and different work flows as well that they want to build out in Limble or in a CMMS. They have specific workflows or procedures for their specific equipment or their specific production facility and production lines.

And so that's really nice where if you do have a modern CMS solution, an adequate solution, that has flexible capabilities, you can build out all those additional workflows on top of the core workflows that you have in place, making sure that you've accounted for all the different processes, all the different validative procedures and, you know, inspection procedures, making sure it's all included in your CMMS, so that nothing's missing.

And all that, of course, rolls up into ensuring the quality and safety of these products, which is so important. So having a proper system in place could help this by help avoid this by facilitating equipment maintenance, proper documentation management, tasks, training management, data integrity, and compliance monitoring. So I wanna talk about those last couple of things real quick. Training management, as I mentioned, making sure new team members are up to speed.

They've been appropriately trained, on the different equipment and the maintenance, tasks that are done routinely. As I mentioned within Limble and other, and a modern CMMS solution, you can build robust, clear, concise instructions. You can include, you know, images and things to really help make sure, verify the integrity of these procedures that are being done. Data integrity, within Limble, your data is very available.

You can routinely check on your data, build dashboards, reports, look at your data, verify your data. So that's open and available to you, which I know is so important, especially now in twenty twenty four. Folk want access to their data. They wanna be able to look at it, review it, chart it, graph it, and everything like that, which is available in Limble and modern CMO solutions, and then compliance monitoring, monitoring the outputs, monitoring the, completion of tasks, monitor monitoring things like on time percentages for especially critical PM tasks and things.

I have a lot of customers that in the twenty one CFR space, of course, who are very, invested in their compliance.

And so we, together, we often build out certain reports, compliant reports, compliance, dashboards to make sure they can properly monitor the coming and and going of these tasks, and make sure that they're meeting their own compliance KPIs, for the organization. So this last paragraph, by implementing a robust c m a robust CMMS system, companies can streamline validation processes, maintain compliance with regulatory requirements, and ensure the quality and safety of their products.

Perfect.

One thing that is kinda interesting as you were talking about compliance monitoring, building dashboards, I think a lot of it goes back to being able to access and pull that data very easily. So that way, if you were to be audited or, I know we also have people that work in areas where OSHA audits are also, a big concern as well. Just having one system that you can pull that data from sounds like it's just so helpful for companies.

I know I'm someone that loves to look at data. And so I think having something that just takes that work away from you and saves you time is so helpful, especially for teams that have fires popping up day to day.

So before we yeah. What was that?

Oh, just one other thing. So within compliance monitoring, the customers that I work with, they often have compliance KPIs that are very, very important in terms of, a very common KPIs I see from a lot of my twenty one CFR customers is, you know, critical PM completed on time is a hundred percent. They want to see all their critical compliance based PMs completed before the due date, and there's not much wiggle room for that. They that's a very hard and important KPI that the entire organization is focused on. So within Limble, we can build out that KPI, you know, what percentage of our critical PMs are being completed on time. And these teams are often shooting for that hundred percent because they these compliance, monitoring their compliance KPIs and staying in compliance is so important to these organizations.

Yeah. Especially those industries that you mentioned.

We'll go ahead and move to our fifth and final noncompliance, which is inadequate complaint handling and adverse event reporting.

This situation is a little bit interesting. That's listed. It occurred in November of twenty twenty three.

With Cipla limited because the facility failed to properly follow-up on thousands of customer complaints, involving an inhaler.

So they received about three thousand complaints regarding this inhaler, mainly cater mainly these complaints were coming in as having no spray or empty or less weight. The company's investigation was found inadequate due to a lack of timely corrective actions and failure failure to extend investigations to other potential batches.

So, Chad, I know the situation is a little bit unique where it's more focused on complaints and complaint handling, but I think there are steps that need to be taken before you get to that situation where there's complaint handling. Obviously, there's an issue with the product that happens before the complaints come in. So I'd love your thoughts on this and and how it can be avoided.

Yeah. Definitely. Definitely. And also, you know, there is this phrase at the end of timely corrective actions, and that's something I wanna focus a little bit on because, you know, once these complaints are coming in and being handled or findings are being found, however that might be, whether it is coming from an outside customer, whether they're being found by our own internal teams or just investigations into our own processes.

At some point, there is gonna be the requirement that we are completing timely corrective actions. And some of those actions might be maintenance type actions or things that we will track in limbo.

Maybe change outs, replacements of certain, parts of tools and equipment, cleanings, or maybe even, you know you know, complete, installation of new equipment or new assets into our manufacturing process.

So once we have these findings and we start taking actions, the recording of those actions to refer back to for, in case we ever need to in the future or for audit reasons is very important important, not just documenting, the investigation and the findings, but also all actions taken and the resolution outcomes. And so a modern CMS can play an important role in this general process, especially in the documenting of any future corrective actions, any resolutions, and anything we might do from a maintenance perspective within our production processes.

So implement a system that can help to document all findings and actions taken and then and and actions taken in response to each complaint. And a flexible modern CMMS solution will allow you to create, subsequent work, and and tack onto it all the different pieces, all the different actions that might be taken in response to a complaint or a or a finding, have multiple people interacting, with that corrective action, properly, recording notes, you know, completion notes or just notes step by step as folk work towards riding the ship or or pulling things back to where we're meeting our SOPs in our in our manufacturing requirements there. So a lot of this one is unique and that it is kind of a a process from start to finish, but I think a modern CMMS can play an important role in in many of the important steps of that process.

Yeah. Definitely. Just getting those processes in place before the complaints come in. Right? And then making sure that you're setting your teams up for success to help improve, which I think is a huge theme of what you've touched on.

I just wanna kinda I know this is kind of a silly question after going through this presentation and and having you share your thoughts on each of these non avoided?

Yes. Yeah. Definitely so. I definitely think so. And I I work with a lot of customers who they have the organization has made compliance, a top priority.

And because of that, they have often or at least all of the the time because they're working with me, they have invested in a modern CMMS solution. They've invested in Limble, and we're building out these procedures and these processes to make sure that they stay compliant in the future as they grow, as they scale. And it I have many of my customers have undergone audits over the last four months, six months, eight months, twelve months, and they're very busy. They often cancel our weekly meetings.

They, you know, tuck away for a week or two as they dive into this audit, and it's a lot of work. But, I check-in with them afterwards, and and they've often come through with flying colors and been very excited about the way that they were able to move through that audit and how Limble and their solutions played a role in their ability to successfully navigate that audit. So, I'm always excited for them, excited for what we're building, excited for our twenty one CFR customers. They're they're great.

And as I mentioned, they're just they're doing a lot of cool things and and a lot of cutting edge industries, and I'm always excited to check-in with them and see how things are going.

Yeah. I love how you mentioned that. A lot of them will cancel meetings because I think that's just the life, you know, of someone that is in these industries, especially that's over the maintenance and manufacturing world.

It's busy and it's not it's usually not the same day to day or month to month.

And I I know what you covered kinda ties into this, but can you kinda just brief us on what this statement is really covering and and how it applies to those that may be joining us today.

Definitely. Yeah. So by leveraging a leading edge CMS software like Limble, organizations can improve the efficiency, effectiveness, and compliance of their maintenance operations and consequently ensure adherence to the conditions outlined by twenty one CFR. So beautifully put, as I mentioned, these customers, the organizations do need to make compliance a top priority.

They do need to invest in in their maintenance teams in a modern solution, but it pays off. They're able to track these important key, moments, these maintenance tasks. They're able to grow as an organization and grow as teams and departments. They're able to really pull a lot of this important information into a centralized location where where people have access to, and continue to build and and grow their their companies and their and their products and their manufacturing processes.

So, it's exciting. It's exciting to be moving into Limble or to moving into a software like Limble to bring your data in.

Often, the the people I work with, the teams are excited about how much simpler it makes their day to day, how aware and transparent transparent things like that. Everything just seems a little bit more attainable and accessible, and it it it's fun to help them kinda grow in that way.

Yeah. Okay. Thank you.

Now before we head over into the q and a, I just want to remind everyone of this survey that I mentioned at the beginning of today's session. I know some of you may have joined late. But, again, we encourage you to fill out the survey. It helps us to improve our future events and just make sure that you're getting the most out of every event that we possibly can provide.

But now onto the q and a.

Just as a reminder, how to get to the q and a, there is a q and a icon that you can click on at the bottom of your screen.

And just type your question into the text box, and we'll go ahead and jump in. There were a couple couple of questions, couple of comments that came in while we have been going through today's presentation that I'd love to throw out Chad and and get his thoughts on. One of them came from Anthony, and he made the comment that that they have a great CMS. But one of the issues that they're seeing is the lack of detail in the notes, or comments that have been done, other than just checking the required tasks.

So I'd love your thoughts on this from your experience. What can teams do to help have their teams provide more detail? Are there different things that they can maybe try to help get more information from their teams when they're completing those tasks?

Yeah. That's a great question.

Getting that detail can be hard, especially teams are busy.

You know, folk are are busy, and they have a backlog of tasks and things. But as you mentioned, Anthony, that detail is so important and sometimes, you know, very, very, important outside of just what was checked off or what was done. So in Limble, I can talk a little bit about what we can do or what Limble offers, but Limble does have the ability to, have a completion note section and make that required so that when a a maintenance tech is going through a task, sure, they can check off the four or five, you know, items on there. But with the completion notes required, they do have to fill that out, before they can submit the task. So there are options, and a lot of modern CMS CMMSs do offer options for capturing notes within Limble as well. You can, when a task is checked off, you can surface a, a text input box after that and ask for maybe more detail or a breakdown of what exactly they saw when they were doing that item.

So there's a couple of different ways to just add different opportunities for the teams to input more detail. Now some of that detail is is still gonna come through just training, and getting teams onboard to provide that detail because there's still kind of, you know, ways to maybe input general text in there and skip on to the next thing. So some of it will be training and general buy in, but, Limble at least does have a few tools there to try to capture some additional detail on maintenance tasks.

Alright. I know I'd asked a question and it said, can your system send alerts if the process is compromised or disrupted?

Yeah. That's a great question. So, by process, I'm assuming the actual, manufacturing process and maybe there's a, a clog or a stall or something's occurring there, and the process has been compromised.

Monitoring in that way, we do have we can integrate with sensors and monitors, and there are, different options that we can do where we can trigger alerts or trigger subsequent work depending on the feedback from those, from those sensors. So there definitely are some options if those sensors, you know, could feed in and we can pull the the data and key off that. We can definitely trigger some alerts or subsequent work from that. Limble also does have a very robust and flexible API. So there's a lot of options in there depending on what we're using to monitor the whether or not our system is compromised.

There is a lot of options there to push that data, to trigger additional tasks or things in limbo and get the ball rolling on activities if something is alerted. So definitely some options.

Perfect. Thank you. That's awesome to know. I know, just being able to have a system that can help in many aspects for these maintenance teams is huge. So having a robust API I think is a really huge key in that and helping teams just get the most out of the systems that they're currently using.

We do have another question, from Ed. Just how often is the software updated?

Yeah. Great question. And this, this this I can touch a little bit on what our validation process looks like for Limble. So Limble, we have a very detailed and concrete validation process, because it's twenty one CFR.

If you're at one of our twenty one CFR customers, we make sure that we do, significant validation that you also have a period of validation before any new changes go live. So to comply with that, we do have two release periods each year, May first and November first. And then the the few months before those release periods is when customers are alerted of any changes, bug fixes, new updates, future rollout, and then customers are given time and space to validate those changes within a validation environment, and then they go live on May first or November first. So twice a year.

Perfect. Thank you. I know we had another question come in and I think this ties into many teams, and kind of goes over the generation, turnover with workers where it says many of the seasoned veterans prefer to handle their processes a little bit more manually.

So how how adaptable is Limble to those who are trained with more manual processes. So I'm assuming this is relating to seasoned workers that maybe aren't as tech savvy. So, Chad, what are your thoughts? How easy is Limble to, you know, teach to someone that maybe is tech hesitant or prefers more manual processes?

Yeah. Another great question.

Limble is actually very user friendly.

I've worked with a lot of seasoned maintenance workers who have spent decades in the industry and who know their equipment, you know, from back to front, but haven't spent a lot of time within, you know, modern web applications or, you know, on a computer, or on mobile phone applications, things like that. And so there's definitely some hesitancy sometimes when we kick things off. It's new. We have to learn together, but they pick it up very quickly and almost, you know, around the, always there's a there's a point where it becomes second nature, and they realize the benefits, the simplicity, the efficiency, the time it saves, and there's always a little bit of celebration at that point when, when they realize just how valuable it is.

So, yeah, definitely something. And and when you sign on with Limble, you are we have incredible training resources, a customer success manager who will walk through and train individual group trainings. So there's an incredible amount of support that comes with, joining Limble and and investing in Limble, to make sure that teams do feel comfortable, don't feel stuck, and can get up to speed within with Limble as as quickly as possible. But, yeah, great question.

Perfect. Thank you. I know, again, there's, like, this shift where it's before there was things that were trained more, you know, by worker per worker, and now we have a generation that prefers things that are more streamlined, more techie. And so finding that middle ground, I know, is hard. So having a system, it sounds like that means both people or both generations where where they're at, I think is important.

We have another question that says, where is the data or document stored? Is it private private servers or cloud based?

Yeah. Great question. Limble is cloud based.

So your data, your documents, your images are stored on the cloud. They're available, through the mobile app, wherever you might be, through our tablets, you know, through your tablets, things like that. We also do have, we've recently pushed out some some big updates to our offline mode. So you can even do local system caches with your data and documents and then work offline. And then when you get, connectivity back, resync the work you've done there. So a lot of flexibility. Being cloud based provides a lot of flexibility with how we're able to support and service our customers.

Perfect. I know we just have time for maybe one or two more questions.

One of the questions that we have in here is, what does the typical data retrieval process look like during an audit or just from day to day?

Yeah. So that the data within Limble is very accessible. That's one thing. We wanna make sure our customers feel comfortable that their data is there when they need it, especially for reasons like this, an audit or, you know, if they're looking to investigate into, you know, happenings or something that happened.

So within each of the different parts of Limble, whether you're looking at PMs or completed tasks or your equipment, you can find your data there. You can look walk through the UI and find lists of all completed work as well as download or export that data as necessary to make sure you have everything available to you so that you can comply with any requests, audits, things like that.

So very easy. You'll see big old import export buttons all over the place.

We don't hide or obfuscate or leave you or leave without without access to your data at any point.

Perfect.

I think that is all for questions that we have today.

Thank you, Chad and to our sponsors at Limble. We appreciate your time today and for the content that you were able to provide, the insight.

We are excited to learn more about twenty one CFR. I think there's many industries, many, participants here today that took a lot out of it. For all of those that are joining or have joined today, we just want to remind you that within the next twenty four hours, you will receive a personalized follow-up email with details and a link to today's on demand session. Please feel free to invite colleagues or peers who may not have been able to join today that may be interested in the content to watch and, learn from Chad. This webinar is copyrighted twenty twenty four by Informa. The presentation materials are owned and copyrighted by Informa Markets. The individual speaker is solely responsible for their content and opinions.

On behalf of our guests, Chad Shurmur, I'm Mary Nelson. Thank you all for your time and have a great rest of your day.

Yeah. Thanks, everyone. Bye.

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