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How growing and mid-size Life Science companies leverage SAP Cloud ERP - [Webinar]

Good day, everyone. And welcome to our latest life sciences webinar here at Navigator Business Solutions, "How growing and midsize life science companies leverage SAP cloud ERP."


  • Kick-off: How Life Science companies are using SAP Business ByDesign
  • Demo: Electronic Batch Records with Track and Trace
  • Demo: Quality Management
  • Demo: CAPA
  • Demo: Recall Management
  • Demo: Product Restrictions
  • SAP Life Sciences Expert Q&A

Today's webinar will be presented by Kevin Brophy, Life Sciences Industry, Executive Advisor at SAP and Ralph Hess the Vice President at Navigator Business Solutions. Today's webinar will be a demonstration focused presentation. Kevin, will start off with a quick overview of how life science companies are using SAP Business ByDesign into a series of short demos, Ralph will then provide a quick customer story, and then we'll open it up for questions. Please feel free to type your questions in the, in your control panel during the presentation. And we'll get to them as soon as we can during the flow of the demonstration or the question and answer period at the end with that, I'll turn it over to Kevin Brophy and let him introduce a high level view of Business by Design and the life sciences industry.

Hey Sean. Thank you. So good afternoon. Good morning to everyone. Depending on where you're at. Yeah. So Business ByDesign a big myth about SAP is what Business ByDesign can do for our customers and with what with partners like Navigator has done to make ByD even more of a life science solution for the customers, with some of their IP that they put into it really makes it an excellent solution for couple areas, for companies, smaller companies that need to step into an ERP. But then also for large companies that need a second tier. So companies like Medtronic, Cardinal health live a Nova can't tell medical all, use it as a second tier for those smaller countries that they need to get onto an automated system. And the reason why you want to take a look at ByD here is first off multi-country, multi-company and multi-currency is built into the system and out of the box.

And that's why when I named those kinds of companies, I did, those are the kinds of things they need because of being global businesses. And that's what happens very quickly for life science customers. When I get a drug or I get a device and I start getting approvals, I quickly get the complexity to need all those global issues. And that's when the supply chain becomes very complex and I start to need to be able to manage it and understand what I have around the globe, identifying lot stock by lot and batch, including products in device that are registered with serial serial numbers, full embedded production supports for GMP, for both discreet and for process. So whether you're a farmer or a med device or biopharma solutions can absolutely has what you need embedded quality control for both device and for our biopharmas and bedded warranty tracking normally used by the device customers when they have a device that's out at the, at the hospital at the patient level, and the platform is ready to be validated and, and has been validated a validatable solution since 2015.

So a big myth there, as far as when you look at some of the competitors who still to this day, don't have a validated environment for a life science company, with their cloud solutions and some of the key compliance things, full track and trace for the batch and serial numbers user authorization and the login control. So the things you need for the FDA all the transactions are marked date, time user created it the change log for every document. So when some master data or document, when something changes we know who changed it when they changed it, et cetera, again, just CFR part 11 normal requirements, strong bond, revision control, and ability to support variants if needed and integration to quality management solutions. And, you know, we always use the CFR part 11. I, the customer requirements that are, that are adhered to, but I had a customer yesterday asked me, well, what about annex 11? Absolutely. we usually use CFR part 11 as the benchmark, since many countries, if not all countries, you see the US FDA CFR part 11 as the benchmark for their requirements.

Very, very good solution. And again, back for now, five years, we've provided a cloud validatable solution for life science customers. So at this point I'm turning it over to Ralph.

Great. Thanks, Kevin. Yeah, all your points are spot on and, and all the things that all of our life science customers really enjoy about the platform. And then we have customers that are, have been validated all the way back to 2015. So it's good that you're right. It is one of the myths that we constantly have to educate our prospective customers on. Let me go ahead and just we'll just, we'll, I'm going to go through is, is go through a series of demos. We'll, we'll take a look at product models or production models. We'll take a look at batch records with track and trace really batch records with with serialization as well. And then talk about what the options are there. We'll take a quick look at that. The, the quality management capabilities of ByDesign out of the box. So as, as Kevin alluded to, there is ready integration with electronic quality management systems, which is sometimes kind of what the, the, the heartbeat of some of our life science companies, as they're getting started up, they want to have their quality management system really kind of dictate the, what, how the documentation and controls that are going to be put in place into the ERP.

So the transactional quality management that by design provides, provides excellent support for that. We'll take a quick look at CAPA. So we do have a capital module, corrective action and preventative action. We'll take a quick look at our capabilities for recall management or that, of course, building right on track and trace. And then we'll also take a look at product restrictions

So let's, let's go ahead. I'm just going to exit exit the slideshow and, and get right into, into, ByDesign itself. So it says log into by design, and I'm not sure how many people have, or haven't seen it. Obviously I'll just start right from the very beginning where I'm going to log off. We talk about user log on controls. Obviously I had, since I do a lot of demos, I have a number of my passwords kind of stored. But I'm going to log on as an administrator, but each person as they have their role in the system is authorized to, to a different number of work centers and controls within those work centers. So as a system administrator, I have a lot of access, as you would imagine, I'm a super user on the system and it gives me access to the various work centers that are available to me out of the box through ByDesign.

So, and that's really a key element ByDesign is a, what we call a suite in a box, which means that you're not having to add on a whole number of different solutions and integrate them in the cloud. It's a cloud ready suite in a box that has all the options and features that you need to support your business process immediately on day one, let's take a look at my, my launch pad, which is what I'm calling this, the starting screen that I have here. I've, I've organized myself some, just some sections that make it very easy for me to walk through this demonstration, quite frankly, so I can either access it just quick navigation points. I can either access using navigating through kind of a menu option, and then you structure, I can create shortcuts for myself or I can build my own personalized watch.

That is that's what I've done today. So as I, as I worked through these, these various sections, I can go ahead and access the various sections that I have either by clicking on the section above, or I can go ahead and just access it by scrolling down through the screen. This, by the way, is an excellent environment for touch screen. All of this has touch screen enabled, delivered through a browser, really browser agnostic at this point because it's HTML five responsive design. And so it's, it becomes very easy to use on any device anywhere at any time. So not to have an advertisement about the platform. Let's go ahead and just drill into a little bit of data here. So what I want it to talk about, what's a little bit about, well, product data management, talk about production models and production builds, material production, goals of operation, and a little bit about change orders.

We'll find our way into registered products, which are serialized products identified stock, which more commonly known as where a lot track stock. And we'll get through a little bit of quality we'll look at Kappa action plans, recalls, and then head over to product restriction. So let's go into production models. Now, I think people despise design use the concept of a production model to bring together a bill of operation and a bill of material. And that provides a lot of flexibility in terms of supporting variants and production models of different variants of models. So if I want to go ahead and what are things I want to do first is just drill right into this product ID. As you can see the user interface, pretty easy claim. Again, as we're taking a look at, you know, anything that we have a a link to, we can drill into, so let's go ahead and just drill into this product ID.

And let's take a look at this particular item. What I meant ByDesign it always brings up a summary view of information. For me, it gives me that information quickly side. I have a little bit of a summary view of, of the, of the information that I'm looking for, but let me go ahead and expand things into a view, all which gives me an overview. That's just an overview, but the ability to actually get into the actual data, the details of the data as it were. So if I take a look here at the general information I have obviously product categories, but of specific interests when it comes to track and trace is I have identified stock, which is Lot traceability that I have different types of lot traceability, so I can have full lots, optional specified lots, or mandatory specified stock. So I have options that kind of meet my business process requirements.

I can indicate whether I have serial numbers and then this case, I don't have a serial number, but I can, I can assume I can assign different serial number profiles and how those get generated and how they get tracked as well. I can set up location restrictions so I can indicate that I have location restrictions. And we'll talk a little bit about that when we get to product restrictions. And lastly, I have product specifications. So I do have the ability to have this same product and have a varying number of specified versions of that product that I may have run a build for various customers or two specific formulas or versions of a particular product. So those are just a few elements. I'm not going to take you through a training lesson on the item master. But two of the things that I wanted to just touch on was the fact that we have our location restrictions here.

I also have quantity restrictions in terms of how much of this product I can sell over a given period, which then ties into how much I can sell to a given customer over a given period. Then the last piece that I wanted to just touch on was changes as Kevin had mentioned, all of those things that you need for 21 CFR part 11 in terms of logging of changes date and time tracking of any changes. And actually a, if I go ahead and just do a comparison between two, it will go ahead and tell me what the actual changes were. So not only do I have the date and time, who it was changed by what their user ID is, but I also have the actual, all of the data points that were changed on that particular record. So very strong in terms of understanding the license, you know, supporting the life sciences requirements you know, just good old fashion, ERP requirements, but support the life science requirements very well.

Now it's actually over to this production model. Let's go ahead and take a look at this particular production model. Again, bringing me to that summary view. Giving me a bit of information about the production model, its name, what site, you know, so what production facilities, this particular production model is in place for what the product is, what the segment, what the bill of material is, that's used, what the bill of operations that are used. And then again, that tracking right, who was created by who it was changed by and giving me some effectivity dating on this particular model, but let me go ahead and view all here. And this is just going to go and give me some information about that particular bill of operations. So again, the production model, bringing together the bill of operations and then the product assignment, which is the bill of material.

So if I go ahead and just say, I had a little bit of information about this particular bill of operations, again, when it was created, when it was changed a little bit about the structure itself, what products are assigned to this particular delivery operations and which step in the manufacturing process they're going to be used. And then a planning view of my bill of operation. This is a, this is a one step bill of operation. So there's that much to see here. But if we did have a multistep, we would go ahead and see the multiple steps. From a planning perspective, I do have control over releasing production models, opening release production battles, and, and maintaining an execution model as well. So it gives me a lot of, a lot of capabilities. And lastly, and certainly not least I have the administrative data of the who, what, where on any of the maintenance that was done on this particular production model.

I also want to just point out on the screen. I have the ability to be able to flag things, star things. So make them my favorites, if you will tag them and then add individual notes to them as I need. So as we take a look at the production model, pretty straightforward stuff. Let's close that up. And next step on the, on the tour will be a production bill of material. So I had the model now let me take a look at the bill of material for that particular, that particular item. As I take a look, I have two different, if you'll notice I have two different variants of the same bill of materials, but I can only have, like, I have to have them active or deactive. So this one is still in a planning phase, but let's go ahead and just take a quick look at it so I can do either select anything I can, I can, again, just click on the individual bill of material ID as I go ahead and take a look at it.

I can, I can see for this bill of material what the two variants are that are related to the biller material. So you can see that, that change that I made, that engineering change that I made to reduce the, to blank. It's still check pending, but if I want to go ahead and view all, I can see the general and the variance. I can see my input products. I have an engineering change order ID. I can have a reference date. I have, I can do filtering to gain better kind of a more restricted list of what's showing up in the detail here. And then down at the bottom, I have my item details changes that were made where, where this particular bill of material is used, if it happens to be a sub component. And then I have the ability, the system to be able to attach either documents, links to document management systems, et cetera.

So as I also look, I can see that I have engineering change orders are supported. So as I'm making the changes, I'm creating engineering change orders and documenting what it is done on that particular change order. We also have the ability to set approvals on those engineering change orders and take them through a workflow to enable you know, good controls over the implementation of those change orders. So that that's, that a little bit about filtering material in a little bit less exciting as probably the production bill of operations. Whereas we're taking a look here. The production bill of operations is really just speaking to what the routing the routing are. I can go ahead and expand that I can have on the routing. I can have different types of activities. I have a produce activity. I can have a quality inspection activity et cetera.

So as we set up, tear down, produce quality, those are the different types of activities that I can have out a bill of operation then again doing a view all I have the various information and to be able to do a planning view of where you are, et cetera. And again, if we look all of this is marked with dates, of who created it when it was created, who changed it, et cetera. And behind the scenes, there are constant logs being captive, any of the changes that are made to these particular master databases. So as, as we look at supporting GMP and, and you know, we're not going to get into the whole production process, that'll be a whole other webinar that Sean sets up for us. But we are establishing in controlling and tracking all of the master data or product data that goes into the production of a product and carefully controlling the design of it.

Let's talk a little bit about serial and batch lot tracking. And as you can see, I use the more, probably the more familiar words for this, but as we go ahead and take a look, I'm just going to drill into registered products. As Kevin had mentioned when you're dealing with either med device whether, you know, it's equipment or whether it's an actual device and whether you need warranties or not have warranties, et cetera, ByDesign supports all of that. So as, as we look at this particular, this particular product this was actually a customer of ours, said producing a tattoo removal piece of equipment, which was very interesting. They're still in very early stages. So as we take a look at their purchasing all of their product now but they wanted to get a solution in place that would allow them to scale into actual production themselves.

So something to understand about ByDesign is it handles playing it's very well in terms of either a third party logistics, outsource processing, et cetera. Let's go ahead and just take a quick look at, at this particular, this particular item, again, this is a registered product, which is a serialized product. So here's the serialized number for it. Unit's referring to a given product in a product category. UI also, by the way, can have serialized product that is lot controlled. So I can have that combination of lot and cereal on the same trackable entity as well. So as I take a look here, I have my, my registered product,uthe product description,uif there's a warranty, what the reference date is, if I, if there is some external registered product idea, if this was a purchase product, and I had to track it back to a registered product ID from a manufacturer, I could capture that there.

I can see who this has been sold to in terms of accounting contacts. So as we're, as we're going through, I can see who the involved parties are, who the custodian is, who the owner is from a tracking perspective. I can see the movements and I can see the movements. Actually, you'll see this as we get into the lot traceability, I can see actually internal movements within the warehouse as well, but in this case, this is just a purchase and sell type product. So I can see the date, what the movement was. So this was an inbound delivery. Again, if I want to drill into that inbound delivery, very easy to do, I'm just linking right into that. And I can go ahead and see any of the information that I want about that particular delivery. And I can see who the business partner was, et cetera.

So pretty straightforward stuff on the tracking detailed tracking. Again, if I had done any internal warehouse movements, I would see that listed here and again, my change squad capabilities and traceability. So I'm able to see and support any of the different types of research or tracking that I need to have on changes of user authorizations, or who did what to these, this information on what given date, at what time using what log on. And then we get to have my attachments. So if I had pictures of, of that particular lot maybe certificates of compliance, et cetera, that I wanted to attach, I could have that there. So that's, that's pretty much where we're at with the registered products. As we take a look we can assign warranties. So as products are being sold, if you're setting up various warranty agreements, those can be attached at the time of delivery and would be tracked here as well.

So that gives you a bit about the registered product. Let's no go into the let's go into the lot traceability, which we'll call identified stock. Again, lots are known as identified stock within site design. And so here I have an active lot. And as we go ahead and drill right into that, you're seeing that I have I go ahead and view all this is going to give me a little bit more information. So I can, I can not view all information about this. So I have the, the description. I have a production date. I have an expiration date. Then I have the production date. I have a particular description. I can have quantity, conversions, notes, attachments. And again, I have the changes to this particular lot. So let me go drill into this a little bit further,

So now as I take a look at, I can see more about the, about this particular product itself. So now I'm, and then I can see the information kind of that header information, but I also see where it is an inventory, what its status is. So I do have the concept of being able to have restricted product product that's in inspection as part of a quality inspection plan. And then I have the quantity that's in that particular status in that particular location within the warehouse. If I want to show the details, I can go ahead and get into a bit more of the details of what's gone on with that particular lot. So here you're seeing, and again, as I referred to earlier, and when I was showing the serialized product, that tracking of, of movement of product within the warehouse this is an example of that.

So as I take a look at the inventory details, I can see my confirmation items, confirmation, meaning a completed transaction within ByDesign. So here we are, we, we made this product on the 18th of May as part of the demonstration that we did in preparing for my demonstration. I moved some things around, I actually restricted some of the products. And then I did a pick for a sales order, and then I actually issued it as part of the delivery. And then as we take a look, here's the delivery that it went out. So as you can see, I can, I have all of the information that I would need to be able to do a full trace both forward and backwards, and also be able to do a recall if necessary, we'll get into that in just a few minutes, as we're taking a look at any of these, again, unable to drill into the particular transaction and take a look at the confirmation journal, if you will confirmation journal being the, the actual transaction of what happened. So you know, here, I'm doing a pick I'm pulling it out of a particular area. It's a good issue onto a particular sales order, so no financial impact there. So I don't really have a confirmation journal, but anything that actually has a financial impact, I can go ahead and see the confirmation journal and what, what account it hits. So here I'm getting kind of what some people would refer to as a stock posting for that particular, that particular identified stock item.

So that, that gives us a bit of information about the detailed level of traceability that you can have within, ByDesign very strong in terms of being able to support validatable type processes. So let's now move into the area of quality. Now, as I had said, many of our customers use kind of an external full blown quality management system. Something like Master Control it's for instance is, is one of the, the solutions that our customers use very robust quality management solution that we have done some integrations with, but within, by design itself, it does have the ability to have you set up inspection plan. So you do have the concept of being able to set up an inspection plan and there's varying types. So I can do it. I can create in-process inspection plans. I can do final inspection plans.

I can do receiving inspection and outbound shipment type inspections as well. And as, I take a look at that. If I go and look at perhaps this particular inspection plan, just to give you a little bit of a, an idea of what the anatomy of them are. I have the ability to go ahead and create an inspection plan associated with the product. I go ahead and just go into edit here, but it will make the screen a little bit more readable. So it's, I take a real kit, I have an inspection scope, so I have different scopes that I can set do not categorize, you know, do I want to, as I'm inspecting this stock, categorize it as inspection and make it not available to promise to the law, do I want to print inspection instructions automatically? Do I want to print sample drawings automatically?

So this is saying that when I, when I go ahead and actually create an inspection off of this plan, what behavior do I want the system to perform? Now, I have my sample data where I'm setting up my sampling data, what my evaluation mode is, what my inspection duration per sample is. So it's starting to set up some of those standards setting up different quality codes. So as we take a look at the, what we have in our demo system here, we have different quality codes which are possible inspection dispositions, or deviation I have against that changes. So if there's been a change made to the inspection plan, looks like at this point, it's just an actually created by Richard Stone. And it's an awful lot of work in our system here. But this again has that whole foundation of keeping track of any changes.

I have my notes. And then again, I have my attachments again, attachments and notes riddled throughout the system to allow you to be able to document. And then you'll see up here that same concept of flag, star tag and notes. So that gives you a little bit of an idea of inspection plans that you can set up. And then as you, as you work, you can have them be at various points in your in process. So as part of a production process at the end of your production process, or again, at the point of receiving you have those triggers and configurable triggers that you can set within the system to actually initiate inspections. So as I look at inspections and I take a look at a given inspection, I can take a look and see that you know, I've got, I take a look at this guy here.

We have a final inspection from production. So if I wanted to, and the way this works, by the way, I'm sorry to digress a bit, but by design is a very task oriented system. So as let's say that somebody is completing production or reporting production, and a quality inspection gets triggered well, that quality inspection is going to be put in a folder and become part of somebody's open items or open tasks that they need to accomplish. And so people are driven in using the system by kind of a task orientation, always having that list of work, especially an operator or somebody who's in a kind of a task type position, our size, the ability to keep track of their open tasks open items words that they're getting as they're, as they're working through their day.

As I look at inspections, and as I go into this particular, this particular inspection, you can see that I just pulled up this particular inspection. I'm not in task mode, but I really have an overview of what this particular inspection is. So it's, it's telling me that you know, there's a lot quantity of 1,020 pounds out there but size and it's, what's what the sample size, what the evaluation mode is. You know, you need to go ahead and evaluate it. So again, this is tied back to an inspection plan and this then can be assigned to a person. And as they're going through, when they're actually recording or recording or confirming this particular inspection, then they can sell, go ahead and, and actually recording any of the defects again don't want to get too deep into actually doing transactions.

Just want to talk more about what, what they're about, but as we're doing our, as we're actually recording, we have we're recording total number of defects. What the decision is, what the score is, what, who, what was decided on what date and who was decided by. So as I, as I take a look at editing this, I can, this is where I can go in and actually record my results, record my decision record, miscellaneous information about, about it. And as we take a look, it gives me a little bit of the document flow. So something that's very strong, again from a track and trace capability in the system is that every transaction, every document has kind of a ancestry to it, if you will. So, as I take a look here, it came from a production request, came from a production order, and now it's generated this particular inspection.

As I take a look, I can go ahead. I have my changes history again, again, I would expect this is just been generated, but it's, if that inspection had been changed in any way, then we would know it. And as we look at any output history, any documents that were printed, et cetera. So as we take a look at that, go ahead and close that as we take a look at the inspection that's something you can do on a handheld, something you can do on a tablet, I can be barcode enabled, et cetera. One last piece that I wanted to just touch on here is that you'll notice that there is a link to the, to create a CAPA case. So if I'm in the middle of an inspection and I want to create a CAPA case, I can go ahead and tap on the button and initiate my CAPA case, right from the inspection itself. So very, very integrated in terms of inspections from CAPA.

Speaking of CAPA, let's go, go visit on CAPA for just a few minutes. So as we look at CAPA, I don't have any active cases myself, but let's go ahead and take a look at the cases that I have. So as we, as we take a look at the cases that I've had, as I've been doing some, some demonstrations over the course of time, we just opened up a CAPA. We'll take a look at some of the information that we capture and the process associated with it. So as we look at this particular CAPA case, I have a case ID. I have a status, I have the owner of it, who it was reported by. And then I have what information I'm going to capture at the point of initiation. So I'm going to, I'm going to give it a title. I can give it an external ID.

So if this had been initiated from one of the inspections, the inspection ID would be there. What the CAPA type is. So in this case, it's supplier it's against some material. The source of it was, we did, we're in the middle of a material inspection. We reported it on the 21st of January and it occurred on the 21st of January. So that's when we, we identified the defect, we identify the particular product. We understand who was reported by if it was reported by a customer or if it was reported by a supplier. And then we can set investigation due dates, implementation due dates and completion due dates, all of which are reportable so that you can keep track. And we have the whole process be very accountable. As we take a look, we're tracking the completion date. So as we're going through our risk assessment, as we're going through our investigation, as we're going through our implementation, and as we're going through our review we are actually going through and capturing the dates and times in which things were completed.

Obviously this, I did this during a demo, and this was all closed out in the course of a single day, so very efficient, but as we take a look at risk assessment, we assign a security rate, severity rating and occurrence rating, and detection rating what the rationale was what the mitigation plan should be, whether containment was required. And then at that point, we can, when we're through with our complete initial assessment, we go ahead and click the initial assessment button, which then brings us into the investigation. And so we can have during the investigation, we can identify the root cause of, of the particular problem. Again, all of this being backed up by a set of tables with,uwith standardized coding in terms of root causes,uroot cause percentage failure, Modes, et cetera, I then can do an implementation so I can have,uI can have action plans that I, that I go ahead and create and assign to,uto this particular CAPA.

So we're, we're going to go ahead and fix it and fix it again. So I can have multiple action plans associated with my implementation. And then we can go ahead and do a review. And basically the review was, is, you know, sitting in your, your CAPA review board, everybody looking and agreeing that this was an effective corrective action and in a proper preventative action plan that's been put in place and they're basically signing off on it. So that really covers off the whole completion dates and the cycle of a corrective action plan. As we look at the change history, again, anything that's been changed on this particular, this particular case is going to be tracked in detail with the, what, who and why.

So that covers up a little bit about CAPA. As, as I mentioned, the action plans themselves are you can go ahead and create your own action plans within the system. So if I were to edit one, I can go ahead and edit this. I can create, create an action give it a name, a type we can assign it to given people. We have actually our, our data, et cetera. We have descriptions, we have results and then attachments as well. So very, very flexible in terms of, of setting equates the proper documentation to be used by the, the CAPA module itself.

Okay. Let's take a look at recall. So as, as we're doing either, you know, through the course of our business, if we decide, we need to do a recall we can certainly do that. And this is a good way to quickly identify and isolate product that needs to be what we call the system blocked or frozen for purposes of recall. So this one was related to CAPA 2020 - 4. So if I take a look at it and if I go ahead and edit it, I can see that as part of this recall, we were, we're recalling two different products with a particular stock IDs or identified stock, lot numbers. And as we did the research at it, we saw that they had been delivered on delivery ID, who it went to the date, the time, what the outbound delivery number was.

So we know who we need to go retrieve it from. I can understand how much of it I still have in stock and where it's located. So I can go ahead and do what we call a change of stock in order to go ahead and freeze or block all the stock. So if I click black, all this stock, all of this stock would then be put in a restricted state, which means it's not available to promise it's not available for stock movement other than a very distinct change of inventory status notification. And then if I had any in production, it would be listed in production as well.

So hopefully you're seeing that with ByDesign and these various modules we're pulling together a full blown solution, a full blown platform that satisfies all the requirements, not just life sciences, but really regulated industries that have a concern over, over traceability, accountability and meeting certain regulatory requirements. The last part that we'll visit here, as we'll talk about product restrictions and sort of product restrictions, we have both supplier and customer levels, product restrictions, or product approval. Shall we say interesting that we use the word restrictions and then listed as approvals, but as I take a look, you know, I can, I can go ahead and, and what supplier IDs I'm going to buy, what products from. So if I go ahead and edit this, I can indicate whether I'm approved or restricted from buying particular products from a particular supplier. This then goes really to to your ASL or your approved supplier list.

This is the way that you can support that within the system and ensuring that I'm only buying the right products from the right supplier. I'm not done, not from a regulatory perspective or a quality management perspective, not violet violating any of the authorized supplier list restrictions that I might have. So this is, you know, again very straightforward to a very straightforward list. And then as I look at my customer product, it's very much the same thing. Who can I sell, what product to, and in this case it expands a little bit because within having product restrictions on the outbound customer side, there may be certain lo cals or localizations or shipped to addresses where I can, or can't sell products. If you take a look at, you know, if I take a look here cannabis today, but somebody were shipping a cannabis product, it may be legal to ship it into some States and not into others.

So this is what this is really accomplishing this concept of being able to indicate whether it's approved for sale to a customer at a given ship to address whether it's restricted and whether it's location restriction. So, you know, if I didn't have that, that, whether it was restricted for that product, to this customer, regardless of location, I would not have a location restriction in this case. I can sell this particular product to this particular customer in all locations with the exception of this particular location. So again, kind of the, in terms of, in terms of the controlling product and where it can be. So that's, that's going to give you the capabilities of being able to control that really, you know, kind of wrapping into your, your, your quality management system. As that quality management system is the overarching control, those controls, then at least it's documentation of those controls and the ERP solution via ByDesign at this juncture. And what we're showing you today is how you implement those controls. So that's, that's what I had in terms of demonstration. So hopefully people found that interesting or illuminating. And at this point, Sean, I guess I'll kick it back to you to see if there's any questions that might have come up.

You got a couple of questions. We're trying to keep this as promised to less than 40 minutes of your time. I have a couple of questions. If any of the other attendees have questions, please just type them in. Let's, let's go. We use contract manufacturers, eh, that's the second, actually, this is two two different attendees have asked, I'll read this one. We use contract manufacturers, can this be tailored down and not purchase complete system? What is the level of training and continued support? Does it generate labels such as UDI and shipping? So again, we have, and we have another one. How well does this work system work with contract manufacturing? And

It seems like a theme, doesn't it?

Sean it does sound like a theme. So it works extremely well with contract manufacturing. So in, in either in either the scenario where you're purchasing the complete, you know, end product from that contract manufacturer, or if you're consigning inventory out to them and their contract manufacturing, and then you're both wanting to control the, the input products of that contract manufacturer and the output product. So the answer is, yes, we actually do have an outsource manufacturing module, depending on the level of complexity that you want to go to, if you're purchasing the completed unit. Absolutely. That becomes what we call more of a logistics play, depending on whether you need to have you know, bill of material controls engineering control over designs, et cetera. It's just a matter of scoping the right portions of the solution in, as you look at my screen, there's this, there's a lot of different work centers and, and really the, the implementation is a matter of understanding your business and then turning the right switches on to activate the configuration that's required.

And, and again, that navigator not only implements SAP Business ByDesign, but we have ongoing support, both ongoing support consultants, as well as direct support, telephone, email, and chat support for our customers to to address the continued support training and support question. And then does it generate labels such as UDI and shipping labels?

The answer is absolutely.

There is a complete report writing a module within the the application and can be used for generating labels upon receipt, et cetera.

So let's see, what are the other questions being what if we're in clinical trials and not yet commercial production, how to divide design fit in that into clinical trials? Not yet commercial production.

Gotcha. Gotcha. Yeah. So that's a great question because, and it's one, we have a lot of experience with, we have a number of our customers are, are early stage startups and they really kind of, you know, they outgrow QuickBooks and spreadsheets because really, as you're getting into clinical trials and you're starting to need to control more aspects of your business, that's where you need to get into a real system. So yes, you can with ByDesign, you can implement just, you know, what we actually have a partner package it's called a or a solution package called pre-revenue clinical trials. And what that is is it's it's financials with a heavy dose of project accounting and a bit of procurement. So what that allows you to do is, is be able to do, you know, obviously run your financials. And in many cases, these clinical trials are spanning countries. So the whole deal with, you know, being multiple-country multi-language multi-currency as being a foundational strength is, is a great aspect for those companies. So, yeah, we've, we've taken a number of those companies from the point where they're in clinical trials, all the way to commercialization all the way, frankly, to being acquired by one of the large, big pharma companies. So we're, we're very experienced at each stage of a life science company and have the right size configuration of the solution to apply to the various types of those businesses.

We're coming up on our 40 minutes with what I let's grab one last question. Are there problems validating the process since SAP Business ByDesign is cloud based ERP?

Yeah. And I think that Kevin addressed that a little bit. I know Kevin had to leave for another meeting, but yeah, the the ByDesign platform has been able to be validated, right? It's it's a validation ready platform. No system is validated it's validation ready. And then the software that runs on it is validated. But needless to say sometimes when people get concerned about within the validation

Process is revalidation because in the crowd you're using software that is in the case of by design updated on a quarterly basis. And since that, since the, those are concerned that there needs to be a revalidation every time there's an update to the software and that's not true, it's only if it, if you measure it, if you take a look at the changes that are coming to the system, it's a an evaluation of materiality of how much it changes. What's been validated with the majority. I can't say all, but the majority of the updates from ByDesign are additive to the existing business process. So the need to be revalidated is, is very, it's very infrequent. Great. So Ralph, that covers the, the three main questions that were asked during this session, I don't want to take too much of the attendees time.

We promise them 40 minutes so they can get back to work and and their day, but I wanted to for Kevin and Ralph and myself, Sean Barbera, the director of marketing here at Navigator Business Solutions. I want to thank all the attendees that joined us today. We, we continue to have these webinars focused on the life sciences industry, and we hope to see you in a future webinar, as we dig deeper into the details of supporting the life sciences industry and the companies that support it. So with that, I'm going to say, thank you, enjoy your day. And we hope to see you soon. Thank you very much for your time.



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