openSAP SAP PLM in Process Industries Week 1 Unit 1

00:00:04 Hi, welcome to the openSAP course for SAP PLM for Process Industries. My name is

Srivathsan Govindarajan and I head PLM product development at SAP.

00:00:13 I really look forward to taking you through PLM for process industries at SAP. We have a very interesting and compelling goal structure planned for you.

00:00:22 Week one, we will focus on an introduction to SAP's PLM for process industries, of which my talk here is the first chapter we do.

00:00:32 We will move on to the idea and concept phase of product development. We focus on collaborative product development in week three, and finally,

00:00:41 in week four we move on to the finalization and the process of handing over recipes to manufacturing.

00:00:47 It always starts with the big question, what do consumers want? Consumer requirements are constantly changing,

00:00:54 seasonal or unique flavors and custom sizes with personalized logos must be developed, manufactured, and delivered to consumers.

00:01:02 Process industry manufacturers must develop new innovations to the market constantly, driving and reacting to the changing consumer needs.

00:01:11 The winners on the market will take this opportunity and act faster than competitors.

00:01:17 Consumers have more and more interest in the products and ingredients they buy, and now the information is more accessible than ever before.

00:01:26 They want to know what they are buying and they are more engaged, willing to share their views and ideas.

00:01:32 Health and environmental concerns also increase. This becomes a driver of product development,

00:01:37 giving a good opportunity for those who can react quickly. For others, the constant need for change remains a difficulty.

00:01:46 One of the driving trends that requires SAP and companies to act is the change of consumer behavior.

00:01:53 We find and expect information to be everywhere, and we know much more about products than we did before.

00:01:59 People become more and more engaged and even open to sharing their reviews, influencing others and companies.

00:02:06 The winners in the market are the ones who take this opportunity and act faster than competitors.

00:02:13 The next big question is what does your R and D department need to do to address consumer needs?

00:02:19 To meet the unique needs of your consumers, you need to listen and understand their

00:02:25 requirements carefully and take it into consideration in the upcoming innovation cycles.

00:02:30 Innovating products and incorporating changes effectively in upstream and downstream processes is required to adapt to this fast-changing environment.

00:02:40 And this does not only enable teams to work more effectively, the whole extended enterprise must be involved throughout the development

00:02:48 process, including suppliers, artwork, designers, or external manufacturers. But how can companies support their R and D department to achieve these goals?

2

00:02:59 How do they enable teams to continuously drive innovation and bring successful products to the market faster than ever before?

00:03:07 How do we understand customer needs, set requirements and targets, and formulate the right products?

00:03:14 Step one, gather customer needs, collect and analyze customer feedback. Product managers must be connected to their customers and consumers.

00:03:24 To develop successful products, they need to know how customers see their product and what are their top priorities.

00:03:32 Gathering and analyzing experience data can lead to requirements in R and D. With feedback management, users can, A. retrieve feedback data to gather market

00:03:42 responses, B. manage, categorize, and consolidate feedback, C. generate a product requirement for each

00:03:49 consolidated feedback item, and D. unique integration approach, so linkage to requirements model throughout, through EPD engineering.

00:03:59 With these capabilities, they can, A. develop new products that consumers want, B. get competitive insights and answer rapidly to market demands,

00:04:08 C. improve product design decisions based on customer feedback, and D., through EPD engineering, we are offering several input channels via Qualtrics

00:04:18 and others that can be used to acquire new feedback to the product. Step two, formulate new product recipes to meet new requirements.

00:04:29 Later in the process, the product developers need to formulate new recipes that meet market requirements

00:04:35 they can do more effectively and efficiently, gaining a complete overview on the recipe structure and composition at once.

00:04:42 They can formulate products while checking the calculation results of each ingredient simultaneously.

00:04:48 With SAP Recipe Development, Contribution view, being a part of it, users can, A. get a hierarchical overview of the recipe formula

00:04:57 and process at the same time, while fine tuning the new formula using Contribution view in target-driven recipe development,

00:05:03 B. see each item's contribution to the final product, including cost, nutrition values, and composition,

00:05:10 C. create reusable user-specific layout by use case so that they can get direct insights while creating and changing the recipe formula,

00:05:18 getting a complete overview on the contribution of each component and stage. Now the key question is how do we innovate

00:05:25 products and incorporate changes in upstream and downstream processes? Step one, process and project-driven leveraging all resources correctly.

00:05:35 Without portfolio and project development, mostly all projects will be out of time and budget.

00:05:40 With SAP portfolio and project management, companies can invest in the right projects by aligning your project portfolio with enterprise strategy.

00:05:49 Basically, this means doing the right projects and projects right. Users can, A. manage the resource schedule

00:05:55 and finalize performance for each project phase from initiation through closure, B. manage tasks, timelines, track projects and profitability, access project information

00:06:06 through role-based user interfaces, and D. reduce new products, services, commercialization cost by offering insight into portfolios,

00:06:14 health, and status and comparing planned and actual budget deadlines. Step two, integrated with downstream

00:06:22 processes, for instance handover manufacturing. As a last step of the product development or change processes,

3

00:06:28 data from PLM needs to be synchronized with the manufacturing. During this synchronization,

00:06:32 certain conflicts may come up, such as rounding of the values. This is being resolved while being assisted by the framework.

00:06:39 The key highlights are, A. handover recipes from design to manufacturing, B. side-by-side display of source recipe

00:06:48 and target bill material or master recipe during handover, C. resolve conflicts during synchronization.

00:06:54 The key benefits are integration from product development to downstream processes and making handover decisions

00:07:01 by identifying conflicts and proposals by the system. Now the next question that we need to ask ourselves is how do we manage product

00:07:10 labels and work with external suppliers, designers, or team members? Step one, with labelling and recipe

00:07:16 development, S/4HANA, companies can reduce the time and complexity of developing the right product declaration with digitized labeling process.

00:07:26 Labelling helps companies declare the legally required properties of a product and also provides a platform to inform consumers on the health

00:07:35 promoting or other positive effects of the product. As part of the new product development

00:07:40 process, the label expert needs to start the product labeling process and declare the ingredients, nutrients, allergens, and add an additional statement on the product.

00:07:49 One of the most common causes of food recall alerts is mislabeled products, including undeclared allergens.

00:07:56 So the label expert needs a tool that supports his or her work. The key highlights are, A. create product

00:08:03 label sets based on different data sources, B. select multiple target location

00:08:08 and language combinations for the declaration, C. flexibly define the ingredient list, declare all allergens, and create nutrient

00:08:16 list for various quantities and predefined structures. The key benefits are, A. reduce the label creation time, by reusing the product

00:08:25 information calculated or maintained in the recipe development, B. develop ingredient label flexibly,

00:08:31 C. reduce the risk of non-compliance with digitized labeling process, and D. directly see the outcome of the work by generating a printout.

00:08:39 Step two, collaborate freely, both internally and externally. With regards to internal collaboration

00:08:45 to help with the teamwork, the product manager invites all team members to project collaboration, and they share all important documents,

00:08:51 even product data from the ERP system. With regards to external collaboration,

00:08:57 once they recognize that the requirements cannot be fulfilled with the existing ingredients, they initiate a supplier

00:09:02 collaboration to get the necessary information. Also leveraging workflows and Ariba integration.

00:09:09 Key highlights are, A create collaboration workspaces and invite participants, B. create multiple collaboration types for different purposes,

00:09:19 C. invite single participants or a whole user group to a collaboration via e-mail, D. invite your suppliers into a collaboration

00:09:28 from SAP Ariba Supplier Lifecycle and Performance. Disbenefits are, A. role-based collaboration,

00:09:35 provide authorization to different stakeholders, B. workflow-based collaboration,

00:09:40 which facilitates quicker communication amongst everyone. And now a quick overview of the SAP Digital Supply Chain portfolio.

4

00:09:49 SAP Digital Supply Chain portfolio contributes to the success of SAP product engineering.

00:09:54 For success, it is key to motivate and enable customers moving to S/4HANA. Combining the strength of S/4HANA in digital supply chain helps customers

00:10:03 define the value proposition for the move. SAP S/4HANA in digital supply chain solutions.

00:10:10 Customers can run their business processes end to end through sales, finance, procurement, and supply chain.

00:10:16 With the design-to-operate scenario, digital supply chain provides customers advanced capabilities to plan, design,

00:10:23 manufacture, deliver, and operate their products. In addition, digital supply chain is a key contributor

00:10:30 to lead-to-cash and source-to-pay scenario, through integrated processes with S/4HANA and C/4 HANA,

00:10:36 for example, triggering invoice creation when goods get shipped from the warehouse or identifying suppliers in the early design phase of a new product.

00:10:47 With that, SAP can address various buying centers with our customers, ranging from CIOs to business stakeholders like head of logistics or manufacturing,

00:10:55 driving adoption of our solutions. Digital supply chain contribution to SAP success.

00:11:02 Customers want to rapidly transform data into insight and action. We contribute to the Intelligent Enterprise with the design-to-operate scenario,

00:11:10 leveraging industrial Internet of Things, also called IoT, technology, blockchain and machine learning infused in supply chain business processes.

00:11:20 Using these capabilities, customers take automation of business processes to the next level and innovate their

00:11:26 business models moving from selling products to delivering services, for example, from selling compressors to offering compressed air as a service.

00:11:36 The market for supply chain solutions moves clearly to the cloud. We continue to move

00:11:41 to the cloud across the portfolio with integrated business planning. Digital Manufacturing Cloud,

00:11:48 intelligent asset management, transportation and warehouse management. And finally, from a BLM perspective,

00:11:56 Enterprise Product Development, which also consolidates intelligent product design offerings. As a great customer experience hinges

00:12:03 on a delightful product delivery and service experience, we contribute to the experience company

00:12:08 by, for example, integrating Enterprise Product Development in Qualtrics for leveraging customer feedback in the design process and linking

00:12:16 integrated business planning for improving forecast accuracy. The next question that we need to ask is how does SAP PLM provide

00:12:27 end-to-end process support? Product Lifecycle Management from initial

00:12:31 ideas to handover to manufacturing helps companies to shorten the innovation cycle and manage and develop innovative, compliant products.

00:12:40 With Innovation Management and Portfolio and Project management, we manage ideation,

00:12:46 targets, portfolio, and projects on a single platform. With Recipe Development, we digitize product formulation and development.

00:12:56 With Development Collaboration and Requirements Management we innovate products with design and supplier collaboration.

00:13:06 With Product Compliance, we ensure product compliance throughout the product's lifecycle.

00:13:11 With Handover to Manufacturing, we support product development end to end. So this is the objective we want

00:13:20 to achieve with desire's delivered in the experience economy for R and D, and this is done through customer centricity,

5

00:13:28 total visibility and accelerated innovation. With customer centricity, we enable individualization across

00:13:37 multiple domains and support the expansion into new business models. With total visibility,

00:13:43 we meet customer and market needs and ensure compliance and reduce cost with digital product development that enables a single source of truth

00:13:51 and provides data insights and analysis. With accelerated innovation, we deliver innovative and compliant

00:13:59 products faster with integrated digital formulation that accelerates product development processes and ensures seamless handover to manufacturing.

00:14:09 Finally, what did we learn in this course? One, R and D department needs tools that support its daily work from idea

00:14:17 and project management to handling or the new recipe to manufacturing. Two, the product development

00:14:24 or design phase as the first step in the product lifecycle and in the end-to-end digital supply chain process, from design to operate and design to consume.

00:14:33 Three, SAP Product Lifecycle Management supports the process of developing new products in discrete and process industries.

00:14:42 Thank you for your attention and enjoy the rest of this course.

6

Week 1 Unit 2

00:00:04 Welcome to the unit two of the openSAP course SAP PLM in Process Industries. My name

is Juergen Scholl, I'm the responsible product owner for PLM for Process Industries

00:00:14 and the chief product owner for Recipe Development. I will guide you through unit two of this course.

00:00:21 But let me do a short recap of unit one. I think in unit one, you have heard about the customers market segments,

00:00:29 expectations from consumers, from the markets, and also how this integrates with the SAP Digital Supply Chain portfolio.

00:00:38 In this chapter now, I will give you a high-level overview of the different solution capabilities, how they need to integrate and what's the

00:00:49 relation between it, and how they are reflected in this course. But let me first start on the challenges.

00:00:58 One challenge, innovation cycle. The speed of innovations increases continuously,

00:01:09 and it's a competitive advantage. So that means also your company needs to

00:01:16 manage that and reduce the time of innovations. As well, the products.

00:01:23 The product lifecycle gets shortened. So that means you have less time to

00:01:28 develop your products and you can sell it only for a shorter time. And maybe even this product has not arrived at this end of life already.

00:01:41 The success or product comes up to the market and needs to be developed, so that means also you have, in parallel, multiple

00:01:53 product developments, which may partly overlap and consume resources. You need to manage your product margin.

00:02:02 As I stated before, the lifecycle of the product gets shorter.

00:02:07 So that means to keep the product margin or get better, it is essential to lower the development course, to be more streamlined

00:02:19 in the development and at the end also to optimize the production costs. Teamwork.

00:02:26 Products are more and more designed for multiple countries, maybe even worldwide. So that means there is not one person, one team with all the knowledge, you need to

00:02:38 involve different teams in different countries into this development process. Firstly, they need to collaborate on it.

00:02:46 They need to have the same information. And these teams are not ending at your company's border.

00:02:52 They also include your suppliers and your customers.

00:02:58 You have to exchange with them about the product, what is the current state, what do you need from them, and so on.

00:03:05 So here, teamwork and collaboration is essential. That's the challenge.

00:03:12 Quality. There are two types of qualities.

00:03:15 One is you have your product defined and you want to validate in the production the quality, the measures.

00:03:26 Therefore, you need one single source of truth of your information so that this information from the R and D product definition is taken over in an

00:03:39 integrated manner, seamlessly into the inspections in production. But even in the R and D,

00:03:47 as I stated before, you are working in distributed teams, you need one single source of truth, and this is worldwide.

00:03:56 And this is not only about the finished product, it's also about the raw materials and so on.

00:04:02 You have agreed suppliers for different countries. This information needs to be centralized

00:04:07 so that you have one source of truth and everybody works with the same information going forward then, let me a little bit

7

00:04:17 talk about the holistic product development process. There are different phases inside and there are different

00:04:28 targets and activities to cover this. You have the idea and project phase,

00:04:37 where ideas get created, portfolios get checked, and then finally, the decision is made to set up a project to develop the product.

00:04:46 Then, the concept needs to be set up. Trials will be done to validate if such a product is possible

00:04:56 and how it can be achieved in the best and cheapest way possible. Here is an overlap, clearly with the formulation.

00:05:06 So if you develop concepts, you can do that by purely doing trials. But this is expensive because you very

00:05:16 often have expensive raw materials, which you consume even in the trials. So if you can formulate recipes and the

00:05:23 product also in an electronic manner, you can already pre-check the results, and if they are far out of range, why should you do a trial for it?

00:05:37 So, an electronic manner of developing recipes can save money by reducing the number of trials or

00:05:49 by accessing existing recipes to use them as a starting point. So a lot of pre-work can be skipped and

00:05:57 only the Delta needs to be developed and validated. And if you have your product defined, you need to generate declaration information.

00:06:10 But for that, you also have to check about compliance. Compliance here means, on the one side, legal regulations,

00:06:18 but you have also your own company, own rules, and your customers give you targets that you may need to fulfill.

00:06:25 So this needs to be checked. You can do that at the end of the development cycle,

00:06:31 but then you run into the risk that you need to go back if you missed something. If this already happens during formulation,

00:06:42 so that there our recipe developer already sees, oh, this ingredient includes a component that is not allowed in one country

00:06:51 out of the five countries that this product is designed for, then he can already remove that and don't go ahead with wasting time and money.

00:07:03 And then, this product definition then needs to be adjusted to the different

00:07:12 production locations and so on, and hand it over into the manufacturing, and this is best in a seamless manner so that no information

00:07:21 gets lost and it's aligned with the R and D. And at the end, okay, then the product launch information

00:07:30 for the marketing and so on to bring the product on the market. This is subdivided into different activities, processes, let's call it like that,

00:07:41 which partly also reflects also different functionalities. One thing is you need to handle your innovations, your ideas, manage them,

00:07:50 and aggregate them, put them together, make decisions if they fit into the portfolio. And then decide, okay, yes, we want to do this product.

00:07:59 And then you have to set up your project, your process, your gates, development gates, and targets in the results.

00:08:08 So you start with the product definition, with a brief, and then this gets handed over.

00:08:17 That means you start, as well, to collaborate. You need to collaborate with your suppliers, for example, to get a new raw material

00:08:25 which fits to your needs, so that you can design your new product. And you need to integrate your other departments as well into this information

00:08:36 so that they are up to date at any point in time, where you are, what's ongoing. When you develop your product, you get the product properties.

8

00:08:49 This needs to be stored in specifications, but you also have raw material specifications,

00:08:56 which describe the information you got from your supplier about the raw material, what components it includes, what nutritional information it includes.

00:09:07 And as well, you get documents on the one side from your supplier, for example, the certificates, which need to be as well

00:09:13 linked to the specification and managed in the system so that you can pick them out at any point in time when an auditor and so on comes.

00:09:26 And now you need to put together your product. So here recipe development is the central activity,

00:09:34 on the one side to formulate your input items, to define what goes into the product, to have the semi-finished or finished product.

00:09:44 But as well, the process definition, usually pointing out the key factors or key parameters of a process that need to be taken into account

00:09:58 also in the later production, otherwise the product may not fit to the targets.

00:10:02 If you may make changes in the process, then you have to do quality measures.

00:10:10 You do that in the trial process, where you validate your mixtures against your targets.

00:10:19 But you also, later on in production, you need to check this information against the R and D definitions.

00:10:32 Procurement is involved, and the earlier you can involve them and include them in the process, the better.

00:10:40 So, if you are a developer, discuss with a supplier about the raw material, what you would need.

00:10:50 And then the decision is made, okay, this is the right raw material. Then procurement can seamlessly take over if he is involved in this process.

00:11:04 And as I already stated in the process above, compliance. And not only compliance at the end of the product,

00:11:12 also compliance during the formulation of the product development is key, because this saves time and money.

00:11:20 And at the end, the handover to the manufacturing. So, bringing seamless without gaps,

00:11:28 without informational issues between R and D and manufacturing, bringing the information over in a validated manner into production.

00:11:41 Clearly, production may need to adapt, but this can be then reflected back into R and D, if they can rely on the information coming from R and D.

00:11:52 Let me talk a little bit about the next weeks. So, week two focuses on the idea and concept phase.

00:12:04 So here it's about managing the ideas, managing innovations, identifying trends, making decisions for the portfolio,

00:12:15 and agreeing and setting up the projects for the development. And then, based on that,

00:12:25 generating the task, the timelines, tracking the project, and doing also the different profitability checks

00:12:40 with the project management. And at the same point in time, also getting transparency.

00:12:46 Where is my project? Do I have critical resources that may be needed from multiple projects in parallel?

00:12:56 How do we solve that? So, if you can do that in the early phase, then it's much simpler to match and shift

00:13:04 and move the timelines or task sequences between different projects so that these critical resources are available when you need them.

00:13:14 So this is what you will hear in week two. In week two, then we do the collaborative product development.

00:13:23 So that means now the recipe developer is working on the product. He uses the raw materials, put them together in recipes,

9

00:13:35 and figures out the results for the finished product, maybe in a calculated manner, maybe really physically

00:13:46 as a product trial, which then gets measured and checked against the target. Also about how to manage the physical,

00:13:57 chemical, and declarative information around this product, around the raw materials, and the information that goes on the on the package.

00:14:06 And also creating, within the recipes, the product, the formula, getting the complete overview about

00:14:20 the input items, the product properties, which components go inside, if I have different raw materials, how much of a certain vitamin or component

00:14:34 they bring with them, and in which steps they are consumed and worked on. And at the end, to see how all these input items and raw materials contribute

00:14:50 or build up the finished product so that the nutritional values and compositions and so on are generated, documented, and managed in the recipe.

00:15:06 And in week four, then we talk about finalizing the product on the handover.

00:15:14 So, one thing is to ensure the compliance. As I stated before, it's not only the compliance part,

00:15:23 if this product is sellable in this manner to the targeted marketing. Also, can it be shipped?

00:15:32 Maybe safety data sheets, rules for different countries. Also handling and generating labelling in declaration information for the products.

00:15:44 Product data sheets, what you will share with your customer, for example. And also how to manage the release process

00:15:54 and the different steps during the manufacturing and the approval for the handover into manufacture

00:16:02 and how this gets synchronized into between R and D and manufacturing. So with that overview, I'm nearly at the end of this unit.

00:16:16 So I think what are the business values, what you will see in the next weeks? One thing is you will see how

00:16:28 the innovation can be executed faster and how new products can be developed faster. Or you can institute design excellence,

00:16:43 so setting up process, reusing existing information, reusing existing knowledge. And the compliant product lifecycle management,

00:16:55 so that means checking, during the development phase, during even the complete product lifecycle,

00:17:03 that the product is and stays compliant to the different regulations and rules and targets that are given for it.

00:17:13 And at the end, under the line, is to increase the profitability and the visibility of the process

00:17:23 where the process and the R and D cycle is at this certain point in time, and to see that. So with that,

00:17:35 it's possible to reach 25 percent faster time to market for new products by managing

00:17:43 the projects, the documentation, the project launch, and all the different steps.

00:17:50 And with that, it's also possible to reach 11 percent more launches of new products,

00:18:03 having them compliant and suitable for the desired markets and for the desired purposes.

00:18:15 So, with that, we are finally through. So, I think just to summarize here the key learnings.

00:18:24 I think the first part is, with SAP PLM,

00:18:31 you can manage your R and D project, starting from the idea, via the development, managing the portfolio, managing the project.

00:18:46 Second topic with SAP Recipe Development, including the specifications of the raw materials and the products, you can manage a complete

10

00:18:57 product generation process as well as the properties information and all the relevant product, raw material, and declaration information.

00:19:11 And third, with the compliance integration during the development cycle as well, at the end,

00:19:20 you can continuously do compliance checks to be on the safe side, that the product at the end of your R and D process fits the targets and the regulations

00:19:33 and then hand that seamlessly over into the manufacturing, for example, by handing over the bill of material to adapt it already to a certain production line.

00:19:46 With that, I finished up unit two. Maybe giving you a short outlook to unit three, so unit three, working with

00:19:55 PLM in prosses industries, here you will get an introduction to the typical processes in the process industries, how all this information is managed

00:20:08 and what information is involved in this process of developing the process and what are the needs there.

00:20:17 So with that, I thank you very much for your attention and wish you a nice time with the following units.

00:20:28 Thank you.

11

Week 1 Unit 3

00:00:04 Welcome to unit three of the openSAP course SAP PLM for process manufacturing. My

name is Juergen Scholl,

00:00:10 I'm the responsible product owner for PLM for Process Industries and the chief product owner for PLM Recipe Development.

00:00:18 I will guide you through this unit, Working with PLM in Process Industries. In unit two, you have heard about a major

00:00:26 solution capabilities of the PLM solution, and how in the units within the next four weeks of this course, these

00:00:37 capabilities are reflected and you get information about it. In this unit, I will give you an overview of the R and D processes

00:00:47 the involved roles and tasks, the relevant information and data, typical processes, but also deviations from that, and the derived information.

00:00:57 With that, you have then the base for the following units. Let's look at the processes and the roles.

00:01:07 If you look at the end-to-end process of the R and D, you have at the beginning ideas, requests.

00:01:16 You decide to generate a new product out of that, to develop it as a product. You need to set up projects.

00:01:26 Then you have a concept and trial phase, where you figure out how this product can be built,

00:01:33 then you formulate the product and the recipes, you have to do compliance checks against your targets

00:01:40 for the product, and you have to generate declaration information, and at the end also generate the necessary object for the manufacturing in the handover process.

00:01:51 To manage this overall process, the project manager is an important person.

00:01:57 He sets up the project, looks for the resources, checks if they are resource conflicts and finds the experts,

00:02:08 and he's also tracking the project and its progress overall. In the early phase here, we have product managers and marketing,

00:02:19 who are looking at trends, who are looking at ideas, generating change requests for new products, and describing, in the product brief

00:02:28 handed over to manufacturing, what the new product should look like. The recipe developer then

00:02:37 develops trial recipes, he makes different trials, documents them also for IP purposes.

00:02:44 He may get in contact with a supplier to gather information about new raw materials he may need to develop this product.

00:02:53 And he interacts with the laboratory assistant because he needs for his samples, for his drugs,

00:02:59 he needs measures to validate that the recipes has developed, the product he has done fits to the targets of the intended product.

00:03:12 Based on the trials, then, if the right one is found, then the development of the general recipe starts.

00:03:20 So this is the recipe that is then worldwide within the company valid. And derived out of that, site recipes

00:03:29 with site-specific information need to be developed. These recipes consume, on the one side,

00:03:38 specifications describing the raw materials. So it's not the material master that is used, specifications are used.

00:03:47 And the recipe output then is transferred to the product specification, which will later on describe the properties of this product.

12

00:03:59 But also packaging is involved, so they may need to talk to their

00:04:04 suppliers about the package, the package design, the artwork. And if you look at two words, declaration information, then if you look for food industry,

00:04:16 then we have the label expert, who generates, out of the recipe information, the composition, the product information

00:04:27 he generates the product label declaration, including the nutrients facts panel, allergens listings, things like that.

00:04:38 But there's also the compliance engineer involved because he needs to check if this product can be sold to the targeted countries, based maybe on the

00:04:48 compositions inside of this product coming from the ingredients. Or he needs to create certificates

00:04:56 or product safety data sheets to be shared with the customers. And if this is a product that needs to be registered officially,

00:05:09 then also a compliance engineer works with the legal authorities to bring together this information and

00:05:17 hand that over to the legal authorities to get the approvals. If we go then forward into manufacturing, specifically for new products,

00:05:28 we need material and master data because these are the central objects to drive the logistical information.

00:05:35 So the master data responsible takes care of that. The process engineer

00:05:42 picks the R and D recipes, which include, very often, already a process definition, but only to this extent as it is needed for the R and D development.

00:05:55 Detailed specifics for a single production line and things like that, this is then the task of the process engineer

00:06:02 to transform this recipe from the PLM recipe into the BOM or into a master recipe. And also the purchaser is involved because, based on the raw material,

00:06:15 what the recipe developer figured out and found out, this is the right raw material that I need, I have talked to the supplier, this is the information.

00:06:24 Then purchasing specifications get created because the purchase also wants to look to other suppliers, if they can deliver this product.

00:06:35 Now, looking at what other data objects are used in the PLM solution. The product manager deals with

00:06:47 documents describing trends, describing product ideas, and things like that. He deals with ideas.

00:06:56 When they trigger changes, they deal with change requests or structured requirements, not only based on documents.

00:07:07 The recipe developer develops, within his part, different types of recipes, trial recipes, and so on.

00:07:16 So he deals with recipes and with specifications. As well, the packaging department, more or less working with the same object.

00:07:28 The label expert for the food industry deals with label sets, as I stated before, which contain

00:07:36 the necessary declaration information for the package or for the Web pages on the Internet. The compliance engineer works as well with documents and he gets information

00:07:48 from the recipes, from the specifications, to generate this necessary information. And he then collects, based on this

00:07:57 information, summarizes this information to the necessary documentation needed for the legal authority.

00:08:08 If the product should go into production and it's a new product, then also the master data needs to be created.

00:08:17 In that case, the material master for the finished product done by the master data responsible

13

00:08:24 and the process engineer generates BOMs and master recipes. And as stated before, the purchase of deeds as well with the specifications.

00:08:32 What we see here in the R and D process for PLM for process industries is that the most central objects are

00:08:38 the specifications describing all the detailed properties of a raw material and finished product, and the recipes describing how these

00:08:49 ingredients and so on get put together and get processed to define the product. And so these are the two major objects, as we see here on the page.

00:09:04 Let's now have a little bit of a dedicated view of the business information flow and the objects that are involved in this process.

00:09:14 So, looking at the product. At the end of the trial phase, when a new product

00:09:21 is defined and identified, then a product specification is generated. And this will need to be flexible because the recipe developer may

00:09:32 have set up multiple variants of it to figure out which one is the best one. And then if this gets handed over into

00:09:41 manufacturing as they did before, then the material master is necessary. But based on the material, on the pack size, on the

00:09:51 customer and so on, there might be different material numbers. So the material master is the logistical object to be handled in sales and manufacturing,

00:10:02 and this relates to the product specification. And this is the reason why we see here a 1:n relation.

00:10:11 Similar for raw materials specifications, also here, it needs to be flexible for the recipe developer to create them based on

00:10:19 samples he gets, based on information he gets from his supplier. And he develops this information finally

00:10:27 to all details that are necessary for purchasing. And then the same spec could be used or purchasing specification could be

00:10:35 created out of that, describing this raw material with all its properties. But similar here to the product,

00:10:42 also you have a material master, but you have different material numbers for that because you have, as I stated

00:10:52 before as well, different pack sizes or different suppliers. So also here we find this 1:n

00:10:58 relation between the specification and the material master. Very important as well is here that in most companies, the creation of a material master

00:11:10 as well as the BOM and so on are very governanced processes. So that material masters don't get generated without any purpose later on.

00:11:27 Looking at the recipe floor, so as stated before, the recipe developer does a number of trials to figure out which

00:11:38 combination of the raw materials fits best to the product. And over time, one or two of these recipes might be then the winning recipe

00:11:49 in the sense, okay, this leads forward to a product. So based on that, then he will define the general recipes

00:11:57 for the overall company. And as a next step, deriving from that,

00:12:03 he then adapts these things to the single side. So here we see, as well, a 1:n relationship between general and site recipes.

00:12:14 With the site recipes, we have then all R and D relevant information defined, the input items, the processes, and so on.

00:12:24 But there are still things that can deviate on the manufacturing side but are not

00:12:31 important on the on the product definition side. So, for example, in the production, you

00:12:37 need an additional paper layer or something like that so you may enhance the bill of material

00:12:43 on the manufacturing side with that information. But this does not impact your product.

14

00:12:48 So that means here we also see a 1:n relationship between the recipes on the R and D side and then the final

00:12:58 executable recipes on the manufacturing side or the BOM on the manufacturing side. Looking at the derived information,

00:13:08 so out of recipes, specifications in the food industry, product labels get defined.

00:13:15 But here as well, according to the countries you are delivering this product to, you may need different declarations.

00:13:23 So you have a different nutrition facts panel and so on. So here we see a 1:n relationship.

00:13:30 This information, together with the recipes and so on, also defines the product factsheets and contains two product factsheets.

00:13:42 Also, certificates need to be generated. And labels, certificates, product information,

00:13:49 this is then, if necessary, summarized to the registration information where also multiple ones of them, 1:n,

00:13:58 get into this overall information shared afterwards with the legal authorities. But I also want to point out here one

00:14:09 important deviation to the process that I described above. In industries and companies where it's

00:14:19 necessary to fast develop new products, in that case, usually raw materials and according to the request of your customer, then very often a product

00:14:34 specification gets generated in the early R and D phase directly together with the material master.

00:14:42 And here, usually in a 1:1 relationship, without any extensive governance on the material master.

00:14:50 Because this material is just used to drive the logistical processes for this

00:14:58 raw material, for example, to send pre samples to your customers or generating additional information in the logistical process or store then.

00:15:11 And such industries are, for example, flavor producing companies or companies producing special chemicals.

00:15:22 With that overview, we are through the unit and I just want to summarize here three topics of key learnings.

00:15:33 One thing we saw on the process in the object is that the central two objects in the PLM for process industry solution

00:15:45 are the specifications and the recipes on the PLM side. There are others as well,

00:15:51 but these are the most important. What we saw is, during the development process,

00:15:58 the raw materials are not always all in place, they need to be developed in parallel and often in collaboration with the suppliers.

00:16:10 And to generate material master to drive afterwards the logistic process, this is, as I stated in the most companies, a very governanced process.

00:16:27 And therefore, this takes time. But there are also companies where this process is not valid.

00:16:38 As I stated before, flavor, especially chemicals, to be able to shortly react on requests of the customers to quickly generate them.

00:16:56 With that, I am at the end of this course. In the next unit, PLM Customer Stories in the Consumer Product Industry, you will

00:17:07 see how our customers use the PLM solution in their companies. And with that, I want to thank you for your attention.

15

Week 1 Unit 4

00:00:04 Hello, folks, welcome back to the openSAP course. My name is Manoj Kaippilly and I'm

00:00:10 the solution owner for PLM for process industries. In the previous units, you were introduced to PLM and different

00:00:18 stages of the process of ideation to consume. You also saw the related data model and a typical business object flow in PLM.

00:00:28 We will now take a look at PLM customer experience and how it is relevant to consumer product industry.

00:00:36 Let us start by defining industry consumers. Unlike olden days, today's consumers can make or break a business

00:00:45 and they are all well connected. Whether a product is good or bad,

00:00:50 opinions and feedback spread like wildfire. Today's consumers know very well that the presence in social media

00:00:58 and the views aired in these platforms are being closely monitored by companies. These are not the type of people who use

00:01:05 social media for just sharing personal photos or chatting with friends. These are educated,

00:01:12 knowledgeable individuals who do not shy away from sharing what they have in mind. Even though this is a challenge for corporate strategies, with a proper

00:01:21 approach and by bringing innovation in product offerings, they can actually turn this giant marketing machinery to the company's advantage.

00:01:30 A connected and informed consumer will be demanding. But at a time when even toddlers tend to read product labels to see if they are

00:01:39 organic or not, or the package is using recycled materials, it is only logical that customers are demanding.

00:01:47 This is creating a customer base who are engaged, who want to be involved in the development and definition of the products they buy.

00:01:55 They want to be collaborators, not just consumers. And unlike olden days, they are also responsible.

00:02:03 A majority of the customers are sustainability conscious. They are more health conscious,

00:02:08 and they do understand the responsibility of keeping our planet clean and sustainable for the future generations to enjoy.

00:02:16 In a nutshell, for a company that invests in innovative ideas, procures tools to nurture and enrich those

00:02:24 ideas to develop their products, these consumers are a goldmine. So, let us see what inspires the digital transformation of product development.

00:02:35 The consumers we talked about and the challenges faced by the companies warrants an integrated digital product development environment.

00:02:45 This will enable them to react quickly to fast changing consumer demands. They need access to tools which are customer centric, robust, and flexible.

00:02:56 R and D need to know what transpired and the reason for innovation by knowing the upstream processes,

00:03:04 they also need downstream process visibility to know and make sure that the product they envisioned in their lab is what actually is being produced

00:03:14 in the manufacturing plant. For raw materials, they would like to collaborate with suppliers more closely so they can

00:03:21 get the exact raw material as part of the specification. They want to collaborate with their core

00:03:26 manufacturers to make the formulations they zeroed in on after several experimentations. They may even want to collaborate

16

00:03:34 internally with plans to give them a heads up on what is coming their way. Access to product compliance and automated calculations provided will make sure

00:03:45 the demand for compliance and sustainability is met. They also realized that the lack of these

00:03:52 tools can result in overuse of corporate resources. And as always, the pressure to reduce

00:03:58 the cost and deliver the products to market faster will always be there. Now, let us look at SAP's holistic approach to support product development.

00:04:09 First and foremost, to support all the regulatory requirements, you need data accuracy and reliability.

00:04:17 This can be achieved by having only a single point of truth with digitized product development solutions to support end- to-end processes and much more.

00:04:28 Now, let us look at where our solutions, SAP solutions, map into a typical stage gate process.

00:04:36 This is a typical funnel. Stage names may differ based on consumers, but most will follow a standard process.

00:04:43 It starts with discovery, where companies collect ideas or requirements. Then, after proper evaluation and enrichment, a project will be created.

00:04:52 Project evaluation is followed by approval process, which will be the start of the development stage.

00:04:58 R and D will start with experimenting different recipes, and if new raw materials are warranted, they collaborate with suppliers to develop this raw material to perfection.

00:05:10 Product compliance and labeling tools will be used in every step of the development cycle.

00:05:16 Once R and D is confident of the formula, it will be handed over to manufacture. As you can see, the slide shows how our

00:05:24 solutions effectively help in every stage of this end-to-end process. Apart from the solutions shown, tools like Product Lifecycle Costing,

00:05:32 Qualtrics are also available at their disposal in all stages. Now, let us see how companies make optimal use of these tools.

00:05:43 They now are capable of manufacturing highly individualized products. There is more transparency and is only a single source of information.

00:05:53 Intellectual property will be protected and can be reused. They can also rely on stricter change control

00:05:59 with more streamlined project and process management. So, now what are the key learnings?

00:06:09 PLM is becoming a necessity rather than something nice to have for process industry, especially in the consumer product industry sector.

00:06:17 An integrated end-to-end system definitely helps consumers to take these challenges head on and take advantage of the demand.

00:06:26 R and D now will have visibility to both upstream and downstream processes. This enables them to collaborate better

00:06:33 with colleagues, suppliers, and ultimately the consumers. Last but not least,

00:06:39 this is the opportunity of a lifetime to turn social media into a proponent of the products other customers make by utilizing all these tools.

00:06:49 Help this unit give you an overall view of how customers can benefit from PLM. Please do answer the questions part of this unit to test

00:06:58 what do you have learned in session. Thank you for stopping by and attending this openSAP course.

17

Week 1 Unit 5

00:00:04 Hello, welcome to the openSAP course on PLM for Process Industries. My name is Sethu

Sethurama, I'm a business development manager in North America.

00:00:14 My team supports with services in sustainability solutions, enterprise asset management, and PLM for process.

00:00:24 In unit five of week one, we will discuss PLM in chemical industry. In the previous unit you might have learned about

00:00:33 how SAP PLM is utilized in consumer product industry. Before we start looking at how PLM is used in the chemical industry, let us discuss

00:00:44 what are the complexities of research and development in the chemical industry? What are the success strategies of product development in the digital economy?

00:00:55 How chemical industries are looking at optimizing chemical usage and applications? What is SAP's holistic support for the product development process?

00:01:09 We will also look at how SAP's products are integrated. Finally, we will discuss how

00:01:16 chemical industry customers and consumer product customers use SAP PLM. The goal of R and D personnel in the chemical industry is to reduce the development cycle

00:01:29 with faster time to market at lower cost, at the same time, fulfilling their ever-changing regulatory and customer-driven requirements.

00:01:41 These goals need to be achieved by considering business risks and market demands.

00:01:48 They also need to consider sustainability while globalizing the supply chain. In order to achieve these goals, they require new technologies

00:01:58 and digitalization of the labs, with the need to maintain accelerated growth of available scientific information.

00:02:08 Based on the requirements of research and development in chemical industry, what are the strategies that can help

00:02:16 to succeed by taking advantage of the digital economy? We saw that they have to achieve speed so they can automate processes by removing

00:02:26 inefficient steps and utilizing resources for valuable activities. They need to analyze the data.

00:02:34 They can utilize HANA to get real-time data to analyze and make right decisions. We saw compliance, which is a major requirement for the chemical industry.

00:02:45 They can achieve this by embedding compliance in the product lifecycle to make sure that products meet the regulatory and other requirements.

00:02:56 In this age of the digital economy, enabling collaboration between internal and external parties is very important.

00:03:05 Customer requirements will vary. It requires offering more regionalized products with a batch size of one,

00:03:13 and allows users to personalize the tool to meet the business need, to make it ease of use with Fiori.

00:03:22 The main focus of research and development is to optimize chemical usage and performance. They like to reduce the lab trials through simulation and decision support

00:03:34 to meet customer requirements with existing R and D data to generate optimal proposals quickly, without reinventing the wheel,

00:03:43 by utilizing Big Data and predictive analytics, and thus achieving shorter time to market. To identify how chemicals are performing,

00:03:55 customers utilize Internet of Things and machine learning applications for integrating with sensor data.

00:04:04 Customers look for innovation in business networks using Blockchain. Improves the product development, differentiates with other customers,

00:04:15 generates revenue from new services, and lowers dependency on product volume. Now, let us look at how SAP can help

18

00:04:24 support research and development in chemical industries. SAP Cloud Platform can support collaboration between projects

00:04:35 and with communities using collaboration tools like intelligent product design. To search and share documents and information,

00:04:45 to make available product information in a customer portal. Research and development can be supported by SAP S/4HANA.

00:04:56 Starting from managing projects using project and portfolio management solution, to create and optimize formulations, develop process instructions,

00:05:09 and hand over to manufacturing using recipe development. To conduct multiple trials and to maintain test results using quality management.

00:05:20 To incorporate regulatory checks, generate labeling safety data sheets, using product compliance.

00:05:29 To manage master data, master data governance solution of SAP can be utilized. HANA and the SAP Cloud Platform can help

00:05:38 with the requirements to extract data from patterns, articles, and social media. Experimental design using predictive analytics on Big Data,

00:05:50 data integration for consolidating both structured and unstructured data, including images. To provide user-friendly interfaces using Fiori

00:06:01 and to support all devices, including mobile and smart glasses. Customers look for an integrated solution to avoid maintaining multiple interfaces

00:06:14 and the requirement to translate data between multiple systems. SAP solutions provide strong

00:06:22 integration between different functionalities in the same environment. Starting with the creation of ideas using

00:06:31 SAP Innovation Management and the ability to directly transform the selected idea to project and portfolio management for managing as a project.

00:06:43 Project tasks provide links to create ingredients in specification management and recipes in recipe development.

00:06:53 Document Management solution provides the ability to manage documents throughout the whole solution.

00:06:59 Example, specification documents, compliance documents, and so on. Specification management and quality management are integrated with the ability

00:07:11 to directly create inspection characteristics in quality management, using data maintained in specification management.

00:07:21 Compliance can be checked during formula development using compositions generator in Recipe Development as an outcome of formula maintenance.

00:07:33 Formulations can be directly interfaced to create bill of material and master SAP in manufacturing,

00:07:40 using handover to manufacturing capability within SAP PLM. Compliance checks can be extended during procurement using information from product

00:07:52 compliance, such as registration information. Now, let us look at your customer,

00:08:01 how they chose SAP PLM. It is a chemical company in the US with about 7,000 employees, they were looking at your

00:08:10 solution to maintain formulations that were maintained in the home-grown system. The capabilities they were looking at in the system were

00:08:20 to manage formulations along with integration to their SAP EH and S regulatory for compliance and manufacturing with bill of materials.

00:08:30 The customer chose SAP Recipe Development solution because of having a common user interface for both formulators and regulatory professionals

00:08:41 and the ability to integrate with quality and manufacturing process. The customer benefited from improved

00:08:49 collaboration, reuse of data, and search performance. This enabled them better data accuracy and better decision making with analytics,

19

00:09:00 and streamlined the business process. Now, let's look at another example, the consumer product customer in the US.

00:09:10 They wanted to move away from an independent formulation system to avoid the requirement to constantly

00:09:17 move data between formulation maintained in legacy system and regulatory manufacturing done in an SAP system.

00:09:28 The customer took advantage of SAP Recipe Development solution, which integrates with SAP EH and S for regulatory and the ability to directly create bill of material

00:09:39 from formulation maintained in Recipe Development. The customer benefited from having one source of truth to maintain formulation,

00:09:50 check compliance, and synchronize the formulations with the bill of material. The customer was also able to get the benefit of incorporating compliance check

00:10:01 at the time of formulation creation itself. They were able to utilize the compositions

00:10:07 created in Recipe Development to do further regulatory checks. Create safety data sheets by transferring the composition to product compliance.

00:10:19 The customer was also able to utilize the labeling functionalities within Recipe Development to directly transfer their ingredient, nutrient,

00:10:30 and allergen data from formulation to labelling. Thus, by avoiding data moment from multiple systems.

00:10:41 So, now let us summarize our learning. In the chemical industry, the fulfillment of a fast- growing number

00:10:49 of regulatory and customer-driven requirements are challenging. The industry is moving from delivering

00:10:57 chemicals to optimizing chemical usage and applications. Research and development is supported by

00:11:05 multiple capabilities, such as formula and process development, project management, compliance management, and master data management.

00:11:16 I hope you enjoyed the session. Thank you for your attention.

00:11:20 You will enjoy the rest of the course, as well. Thank you, bye bye.

20

Week 1 Unit 6

00:00:04 Hello, and welcome to today's openSAP course, where we explain why Product Lifecycle

Management is so important for

00:00:11 the Life Sciences industry and see how Life Science companies use SAP PLM. My name is Andrea Kaufmann and I am the

00:00:20 global marketing lead for health sciences at SAP. This openSAP unit is the last unit in week one of the openSAP course.

00:00:31 It's an overview session similar to the consumer products and chemicals industry course.

00:00:37 At the time this unit is recorded, we are in the recovery phase of the corona pandemic, everybody is eagerly awaiting a COVID-19 vaccine.

00:00:47 Developing a new drug normally is a long, complex, and very costly process. It can easily take 15 years before a new

00:00:55 drug is approved for selling in a certain market, in a certain country, and only a very few new compounds or

00:01:03 substances that are initially tested will ever make it to the market. This is the funnel of Life Sciences.

00:01:12 If a Life Science company is lucky, one drug out of 10,000 tested ever reaches the pharmacy and can be sold to patients.

00:01:21 And this one drug then needs to recover the cost of all the failed attempts as quickly as possible.

00:01:28 Due to the long drug development time, there might not be much of a patent life left.

00:01:33 Patents are usually granted for 20 years, but you have to register your patent early on in the lifecycle of a so-called API, an active pharmaceutical ingredient.

00:01:44 So, depending on how long it takes from drug discovery to market approval, the pharmaceutical company might only have five years of patent protection left.

00:01:54 After patent expires, generic companies are ready to manufacture and will sell the drug at a cheaper cost

00:02:01 without having to invest in the cumbersome and costly drug development process. The average cost to bring a new drug to market

00:02:11 is around 1.3 billion US dollars. It is important that Life Science companies need a solid revenue stream

00:02:18 or an investment-friendly environment to pre- finance the development and manage the risk of failed attempts, because the outcome is not guaranteed.

00:02:29 You might wonder what makes finding new drugs so costly and complicated. Not only do you need modern laboratories to identify and analyze potential compounds,

00:02:40 but the Life Science company also needs to prove the success of the new active pharmaceutical ingredient and ensure that the resulting drug is safe for patients.

00:02:52 Initially, the drugs are tested on animals, then different dosages are tested on humans.

00:02:58 First, only a few volunteers test the drug in a phase one clinical trial to ensure nobody dies or is harmed when taking the drug.

00:03:07 Phase two of the clinical trial then enrolls more patients to test that the drug actually helps against the disease.

00:03:14 Sometimes you find out that the drug is no better than a placebo or an already existing drug, then it is often not worthwhile to proceed.

00:03:23 Or you find out that it does not work for the intended disease but has a positive effect in a completely different therapeutic area.

00:03:32 Some might remember that this is what happened with Viagra. In phase three, the drug is then tested on more patients

00:03:40 to identify additional patient side effects, which might only happen rarely and therefore can only be observed in larger patient populations.

21

00:03:52 If, after all the tests, a statistical evaluation shows evidence that the new drug is safe and better than a comparator drug,

00:04:00 or at least as efficient as a comparator drug, but with fewer side effects, the next step is for the Life Science company to request market approval for the new drug.

00:04:11 Each regulatory agency in every country where the drug is intended to be sold will read the results from the animal and clinical tests and then approve

00:04:19 or reject the approval that the drug can be sold in their country. Sometimes, regulatory agencies ask for

00:04:26 an additional phase four test, so-called post marketing studies. During this phase, the drug composition,

00:04:32 the medical results, and approval status per country needs to be captured. In addition, every potential change that

00:04:39 can happen in the course of the drug lifecycle needs to be tracked and potentially submitted to the regulatory agencies for reapproval.

00:04:49 This change can include a label change, a change of the supplier, a change in the manufacturing site,

00:04:56 the manufacturing process, the cleansing of the machines, the environmental parameters, the type of water used,

00:05:04 the level of impurities in the ingredients, the quality procedures applied, the shelf life, updated medical information like adverse

00:05:13 events that might have occurred, or new patient group like children or elderly, for which the drug might also be used, and there's many more.

00:05:22 Each of these changes need to be reported to the regulatory agencies around the globe, but not all might approve each change.

00:05:30 This can lead to a lot of product variations. Over time, the Life Science company needs to ensure that only the approved

00:05:37 variations get shipped and sold in that country. The success of a Life Science company and their revenue stream is directly related

00:05:45 to how many new drugs they can get to market in the shortest time possible and to efficiently manage changes and variations over time.

00:05:56 In the past, Life Science companies managed submissions of a drug or device information and the multiple changes as documents in dossiers.

00:06:05 The regulatory agencies are now requiring structured product data so that they have a better overview of the medicinal products, ingredients,

00:06:15 suppliers, and clinical particulars like therapeutic indication and side effects. For example, in case of an adverse event, Life Science companies can run reports

00:06:26 instead of having to analyze long text documents in the submission dossiers. This approves not only the efficiency of the process, but also provides better

00:06:36 transparency and afterwards improves patient's health by being able to inform them about adverse events or issues at a supplier faster than in the past.

00:06:48 In order to fulfill the regulatory requirement for structured product data, Life Science companies now start looking at

00:06:54 PLM to digitize drug substance and recipe data. Compliance requirements are certainly the

00:07:03 most forceful driver in the Life Science industry, where non-compliance could put the whole company out of business.

00:07:10 It is mandatory to provide the regulatory mandated information to the various regulatory agencies,

00:07:16 and it views the regulatory approval information into the overall medicinal product development and supply chain processes.

00:07:28 This helps to ensure jurisdictional control so that only the right and approved product variations get sold in the respective countries.

22

00:07:38 But there is more than compliance to be successful. Life Science companies need more medical data in a structured format to prove that

00:07:47 the drug works well in the real world and warrants its price. And since the diseases are very complex,

00:07:56 for example, in oncology, which require individualized treatments based on a patient's genetics, much more data needs to be assembled

00:08:05 by the various stakeholders in the Life Sciences and health care industry. These stakeholders need to collaborate more tightly than in the past to achieve

00:08:16 better medical insights and faster medicinal product development. This is only possible when you have

00:08:25 structured, standardized, and digitized data that can be shared and understood by all. Digitized data and tighter collaboration

00:08:37 are required to support the end-to-end lifecycle process of a medicinal product. SAP supports Life Science companies from early idea and portfolio decisions

00:08:48 through the specification and formulation process. SAP helps collaborate with suppliers and development partners and helps them manage

00:08:58 the document and changes as well as a data collection to apply for market approval. SAP PLM connects the diverse steps and departments

00:09:09 and helps manage product changes over time. It also helps make portfolio and costing decisions, executes projects and clinical trials,

00:09:21 manages substances and recipes during the development process. The solution checks compliance, requests regulatory approval,

00:09:31 then hands the recipe to the manufacturing team by creating material master data, bill of materials, and site-specific recipes.

00:09:40 SAP PLM efficiently manages all of the connection points, the roll up of product and resource costs, and the seamless passing of information.

00:09:50 Data only needs to be entered once, but can be reused by subsequent teams and processes.

00:09:57 This reduces errors, provides trusted data and transparency, of product and process information for better decision making.

00:10:07 SAP delivers holistic support for this Life Science development process, from research to the launch of a medicinal product to the market.

00:10:17 Various solution components play a role during different stages of the drug development process,

00:10:24 like innovation management that usually supports the ideation process, or the product compliance and submission management solutions

00:10:34 that ensure regulatory compliance. Other components, like document or project management,

00:10:40 are used in every phase throughout the development process. Now that we understand the drug development process,

00:10:51 let's have a look at what SAP customers do with SAP PLM. This is an example from a European vaccine's manufacturer.

00:11:01 They use PLM as their backbone to prepare for the upcoming IDMP regulations. They started with implementing the specification database

00:11:12 and then subsequently the SAP Recipe Development solution. Their complete product master data management

00:11:19 was moved from Excel into a software system, which made product data more transparent, easily available, and served as a single source of truth

00:11:28 with higher trust in the correctness of the data. With SAP PLM, the European vaccine manufacturer

00:11:36 accomplished standardization of product data that led to better interoperability and end and connectivity.

23

00:11:43 They can now support the full product information lifecycle to ensure completeness and compliance.

00:11:49 They improve collaboration with other departments, like R and D and Regulatory Affairs.

00:11:56 And with PLM, they are better equipped to manage diverse regulations like IDMP, Falsified Medicines Directive, future e-Labeling and e-Prescription demands.

00:12:10 As a second customer example, let's see how an American medical device

00:12:14 company transformed their processes with SAP. The goal was to digitalize

00:12:20 the entire design and manufacturing process, to reduce time to market and cost, and use various SAP solutions from the PLM area, like environmental health and safety,

00:12:32 product management, or product lifecycle costing. On average, what they received with SAP was that product design changes can now be

00:12:41 completed in days or weeks, which previously took months. And just by eliminating paper,

00:12:48 this paid off the investment for the software implementation. With SAP, the American medical device company

00:12:56 improved time to market and saved cost. They increased efficiency and profitability.

00:13:04 They implemented an end-to-end digitalized product development process. In summary, why is SAP PLM important for our Life Science customers?

00:13:17 Life Science companies struggle with a lengthy, expensive, and complex development process to bring medicinal products to market,

00:13:25 and they need better system support to improve time to market. Regulatory agencies will require more digital product data in the future.

00:13:34 Therefore, Life Science companies need to be prepared for the digital world and start implementing the SAP PLM.

00:13:42 Front runners who have implemented SAP PLM see value not only in regard to compliance, but benefit from process

00:13:49 efficiency gains and transparency into product details. Now enjoy the rest of the openSAP course,

00:13:56 and thank you for your interest in the Life Science process.

www.sap.com/contactsap

© 2020 SAP SE or an SAP affiliate company. All rights reserved. No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP SE or an SAP affiliate company. The information contained herein may be changed without prior notice. Some software products marketed by SAP SE and its distr ibutors contain proprietary software components of other software vendors. National product specifications may vary. These materials are provided by SAP SE or an SAP affiliate company for informational purposes only, without representation or warranty of any kind, and SAP or its affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP or SAP affiliate company products and serv ices are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty. In particular SAP SE or its affiliated companies have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation, and SAP SE’s or its affiliated companies’ strategy and possible future developments, products, and/or platform directions and functionality are all subject to change and may be changed by SAP SE or its affiliated companies at any time for any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, and they should not be relied upon in making purchasing decisions. SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP SE (or an SAP affiliate company) in Germany and other countries. All other product and service names mentioned are the trademarks of their respective companies. See www.sap.com/copyright for additional trademark information and notices.