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?
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,

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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.

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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,

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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.

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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

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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.

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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,

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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

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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.

10
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.

11
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

12
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.

13
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.

14
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

15
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.

16
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

17
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,

18
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.

19
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.

20
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.

21
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.

22
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.

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