SAP S/4HANA IMPLEMENTATION

Put your trust in "VITAL"
the validated and innovative SAP S/4HANA implementation approach for Life Sciences

SAP S/4HANA IMPLEMENTATION IN THE LIFE SCIENCES


SAP S/4HANA is the 4th SAP ERP generation and supports companies in taking a big step towards digitalisation or smart enterprise. It covers all functions of ECC 6.0. In addition, some functions that were previously only available in SAP industry solutions or via the connection of third-party systems have been integrated into the standard.

In the course of SAP’s simplification and digitisation initiatives, S/4HANA received a completely new architecture and role-based user interface (SAP Fiori) as well as an intelligent data model. In combination with the in-memory technology of the SAP HANA database, business processes can be executed much faster and more efficiently and intelligent real-time analyses can be performed.
SAP S/4HANA can be operated both on-premise and in the cloud.


The implementation of S/4HANA must be thoroughly prepared. After all, it is about introducing or converting an integrated, business-critical business process system. The conversion to S/4HANA is a highly complex project with a large number of affected users and usually tight time and budget constraints. In addition, it usually runs parallel to ongoing operations, i.e. it must not interfere with day-to-day business and should require only a few downtimes, set-up times and conversion times.

For more than 25 years, DHC has been your competent consulting partner for all SAP topics in the life sciences. Our consultants not only have the necessary SAP knowledge, but also in-depth process and industry know-how in the regulated environment. On the topic of SAP ERP, we support you from the strategy, through the creation of the roadmap, to the implementation and validation according to our process model for SAP S/4HANA, as well as beyond that with support and services.


SAP S/4HANA OPERATING MODELS

With SAP S/4HANA, different operating models are also offered for the first time, because in addition to the classic on premise solution S/4HANA Enterprise Management, there are now also SAP S/4HANA Cloud solutions.

SAP divides the possible operating models for SAP S/4HANA into:

  1. As a Service (Cloud ERP, SaaS)
  2. As a Product (ERP AnyPremise, on any infrastructure)


SAP S/4HANA Cloud (formerly: SAP S/4HANA Public Cloud, Multi Tenant Edition, Essential Edition)

SAP S/4HANA Cloud is a true SaaS solution with highly standardised cloud services. It is a multi-client landscape, i.e. various SAP customers share a public cloud infrastructure. This operating model is therefore – in our opinion – not an option for the life sciences sector, but it should nevertheless be described briefly.

In this operating model, only the classic ERP core functionalities and selected Line of Business (LOB) processes are made available. Currently, no industry solution is offered for the life sciences.
Automatic release updates are carried out twice a year.

The path to the SAP S/4HANA Cloud is only possible via a complete new implementation (greenfield).

A periodic subscription fee (rental fee) is charged for use and licensing. With the exception of the implementation costs, all costs are covered, i.e. infrastructure costs, licences, maintenance fees, backups, operating costs, etc.


SAP S/4HANA Cloud, private edition (formerly: SAP S/4HANA Private Cloud, Single Tenant Edition, Extended Edition)

SAP S/4HANA Cloud, private edition

In contrast to SAP S/4HANA Cloud, SAP S/4HANA Cloud, private edition offers customers their own cloud infrastructure and includes the classic S/4HANA ERP system with the full range of functions (identical to S/4HANA ERP AnyPremise) as well as all available industry solutions and country versions. This variant can be customised and extended (extensibility), i.e. changes to the source code are possible but not recommended by SAP.
SAP provides one upgrade per year, whereby the customer can decide for himself whether and when to install this new release.

The path to the SAP S/4HANA Cloud, private edition, can take the form of a complete new implementation (Greenfield), a migration (Brownfield) or a “Selectice Data Transition” (Bluefield).

The cloud is operated at hyperscalers such as Azure, AWS, Google, Alibaba or in SAP data centres.

A periodic subscription fee (rental fee) is charged for licensing. With the exception of the implementation costs, this also covers all costs, i.e. infrastructure costs, licences, maintenance fees, backups, operating costs at SAP or a hyperscaler, etc.


SAP S/4HANA on premise

Of course, the classic SAP S/4HANA on premise version is still available, but SAP recommends that its customers operate S/4HANA in the cloud. S/4HANA on premise is a standardised SAP ERP generation that can be customised and expanded. Operation takes place in the customer’s own data centre, with a hyperscaler or as outsourcing with a professional data centre operator.

The path to SAP S/4HANA AnyPremise can either be a complete new implementation (Greenfield), a system conversion (Brownfield) from a previous SAP ERP system (Brownfield) or a “Selective Data Transition” (Bluefield).

This solution includes all available industry solutions and country versions. In addition, SAP S/4HANA AnyPremise can be adapted, extended and changed practically at will. SAP provides one new release per year, whereby the customer decides whether and when to install a new release.

The licences are acquired via a one-off payment and are subject to an annual maintenance fee.

The switch to SAP S/4HANA


Depending on the operating model, the path to SAP S/4HANA can therefore take the form of a complete new implementation (greenfield), a transformation / system conversion from a previous SAP ERP system (brownfield) or a “selective data transition”.
Which type of migration is used depends on various criteria, such as the customer’s existing IT system landscape, the desired degree of standardisation or customisation of the system or the decision for an on-premises or cloud operating model. Each approach has advantages and disadvantages that should be carefully weighed against each other.
We support you on your way to SAP S/4HANA and work with you to develop the roadmap that best suits your company.

When choosing the operating model, our customers in the pharmaceutical industry as well as medical technology must also take into account that they not only implement and maintain the system used, but also have to validate it with the introduction and with each update. With on-premise use – i.e. in-house – S/4HANA Enterprise Management is validated “classically”. If you opt for the cloud variant, there are a few special features to consider when validating cloud computing systems, especially in the life sciences. Although the company hands over the responsibility for operating the system and places it in the hands of the cloud provider, the responsibility for quality always remains with the client.

The implementation of SAP S/4HANA (Greenfield)


Greenfield is the term used to describe the implementation of SAP S/4HANA “on a greenfield site”. All processes and systems are completely newly installed and set up. In addition to new customers, existing customers whose existing ERP systems are very heterogeneous and complex should also consider the greenfield approach in order to fully exploit the potential and innovations of S/4HANA.

The goal should be to work close to the SAP standard and with best practices. Existing in-house developments and connected third-party systems are analysed to see whether the functions are already mapped in S/4HANA and, if possible, replaced. Based on the technological innovations of SAP S/4HANA, a complete reengineering and a comprehensive simplification of processes takes place.

The operation of the existing system can simply continue in parallel until the go-live of the SAP S/4HANA system.

With the greenfield approach, a completely new system and process landscape can be set up for existing customers with a database that has been cleansed of legacy issues. The orientation towards the SAP standard facilitates updates and functional extensions.

Disadvantages compared to brownfield can be increased time and costs for preparation, analysis of the existing systems connected systems and database structures as well as the transformation of processes and training of users.

DHC as a partner for the implementation of SAP S/4HANA


For over 25 years, DHC has been your competent consulting partner for all SAP topics in the life sciences. Our consultants not only have the necessary SAP knowledge, but also in-depth process and industry know-how in the regulated environment. We support you from the strategy to the creation of the roadmap to the implementation and validation of SAP S/4HANA according to our process model and beyond that with support and services.

Currently, there is a high demand for experienced implementation consultants. According to a recent study by IT Online magazine, this shortage of experts is seen as the second biggest challenge in implementing SAP S/4HANA. Since we are also faced with the challenge of being able to offer you corresponding capacities, we work together with a network of consulting specialists for the life sciences.

Our partner network: The LIFE SCIENCES ALLIANCE

In order to be able to offer you pragmatic, cost-optimised and reliable services and IT solutions when switching to SAP S/4HANA, we and the All for One Group have bundled our SAP Life Sciences service portfolio. Since 2020, we have been offering pharmaceutical and medical technology companies industry-specific SAP solutions and, above all, a coordinated approach for the implementation, system conversion and validation of SAP S/4HANA systems with the Life Sciences Alliance.

Our project methodology for the implementation and validation of SAP S/4HANA

The Life Sciences Alliance (LSA) has developed the VITAL© procedure for the implementation and validation of SAP S/4HANA. VITAL stands for integrated implementation and validation in regulated industries such as the pharmaceutical industry and medical technology.


The implementation and validation of SAP S/4HANA are not separated from each other organisationally and methodologically in order to avoid extra work, inconsistencies and errors! In the following, our approach is described in its main features. A modern approach to the implementation and validation of SAP S/4HANA contains elements of agile project methods such as SCRUM. In a regulated environment, the validation of the IT system is required, which is carried out according to the industry standard GAMP®5. This standard suggests the use of the V-model.
For the implementation of optimal processes, the use of business process management approaches in combination with a preconfigured solution architecture, oriented towards the Intelligent Enterprise philosophy, has proven successful.

The method combines the various approaches into a harmonised, consistent and cost-optimised procedure that is specifically tailored to the requirements of the life sciences industry. The project approach and methodology of the SAP S/4 implementation have a significant influence on the successful course of the project and the associated costs and efforts.

The basic understanding of SAP implementation is always based on the approach: Standardisation before individualisation! This is a must for the system introduction, especially with regard to ensuring release compatibility in the application and the outlook for the increasing digitalisation of business processes as well as openness to new business models.

Individualisation should only be used where the company’s USP depends on it and a unique selling proposition is absolutely necessary for business success.

 

VITAL’S SOLUTION COMPONENTS FOR THE IMPLEMENTATION OF SAP S/4HANA

Appropriate solution components are available in VITAL to accelerate the implementation.


Digital Process Landscape (DPL)

The Digital Process Landscape (DPL) contains all processes of the digital core that are relevant in the value chain as well as industry-specific solutions from the SAP Ecosystem and has been continuously developed in an evolutionary manner over the last 25 years. Two goals are pursued in the process,

  • Use of the business content to create the user requirements/user story and the resulting functional specifications, and
  • Creation of a redundancy-free and harmonised structure for the GxP-compliant operation of SAP S/4HANA.

 


Preconfigured solution architecture

  • Strong reduction of implementation time due to our pre-configured solution.
  • Wide range of industry-specific processes and functions for medical technology and the pharmaceutical industry
  • Easy adaptation of the solution to your company and organisational structure, also through a predefined role and authorisation model
  • High project and operational stability through pre-tested and audited industry standards
  • By applying industry best and right practices, you improve the cross-process integration understanding in your company
  • Increased usability through new user experience (SAP Fiori)
  • Availability for different operating models (S/4HANA on Premise and RISE with SAP, Private Cloud Edition)


IT Compliance Framework

The IT Compliance Framework is designed to ensure the implementation, validation and GxP-compliant operation of SAP S/4HANA from day one. It contains best-practice validation processes, SOPs and templates that are optimally tailored to SAP projects with the aim of secure implementation and operation of the system. This is particularly important when planning, hosting, operating and supporting in the cloud or outsourcing to a service provider, e.g. Life Sciences Alliance. When using the IT Compliance Framework, the prompt re-validation of the SAP system in the event of changes is guaranteed (Managed Validation Services).

Processes and SOPs are consistent and logically coordinated and ensure efficient and cost-effective operation throughout the entire life cycle.

  • All mandatory activities and functions of the CSV are defined in the framework.
  • Oriented towards the GAMP®5 V-Model and GAMP®5 Operation GxP Systems.
  • Focus on systems to support business processes


Validation Documentation

Standard requirements for SAP S/4HANA and sample documentation are provided via the validation documentation.
[CHECK.]

Best practice requirements at:
Business process level
Detailed process level
End-to-end documentation example

[/CHECK]


Digital GxP-compliant Lifecycle Management

About digital GxP-compliant lifecycle management, the standard requirements for SAP S/4HANA and sample documentation are provided

To ensure efficient validation processes in the project – but above all in the operation of the SAP system – LSA provides a cloud-based validation platform via which validation documents and SOPs are digitally managed and controlled. In addition, the SAP Solution Manager is used for the provision of the pre-configured and documented solution on the one hand and for the control of the IT processes (incident and change management) in support on the other. This enables the digital implementation of the IT processes described in the IT Compliance Framework for the efficient operation of an SAP system in the life sciences.

  • Part 11-compliant electronic signatures
  • Status of validation documents in dashboards
  • Automation and digitalisation of validation processes easily implemented
  • SaaS solution – ready to use

Informationsmaterial anfordern!

Learn more about the DHC approach for SAP S/4HANA implementation!

WHY CHOOSE DHC?

Benefit from our experience and industry expertise as a specialist for SAP S/4HANA implementation!

  • Over 25 years of implementation and validation experience in the area of SAP ERP.
  • Proprietary method for the implementation and validation of SAP S/4HANA = VITAL
  • Support during the changeover with the SAP S/4HANA Roadmap
  • SAP Silver Partner
  • Excellent industry know-how in life sciences (especially pharmaceutical industry and medical technology)
  • High level of process expertise
  • Sound knowledge of regulations (GAMP 5, ISO 13485, …)
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe
Switzerland
Carsten Buri

CEO and Director Sales & Marketing, DHC Switzerland

phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri
Request information!

Learn more about or consultimg services for SAP Life Sciences!

CUSTOMERS

Webinars and events

14. November
DHC web session (in German)

Webinar series: Implementing IDMP with SAP (Part 1)

Presentation of the EMA’s IDMP initiative and the SAP cloud application Gramont Polaris for regulatory dossiers.

more
15. November
DHC web session (in German)

GxP-compliant digitisation of laboratories

Discover how digital transformation is increasing the level of automation and optimising your laboratory processes in a GxP-compliant way.

more
20. November
DSAG event

Focus Day “SAP Digital Manufacturing” – DSAG AK Life Sciences Processes

Look forward to exciting talks, a visit to the new S.Factory and stimulating discussions.

more
21. November
DHC web session (in German)

Webinar series: Implementing IDMP with SAP (Part 2)

Presentation of Gramont Polaris, the SAP cloud application for the preparation and electronic submission of marketing authorisation dossiers.

more
21. November
DHC & LSA Web session (in German)

SAP S/4HANA Transformation and Validation with VITAL Process Model for Life Sciences

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

more
29. November
DHC & LSA Web session (in German)

SAP S/4HANA implementation and validation with the ‘VITAL’ process model for life sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

more
13. December
DHC web session (in German)

GxP-compliant validation of AI applications

We explain how the V-model for validation needs to be adapted to address AI-specific issues.

more
25. January
DHC web session (in German)

Valid SAP ERP operation with DHC Managed Validation Services – a case study

Find out what customised Managed Validation Services can include and what benefits they offer.

more
DHC WEB SESSIONS

Our web sessions are provided as a free service for DHC customers and potential customers.