19.06.2018 Aufrufe

ARCONDIS UPDATE No. 02|2018: GxP Compliance to the point

ARCONDIS Kundennewsletter für den Themenbereich Compliance in Medizinprodukteunternehmen

ARCONDIS Kundennewsletter für den Themenbereich Compliance in Medizinprodukteunternehmen

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14_<strong>GxP</strong> <strong>Compliance</strong> <strong>to</strong> <strong>the</strong> <strong>point</strong> 15<br />

konfrontiert und noch kann aus dem potenziellen<br />

Risiko eine Chance für nachhaltige<br />

Erneuerung gemacht werden.<br />

Erfolgreicher Umstieg auf SAP<br />

S/4 HANA – Gründe aus der<br />

Praxis<br />

Auch für Nicht-SAP-Kunden kann ein Wechsel<br />

der ERP-Landschaft hin zu S/4 HANA<br />

Vorteile bieten, wie folgendes Praxisbeispiel<br />

zeigt. In 2017 leitete <strong>ARCONDIS</strong> ein<br />

ERP-Evaluationsprojekt bei einem mittelständischen<br />

Schweizer Biotech-Unternehmen. Es<br />

galt, die Kombination aus Eigenentwicklung<br />

und KMU-Lösung durch ein modernes, das<br />

Wachstum des Unternehmens begleitendes<br />

ERP zu ersetzen.<br />

Durch die Spezialisierung auf die Life<br />

Sciences Industrie und das damit verbundene<br />

Know-how wurde <strong>ARCONDIS</strong> neben<br />

der Verantwortung für den Auswahlprozess<br />

auch mit der Business-Analyse und dem<br />

Anforderungsmanagement betraut. Nach<br />

Abschluss der Evaluation entschied sich der<br />

Kunde auf Basis der transparenten Entscheidungsmatrix<br />

für SAP S/4 HANA in Kombination<br />

mit weiteren SAP-Komponenten,<br />

wie beispielsweise SuccessFac<strong>to</strong>rs für das<br />

Human Capital Management und SAP Cloud<br />

Platform Integration für die Einbindung von<br />

Cloud- und On-Premise-Applikationen.<br />

Ausschlaggebend waren insbesondere:<br />

Hoher Grad funktionaler Abdeckung, speziell<br />

im Bereich länderspezifische Anforderungen,<br />

Architektur basierend auf innovativer<br />

In-Memory-Technologie,<br />

Zukunftsorientierung der Gesamtlösung<br />

im Hinblick auf Digitalisierung, Vernetzung<br />

und Mobilität,<br />

Benutzerfreundlichkeit durch Fiori-Apps<br />

und<br />

Embedded Reporting und Analysefunktionalitäten.<br />

Das Projekt befindet sich nun, unter weiterer<br />

Beteiligung von <strong>ARCONDIS</strong>, in der erfolgreichen<br />

Umsetzungsphase und wird Herbst<br />

2018 abgeschlossen.<br />

Wann beginnen Sie mit den Vorbereitungen<br />

für einen erfolgreichen Umstieg? Sprechen<br />

Sie uns gerne an, wir beraten neutral und<br />

SAP-unabhängig, damit Ihre Reise ein Erfolg<br />

wird und Sie langfristig von den Ergebnissen<br />

der Umstellung profitieren. Andreas Jung<br />

English<br />

E_As <strong>the</strong> global market leader of ERP<br />

software and with a wide range of software<br />

components for companies in virtually<br />

every industry, SAP is currently in<br />

a process of transformation. This change<br />

not only affects <strong>the</strong> company’s strategic<br />

alignment, but nearly its entire product<br />

portfolio – not without drastic effects for<br />

existing and future cus<strong>to</strong>mers.<br />

Set <strong>to</strong> take several years, <strong>the</strong> transformation<br />

process is primarily based on two main<br />

elements:<br />

The evolution of SAP SE in<strong>to</strong> a comprehensive<br />

cloud solution provider and<br />

<strong>the</strong> transformation, fundamental overhaul<br />

and porting of <strong>the</strong> entire SAP solution<br />

portfolio <strong>to</strong> <strong>the</strong> SAP HANA in-memory<br />

database technology.<br />

Many SAP cus<strong>to</strong>mers will have <strong>to</strong> address<br />

<strong>the</strong>ir own IT application landscapes – <strong>the</strong> life<br />

cycle for SAP’s main product, ERP platform<br />

SAP ECC 6.0 (Enterprise Core Component<br />

6.0) ends with <strong>the</strong> year 2025.<br />

Besides <strong>the</strong> challenges entailed by a major<br />

project such as ERP migration, this also<br />

offers cus<strong>to</strong>mers <strong>the</strong> opportunity <strong>to</strong> prepare<br />

important IT applications for <strong>the</strong> future.<br />

For <strong>the</strong> cus<strong>to</strong>mer’s sake, it is important <strong>to</strong><br />

ask <strong>the</strong> following key questions and prepare<br />

appropriate answers.<br />

What should <strong>the</strong> planned target IT architecture,<br />

IT landscape and <strong>the</strong> operating<br />

model look like in <strong>the</strong> future?<br />

What business functions should be supported<br />

by which IT applications?<br />

What drivers and effects does SAP transformation<br />

have, especially in terms of <strong>the</strong><br />

end of <strong>the</strong> SAP ECC 6.0 lifecycle in 2025?<br />

What does <strong>the</strong> IT roadmap for implementing<br />

<strong>the</strong> target IT architecture look like?<br />

What implementation approach is <strong>the</strong><br />

right one?<br />

What are <strong>the</strong> budget, resource, time<br />

requirements etc. for <strong>the</strong> years <strong>to</strong> come?<br />

For many companies, finding valid answers<br />

<strong>to</strong> <strong>the</strong>se questions requires <strong>the</strong>m <strong>to</strong> deal<br />

with very specific and in some cases complex<br />

<strong>to</strong>pics. The following starting <strong>point</strong>s<br />

and effects will show <strong>the</strong> importance of<br />

planning ahead and beginning on time in<br />

order <strong>to</strong> highlight <strong>the</strong> need for action for SAP<br />

cus<strong>to</strong>mers.<br />

SAP S/4 HANA and future<br />

prospects<br />

SAP ECC 6.0 will be discontinued by SAP<br />

SE at <strong>the</strong> end of 2025. For cus<strong>to</strong>mers, this<br />

means it can still be used, but only on an<br />

individual contract basis, and no longer<br />

with a set maintenance fee. In some areas,<br />

development was s<strong>to</strong>pped/reduced drastically<br />

years ago. This SAP product can no<br />

longer be recommended as an ERP platform<br />

for new projects or long-term use. Affected<br />

companies are forced <strong>to</strong> give thought <strong>to</strong> <strong>the</strong><br />

main elements of <strong>the</strong>ir IT landscape and<br />

switch <strong>to</strong> o<strong>the</strong>r products in <strong>the</strong> future.<br />

The question is not whe<strong>the</strong>r a migration is<br />

necessary, but “how?” and “when?”.<br />

SAP offers a successor product – SAP S/4<br />

HANA. S/4 HANA is based on SAP’s HANA<br />

in-memory database, and when finished it<br />

will present an all-new ERP solution. Besides<br />

<strong>the</strong> mentioned database technology, <strong>the</strong>se<br />

are just some of <strong>the</strong> major advantages and<br />

properties offered by S/4 HANA:<br />

Less complex data models <strong>to</strong> simplify and<br />

speed up business processes (already implemented<br />

in many areas, but not entirely<br />

for all business processes and functions<br />

at <strong>the</strong> current <strong>point</strong> in time)<br />

All-new user interface with SAP FIORI<br />

apps for simplified operation, <strong>to</strong>tally new<br />

look and feel<br />

Embedded analytics for comprehensive<br />

analyses and evaluations<br />

Various operating models and solutions<br />

(on-premise, private or public cloud solutions)<br />

New technological base architecture for<br />

innovations such as artificial intelligence<br />

(e.g. <strong>to</strong> clear incoming payments)<br />

The new technological HANA basis also enables<br />

integration with SAP solution platform<br />

Leonardo, laying <strong>the</strong> foundation for digitalization<br />

(for example for blockchain, <strong>the</strong> Internet<br />

of Things, etc.).<br />

S/4 HANA is being continuously developed<br />

and, as of <strong>the</strong> second quarter of 2018, it has<br />

reached a good degree of maturity, reflected<br />

in <strong>the</strong> number of cus<strong>to</strong>mer installations<br />

already implemented in many industries and<br />

countries. In individual cases, an analysis is<br />

required, investigating whe<strong>the</strong>r all important<br />

and relevant business processes with<br />

specific requirements, such as integration<br />

with o<strong>the</strong>r IT applications for HR, cus<strong>to</strong>mer<br />

management, and industry-specific requirements<br />

such as integration with lab software,<br />

clinical trials management systems (CTMS)<br />

or manufacturing execution systems (MES)<br />

are covered. This also makes it necessary <strong>to</strong><br />

take a look at <strong>the</strong> entire IT application landscape<br />

with all <strong>the</strong> required IT applications:<br />

What business functions have <strong>to</strong> be supported<br />

for <strong>the</strong> individual cus<strong>to</strong>mer situation with<br />

what IT applications? In <strong>the</strong> target architecture,<br />

S/4 HANA represents <strong>the</strong> core that has<br />

<strong>to</strong> be integrated with o<strong>the</strong>r components in<br />

order <strong>to</strong> achieve optimal process coverage,<br />

especially for <strong>the</strong> specific processes in <strong>the</strong><br />

life sciences industry.<br />

SAP operating models and <strong>GxP</strong><br />

When pondering an architecture, it also<br />

makes sense <strong>to</strong> consider possible operating<br />

models, as <strong>the</strong> trend is clearly heading <strong>to</strong>wards<br />

cloud solutions. More and more often,<br />

public clouds are coming in<strong>to</strong> use, as can be<br />

seen in <strong>the</strong> area of human capital management.<br />

Public clouds offer many advantages,<br />

such as fast rollout times, best practice<br />

approaches and a higher degree of standardization<br />

just <strong>to</strong> name a few. However, <strong>the</strong>y<br />

also have major quirks that should be looked<br />

at with a critical eye for <strong>the</strong> life sciences<br />

industry in particular, including manda<strong>to</strong>ry<br />

release changes each year and <strong>the</strong> associated<br />

testing. For this reason, use of <strong>the</strong> public<br />

cloud <strong>to</strong> support <strong>GxP</strong>-relevant processes in<br />

<strong>the</strong> SAP environment is difficult <strong>to</strong> imagine.<br />

To achieve a validated status, releases would<br />

at least have <strong>to</strong> be documented via regression<br />

testing within <strong>the</strong> few weeks that SAP<br />

gives between <strong>the</strong> release announcement<br />

and upload <strong>to</strong> <strong>the</strong> public cloud. This model is<br />

hardly practical in everyday operations.<br />

From practice, we are familiar with <strong>the</strong> first<br />

<strong>GxP</strong>-relevant SAP S/4 HANA implementation<br />

in <strong>the</strong> private cloud, for example in <strong>the</strong><br />

SAP HANA Enterprise Cloud. High testing<br />

and documentation requirements can be<br />

expected due <strong>to</strong> <strong>the</strong> necessary validation activities.<br />

In addition <strong>to</strong> validation, <strong>the</strong> following<br />

questions are also relevant for using “<strong>GxP</strong> in<br />

<strong>the</strong> cloud”:<br />

How is data availability ensured?<br />

Is <strong>the</strong>re sufficient protection against<br />

manipulation?<br />

Who is responsible for <strong>the</strong> data under<br />

which circumstances?<br />

These <strong>point</strong>s should be addressed during<br />

contract negotiations with <strong>the</strong> provider,<br />

including in <strong>the</strong> private cloud.<br />

The trend <strong>to</strong>wards growing mobility should<br />

also be considered in <strong>the</strong> <strong>GxP</strong> environment,<br />

regardless of <strong>the</strong> operating model selected.<br />

Companies that provide <strong>the</strong>ir users with SAP<br />

apps and dashboards on mobile devices,<br />

for example, should keep in mind that <strong>the</strong>y<br />

have <strong>to</strong> be qualified in <strong>the</strong> same way as <strong>the</strong><br />

infrastructure when processing or s<strong>to</strong>ring<br />

<strong>GxP</strong>-relevant data. A mobile device policy<br />

simplifies this.<br />

Tackling migration<br />

To migrate <strong>to</strong> SAP S/4 HANA, <strong>the</strong>re are<br />

various approaches: The “Brownfield”<br />

approach migrates from SAP ECC 6.0 <strong>to</strong><br />

S/4 HANA maintaining as much cus<strong>to</strong>mizing,<br />

development, data, permissions and<br />

functional coverage as possible. In contrast,<br />

<strong>the</strong> Greenfield approach involves a fully new<br />

implementation. Planning in phases enables<br />

companies <strong>to</strong> manage potential project risks.<br />

An exact plan has <strong>to</strong> be developed specific<br />

<strong>to</strong> <strong>the</strong> cus<strong>to</strong>mer.<br />

Fortsetzung<br />

Continuation

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