ARCONDIS UPDATE No. 02|2019: The smarter solution

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stellt und verifiziert. So konnten die Einhaltung
eines straffen Projektplans gewährleistet
werden und die Releases termingerecht
stattfinden.
Das Unternehmen hatte kurz vor Beginn des
Digital­Twin­Programms einen global harmonisierten
Validierungsansatz eingeführt,
diesen aber noch nicht in der Praxis erproben
können. ARCONDIS unterstützte daher
parallel zur Softwarevalidierung auch die
Feinjustierung des Validierungsansatzes und
sorgte insbesondere dafür, dass der Prozess
sowohl Anforderungen der Regulierungsbehörden
der USA als auch Europas abdeckt.
Dadurch erspart sich das Unternehmen
erhebliche Kosten, da die zentrale Validierung
nur einmal statt mehrfach, also pro Standort,
durchgeführt werden muss.
Blick in die Zukunft
Dank der agilen Entwicklung ist der Digital
Twin bereits heute Realität: Wesentliche Teile
des Systems sind implementiert, validiert
und an sechs Standorten in den USA, Europa
und Asien im Einsatz. Das erlaubt Forschung
und Produktion den Austausch von Dokumenten
in Echtzeit und vereinfacht die
internationale Zusammenarbeit enorm.
Im Frühjahr 2019 erfolgte der fünfte Release
und binnen zwei Jahren ist das System
vollständig mit allen Funktionen angereichert
und an über vierzig Produktionsstandorten
weltweit produktiv. Christian Thome
English
E_Digital twins are virtual representations
of physical products, systems and
processes. The physical counterpart can
already exist or still be in development.
Many life sciences companies are taking
advantage of this NASA technology to
reap its benefits.
Product development teams are frequently
scattered across multiple continents, while
the production itself takes place in a wide
range of locations. What are the consequences
of this? Many employees require
simultaneous access to up-to-date product
data for specific use cases in order to process
and use their digital tools effectively.
The digital twin is an ideal aid for compliance
with regulatory requirements such as DHF
(Digital History File), DMR (Device Master
Record) or BOM (Bill of Materials).
The digital twin as a single
point of truth
A globally leading provider of products and
services for patients with chronic organ failure
wanted to take advantage of the digital
twin system. A suitable system solution
was chosen as a single point of truth for the
development, production, change management
and maintenance of all products. It
represents the product structure (through
modules and individual components)
electronically as a digital twin. The interface
makes it possible to expand each product
like a tree structure and gain a detailed
insight down to the individual component
and software solution used. Corresponding
product documentation was attached to
every level of detail.
The introduction of this system made it
necessary to validate all system components
along standard operational procedures, customer
standards and in compliance with all
relevant regulatory requirements.
Harmonization of vastly
different QMS and processes
ARCONDIS supported the roll-out of the
product life cycle management system from
the development onwards. It advised both
the manufacturer of medical devices and
the software implementation partner on the
specification of all requirements. The early
integration of compliance and validation
aspects is an important factor in the fast,
smooth implementation of a system developed
with agile methods. Ideally, this should
also involve consultants who can take said
aspects into consideration and apply them in
an agile environment.
What sounds like a simple task can be highly
challenging in our global reality. Not only
did the decades-old product management
structure still include many paper-based
processes without uniform filing systems,
which made global collaboration a lot more
difficult, there was also no globally harmonized
quality management system available
that could be used for the validation. The lack
of such a QMS is a common side-effect of
the rapid growth and extensive mergers and
acquisitions happening throughout the industry
today. This made it necessary to harmonize
the standards and processes of all
global sites before developing and applying
a harmonized validation approach – despite
different QMS.
In order to meet the requirements of the
GxP-regulated industry and, in particular, ISO
standard 13485 for the design and production
of medical devices, the company turned
to ARCONDIS, its experienced partner and
expert in quality control and validation.
Pragmatic: parallel,
not sequential
Instead of a classic, sequential validation
approach, ARCONDIS chose a more suitable
way: relevant validation documents such as
user requirements specifications (URS), design
specifications (DS) and others were created
and verified in parallel in advance. This
ensured adherence to an ambitious schedule
and the timely release of the system.
Shortly before embarking on the digital twin
program, the company had launched a globally
harmonized validation method which it
had not yet tested in practice. While carrying
out the software validation, ARCONDIS
simultaneously supported the fine-tuning of
that validation method. It ensured that the
process met the regulatory requirements
both of the US and Europe. This saves the
company considerable costs: the central validation
only needs to take place once rather
than multiple times, i.e. once per site.
A view to the future
Thanks to agile development, the digital twin
has become reality: significant chunks of the
system have been implemented and validated.
They are already in use at six sites in the
US, Europe and Asia. Research and production
departments can exchange documents
in real time, which simplifies their international
collaboration enormously.
In spring 2019, the fifth release took place.
Over the course of just two years, the system
will have acquired all available functions.
It will be working productively at more than
40 production sites worldwide. Christian
Thome