PAS-X

NEWS
EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

Dear customers, Together with you, we strive to deve-

lop innovative software products that
What do a jogger wearing an activity tra- address your challenges and pave the
cker on his wrist and a machine in phar- way for Industrie 4.0 in Pharma.
ma production have in common?
Currently we are realizing together with cy of production performance. Based on
Both supply digital data to a system that partners, industry organizations and cus- our latest technology platform, it is ca-
enables performance optimization. This tomers a new standardized interface for pable of seamlessly integrating data from
is a very simple example of the digitaliza- the message-based data exchange bet- both the ERP and machine levels.
tion in all areas of our lives and how intel- ween Level 3 and Level 2. It will support
ligent IT solutions can help you become all kinds of Level 2 systems, no matter In recognition of our innovations, Werum
a bit better every day. if its OEE data from packaging machi- was acknowledged with the Asian Ma-
nes, EBR data from DCS systems or nufacturing Award as Best Pharma So-
Track&Trace data from line controllers. lutions Provider. Read more about the
award on the back page.
CONTENTS
An example of our integrated solution is
ASTRAZENECA, AUSTRALIA 2 the use case for parenteral manufactu- In this newsletter, you will also find some
ring displayed at the User Group Meeting, examples of our customer projects and
POLPHARMA, POLAND 2
which covers the entire value chain and more information about our solutions.
BOEHRINGER INGELHEIM, AUSTRIA 3 includes PAS-X and our partners: from I hope you will enjoy it.
Sartorius FlexAct system and ABBs pro-
TARO PHARMACEUTICAL
INDUSTRIES, CANADA 3 cess control system through mobile Sys Yours sincerely
tec & Solutions trolleys to Seidenaders
ALMIRALL, GERMANY 4 inspection solution and Dividellas pa-
MUSTAFA NEVZAT, TURKEY 4 ckaging machine. This is complemented
by one of our next generation software
TEVA PHARMACEUTICAL products the new Version 2.1 of PAS-X Rdiger Schlierenkmper
INDUSTRIES, USA 5
KPI for significantly improved transparen- CEO Werum IT Solutions GmbH
ACINO, SWITZERLAND 5

LEVEL 2 INTEGRATION 6

PAS-X KPI 7

ENDORSED SERVICE PARTNERS:

NNE PHARMAPLAN AND ZENITH 8

WERUM LOCATION IN THAILAND 9

STRATEGIC PARTNER:
SARLA TECHNOLOGIES 9 WERUM IT SOLUTIONS WINS
REGULATORY AFFAIRS 10
ASIAN MANUFACTURING AWARD

MBR DEVELOPMENT 11 Best pharma solutions provider

ASIAN MANUFACTURING AWARD 12

Read more on back page

 EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

ASTRAZENECA, AUSTRALIA

ASTRAZENECA DEPLOYS WERUMS PAS-X MES

TO REPLACE SAP PROCESS INSTRUCTION SHEETS
Rollout in North Ryde, Australia, without disruption to running operations /
GMBR approach reduces maintenance efforts for new and existing recipes

and execution. They decided to replace efforts in custom software development.

AstraZeneca Australia successfully put
Werums PAS-X MES into operation at
their site in North Ryde. The plant previ-
ously had a suite of legacy IT solutions in
place including a custom SAP PI Sheet
for the entire production management
the legacy ERP system as part of a glo-
bal finance restructuring and IT standar-
dization plan and due to the high risks
to maintain this software in a GMP envi-
ronment.
The first step was to implement PAS-X to
be integrated into the legacy ERP, then to
move all products in a phased approach
over to the MES and finally to realize a
new interface of the MES to connect with
the new regional ERP solution without
any disruption to running operations. The
highly standardized PAS-X MES allowed
the project through configuration to be
implemented without the need for costly
One key element was to leverage the
Generic Master Batch Records (GMBR)
functionality. The result was that approx.
100 different products across a wide
range of production methods (respules,
polybags, vials, ampoules) and process
variations (mother-daughter, campaign,
media, batching productions) can now
be handled with only 13 generic recipes.
PAS-X entirely replaced the legacy weig-
hing and dispensing system and the
custom SAP PI Sheets. It also provides
a standard interface to the new regional
AsiaSAP ERP system.

POLPHARMA, POLAND

LARGEST POLISH PHARMACEUTICAL MANUFACTURER

INTRODUCES WERUMS PAS-X MES
Implementation in Starogard Gdaski production plant, Poland / Full-scope PAS-X MES out of the box /
Compliance with approving authorities and improved process and product quality

Polpharma will introduce Werums P AS-X
MES in its production facility in Staro
gard Gdaski, Poland. The company is
the largest Polish manufacturer of phar-
maceuticals and ranks among the top 20
generic drug manufacturers worldwide.
Polpharma manufactures a wide range of
prescription drugs and pharmaceuticals
for in-patient care.
Werums PAS-X will be implemented as
full-scope MES out of the box replacing a
legacy MES. It will support efficient ope-
rations in the production departments for
parenteral and solid forms as well as in production and warehouse operators in
the R&D department. PAS-X shall be fully all production and storage operations
integrated with the Oracle ERP and WMS thus enabling a higher process and pro-
system and the scales on the shop floor duct quality.
level.
We decided in favour of Werums PAS-X
MES because it meets all requirements
set forth by the approving authorities
such as the FDA and the EU GMP gui-
delines, says Artur Poom, Solid Forms
Production Department, Polpharma S. A.
This decision was backed by a business
benefit analysis. PAS-X will support our

2 | WERUM
 PAS-X
NEWS

BOEHRINGER INGELHEIM, AUSTRIA

WERUM RECEIVES MAJOR ORDER FROM

BOEHRINGER INGELHEIM: PAS-X FOR NEW BIOTECH PLANT
Boehringer Ingelheim builds industrial-scale production plant for biopharmaceutical active ingredients
in Vienna / Latest version of Werums PAS-X MES will control complex process workflows

PAS-X 3.2
Boehringer Ingelheim (BI) commissioned
Werum IT Solutions with the implementa-
tion of an MES to control the pharmaceu-
tical production in their new plant in Vien-
na, Austria.
BI erects an industrial-scale biophar-
maceutical production plant in Vienna for
active ingredients which will be produced
using cell cultures. The MES will control
complex workflows across the entire The MES implementation in Vienna will be
process chain from the inoculum to the performed on the basis of the latest PAS-
filling. X product version which is also intended
to replace the existing PAS-X systems at
The operation of Werums PAS-X MES other BI sites in the following years.
has already led to efficiency improve-
ments at other BI sites. In addition, PAS-
X supports BI in meeting regulatory re-
quirements for the biopharmaceutical
production.

TARO PHARMACEUTICAL INDUSTRIES, CANADA

SUN PHARMA SUBSIDIARY TRUSTS IN WERUMS

PAS-X MES FOR GENERIC MANUFACTURING
PAS-X implementation at the strategic manufacturing site in Brampton, Ontario, Canada

Taro Pharmaceutical Industries, a subsi-
diary of the worlds fifth largest generic
drug manufacturer Sun Pharma, has se-
lected PAS-X for an MES pilot project at
their manufacturing site in Brampton, On-
tario. Here, the company produces gene-
ric liquids, crmes and ointments. Taro is
a multinational pharmaceutical company,
dedicated to meeting the needs of its
customers through the development and
manufacturing of healthcare products.
The initial implementation scope will co-
ver Weighing & Dispensing and Electro-
nic Batch Recording for compounding,
filling, and packaging of one product fa-
mily. Later, the system will be extended
to a full-scope MES. PAS-X will fully in-
tegrate Taros ERP system with the au-
tomation and equipment level to ensure
efficient and compliant data transfer.
With PAS-X we aim to achieve a Right
First Time factor of over 99 percent.
Werums MES will ensure compliance
and certainty of our manufacturing data
a prerequisite for improved process intel-
ligence. Additionally, we will accomplish
shorter cycle and review times. PAS-X
will enable us to better utilize our resour-
ces leading to a better cost effective
ness, says Daryl LeSueur, Vice Presi-
dent, Brampton Site Head.

WERUM | 3
 EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

ALMIRALL, GERMANY

LEADING MANUFACTURER OF SKIN MEDICINE

OPTS FOR WERUMS PAS-X
Rollout in German plant in Reinbek near Hamburg / Established implementation method
and convincing process know-how as crucial factors

In the context of a tendering process, the Spanish pharmaceu-
tical company Almirall opted for Werums PAS-X MES to be in
stalled in the German plant in Reinbek near Hamburg. Almirall is
the market leader for skin medicine in Germany and e.g. produ-
ces the Balneum skin care products.
PAS-X will be rolled out as a full-scope MES for the entire ma-
nufacturing process including weighing, mass production and
packaging. It will replace the legacy production management
system. The new review and release workflows will lead to more
effective processes as well as compliance with regulatory requi-
rements.
PAS-X will be implemented out of the box and according to
Werums unique implementation method Ready Fit Build
Run. The benefit for Almirall: short project term and significant
cost efficiency.
We are already thrilled about the Fit Phase, says Maik Weber,
Head of Production at Almirall. Together with the Werum con-
sultants we matched our business processes in the Reinbek
production site with the best-practice-based PAS-X workflows.
Both the approach and the expertise of the consultants and the
results of this phase were really convincing!

MUSTAFA NEVZAT, TURKEY

RELEASE OF WERUMS PAS-X AT LEADING

TURKISH PHARMA MANUFACTURER IN ONLY SIX MONTHS
Mustafa Nevzat introduced Werums PAS-X Weighing & Dispensing at site in Istanbul /
Improved quality and regulatory compliance / Full SAP integration

Mustafa Nevzat Pharmaceuticals has
successfully taken Werums PAS-X Weig-
hing & Dispensing into operation at their
main manufacturing site in Istanbul, Tur-
key. The pharmaceutical company is an
Amgen holding representing one of the
leading Turkish manufacturers of active
pharmaceutical ingredients and finished
dosage forms.
At the Istanbul site, Mustafa Nevzat has
been started to refurbish the main pro-
duction plant dedicated to the manufac-
turing of sterile liquid and freeze-dried
injectable products, tablets, film-coated
tablets and capsules. Several new clean-
room booths for weighing, dispensing cals. The new electronic workflows will
and sampling were put up and outfitted replace paper-based execution and en-
with Werums PAS-X. sure improved process and product qua-
PAS-X Weighing & Dispensing was im- lity.
plemented mainly out of the box within In a next step, PAS-X Weighing & Dispen-
six months. It communicates with Mett- sing will be extended to a full-scope MES
ler Toledo scales and fully integrates the covering further manufacturing areas.
SAP ERP through its certified, configura-
ble standard interface.
We have opted for the introduction of
Werums PAS-X in our weighing areas
to improve efficiency and compliance
with regulatory requirements, says On-
gun Akersin, Process Technologies Team
Leader at Mustafa Nevzat Pharmaceuti-

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 PAS-X
NEWS

TEVA PHARMACEUTICAL INDUSTRIES, USA

WORLDS LARGEST MANUFACTURER OF GENERIC DRUGS

USES PAS-X TRACK&TRACE FOR PACKAGING SERIALIZATION
Low implementation and validation efforts due to selecting a standard product/
Rollout to packaging lines in Northern America and Europe

In the context of their global serialization
program, Teva Pharmaceutical Industries
will roll out PAS-X Track & Trace at va-
rious sites in Northern America and Eu-
rope. Teva is the worlds largest generic
medicines producer with a world-leading
position in innovative treatments for dis-
orders of the central nervous system as
well as a strong portfolio of respiratory
products.
For labeling and tracking their products,
Teva needed a flexible IT solution to
comply with the legal regulations of the
countries in which the medical products
are sold. The solution was to be based
on a standard product to ensure a quick
implementation and simple future up-
grades.
PAS-X Track & Trace covers all applicable
legal regulations and can be adjusted
to future requirements. It will be imple-
mented widely out of the box and as a
standalone solution. PAS-X Track & Tra-
ce will integrate the SAP ATTP and Optel
Visions packaging lines.

ACINO, SWITZERLAND

LEADING CONTRACT MANUFACTURER STARTS UPGRADE

TO LATEST PAS-X VERSION WITH TRACK & TRACE
Start of rollout in plant in Aesch, Switzerland / Seamless integration of SAP ATTP,
Seidenader and OCS across all four levels / MES planned to be extended to entire production in Switzerland

The rollout starts with the introduction of Werums Track & Trace
solution to packaging at the site in Aesch, south of Basel. This
decision was triggered by the regulatory requirements for labe-
ling and tracking of pharmaceutical products in Saudi Arabia
an important export market for Acino and their customers.

The out-of-the-box approach of PAS-X Track & Trace allows a

The Swiss pharmaceutical company Acino will gradually up-
grade to the latest version of Werums PAS-X MES in their Swiss
plants. Acino develops, manufactures and internationally mar-
kets well-proven and innovative pharmaceuticals in novel drug
delivery forms. Acinos pharmaceuticals are available around the
globe under the Acino Switzerland brand and, in certain coun-
tries, under the trademark of its partners.
fast implementation and easier upgrades to the latest versions
in the future. Track & Trace is interfaced with SAP ATTP which
supplies the serial numbers. On the shop floor level, PAS-X Track
& Trace integrates the Seidenader and OCS line controllers to
achieve a seamless information exchange across all four levels.
The gradual implementation will help us to gain experience with
the latest PAS-X version in a limited area, says Barthold Pie-
ning, COO at Acino. With this knowledge we can adapt our
processes before we will replace our old PAS-X system and roll
out the new version in the entire production of the Swiss sites.

WERUM | 5
 EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

READY FOR INDUSTRIE 4.0

LEVEL 2 INTEGRATION:
NEW INDUSTRY STANDARD FOR STRUCTURED L3-L2 DATA EXCHANGE
Introducing message-based data exchange / Cooperation with partners, customers and Medipak Systems
companies / Less effort and complexity for pharma and biotech companies

As part of its Industrie 4.0 initiative,

Werum IT Solutions, together with
partners, is currently working on a
new industry standard for the struc-
tured data exchange between Level 3
and Level 2.
The new message-based interface will support all kinds of
Level 2 systems, no matter if its OEE data from packaging
machines, Track & Trace data from line controllers or EBR
data from granulators or DCS systems.
Robert Welter, Senior Head of PAS-X Product Management,
Werum IT Solutions GmbH

On the basis of new technologies, like

OPC-UA, we will change the machi-
ne communication from bit-based to
message-based. The new message-
based interface will support all kinds
of Level 2 systems, no matter if its
OEE data from packaging machines,
Track & Trace data from line controllers
or EBR data from granulators or DCS
systems, says Robert Welter, Senior
Head of PAS-X Product Management,
Werum IT Solutions GmbH. For phar-
ma and biotech manufacturers the
new integration concept means less
effort for MBR creation and mainte-
nance.

Werum cooperates with several indus-

try initiatives, partners and customers
as well as across Medipak Systems.
Within ISPE, Werum has initiated the
foundation of a working group for the
topic IT Automation System Struc-
ture & Integration Standardization. As
member of Open-SCS, Werum encou-
rages the development of a standar-
dized exchange of serialization data.

In the context of the strategic cooperation with ABB, we are

building a joint MES-DCS solution. Within Medipak Systems
Werum IT Solutions

we are also working on the implementation of a solution for

the entire Medipak Systems business area.
Karl Hoffmann, Senior Director Marketing & Business Development,
Werum IT Solutions GmbH

6 | WERUM
 PAS-X
NEWS

MANUFACTURING INTELLIGENCE
OEE
NEW: WERUM IT SOLUTIONS LAUNCHES
STANDALONE VERSION OF ITS PAS-X KPI SOFTWARE
Lean KPI software product dedicated solely to pharma and biotech industries /
Real-time monitoring of KPIs such as OEE / Seamless integration of ERP and equipment level /
Cross-plant comparisons of performance data

Werum IT Solutions has released the PAS-X KPI automatically collects process visors can continuously view the up-to-
standalone Version 2.1 of its PAS-X KPI data related to Overall Equipment Effec- date status of their lines, including pro-
software product. PAS-X KPI is the only tiveness (OEE) in real time. Results are duction goals and target achievements.
KPI/OEE tool dedicated solely to the displayed on various monitors in easily Plant managers benefit from standar-
pharmaceutical and biopharmaceutical understandable terms to enable quick dized reports with aggregated operating
industries. It is capable of seamlessly decision making. Operators and super- figures for analyses in larger contexts.
integrating data both from the ERP level
and the machine level at the shop floor.
By allowing comparisons and evaluations
of operating data at production lines in
different facilities, it provides an enterpri-
se-wide, single source point of informa-
tion.

Werums KPI/OEE tool is browser-based

and supports multiple delivery methods,
including site installation and enterprise
cloud. It offers the option to scale up
MES functionality easily, e.g. Electronic
Batch Recording (EBR).

Providing significantly improved transparency on the shop floor,

PAS-X KPI helps plant managers take expedient, appropriate
measures to maximize production performance all without any
additional machines or operators.
Matthias Khler, Senior Head of Strategic Program Management,
Werum IT Solutions GmbH

The new PAS-X KPI is easy to deploy because it is a standalone

product independent from our PAS-X MES. Very interesting for
many of our customers is that we offer a trial proof of concept
installation: Pharma and biotech manufacturers can test PAS-X
KPI in their own production environment for a stated term.
Lars Hornung, Senior Director Global Sales,
Werum IT Solutions GmbH

Watch our video and

learn how to improve
your pharma OEE!

WERUM | 7
 EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

SERVICE PARTNER IN EUROPE, USA, CHINA

WERUM IT SOLUTIONS AND NNE PHARMAPLAN RENEW

LONG LASTING SERVICE PARTNERSHIP FOR EUROPE, USA AND CHINA
Pharma and biotech manufacturers benefit from best-in-class pharma MES combined with
local implementation support from PAS-X Endorsed Service Partner

The collaboration brings together our customers through reliable, expe-

Werum IT Solutions recertified NNE
Pharmaplan as Endorsed Service
Partner for Europe, the USA and Chi-
na. Thus, NNE Pharmaplan, an inter-
national company specialized in phar-
ma engineering, is qualified to support
pharma and biotech companies with
the implementation of Werums PAS-X
MES.
Werums PAS-X MES software with
NNE Pharmaplans expertise in phar-
ma engineering and customer service.
NNE Pharmaplan will provide local
support for Werum customers during
all MES implementation phases.
We have been successfully working
together with NNE Pharmaplan for
many years, says Torsten Isenberg,
Senior Director Services at Werum
IT Solutions GmbH. As an Endorsed
Service Partner, NNE Pharmaplan has
the knowledge to provide our custo-
mers with high quality professional ser-
vices and support. The main objective
of our PAS-X Service Partner Program
is to ensure a high level of support for
rienced and certified partners.
Sren Mordhorst, Manager Manu-
facturing IT at NNE Pharmaplan A/S,
adds: We are pleased to have rene-
wed our partnership and to have cer-
tified PAS-X specialists throughout
Europe, USA and China. Given our
broad expertise within automation
and IT in modern pharma production
we can provide customers with con-
sultancy and implementation services
from the conceptual design phase to
implementation, ensuring a high level
of support on the PAS-X part as well.

SERVICE PARTNER IN EUROPE AND USA

WERUM AND ZENITH ANNOUNCE GLOBAL MES PARTNERSHIP

Customers benefit from best-in-class pharma MES combined with local implementation support

Zenith Technologies and Werum IT
Solutions formed a partnership to
support pharma companies with the
implementation of MES to improve
production performance. The collabo-
ration combines Werums PAS-X with
Zeniths ability to integrate systems
and provide on-the-ground automati-
on technical support.
The partnership makes Zenith an En-
dorsed Service Partner of Werum
in the USA and Europe. Zenith will
support Werum customers during all
MES implementation phases, delive-
ring comprehensive support and con- the collaboration represents a strate-
sultancy services that complement gic move. By combining Werums MES
Werums solutions. with our technical implementation ex-
We are delighted to partner with perience, we can provide customers
Zenith Technologies, says Torsten with a high quality of service, training
Isenberg, Senior Director Services at and local level support.
Werum. As an Endorsed Service Part-
ner, Zenith has the expertise required
to be part of our PAS-X service partner
program.
Brendan ORegan, chair and founder,
Zenith Technologies: Given our com-
bined knowledge in automation and
the similarities in our customer base,

8 | WERUM
 PAS-X
NEWS

NEW WERUM LOCATION IN THAILAND

WERUM EXTENDS PRESENCE IN ASIA PACIFIC BY

ACQUIRING FACTORYTALKS MES BUSINESS
Fully integrated and comprehensive solution hub for the benefit of Werums existing and new clients in Asia

Werum IT Solutions and Factorytalk
Co., Ltd., Thailand, a leading consulting
company for pharma manufacturers in
Southeast Asia, agreed on the comple-
te transfer of Factorytalks MES business
to Werums corporate organization. All
Factorytalk MES employees many of
whom are long-term experienced MES
experts transferred into the newly es-
tablished subsidiary Werum IT Solutions
Ltd. in Bangkok, Thailand. This ensures
continuation and is the sound basis for
future growth of the operational Werum
business in the Asia Pacific region.
Factorytalks ten year long collaboration
with Werum and proven track record of
success in implementing Werums PAS-X
MES working with qualified locally based
consultants are the solid platform on
which the business transfer was built.
Through this initiative Werum can thus
provide a fully integrated and compre-
hensive solution hub for the benefit of
Werums existing and new clients in Asia.
This deal is about market leadership and
growth. We highly welcome the opportu-
nity to expand our local activities for Asian
customers in this important future market
together with Factorytalk a company
with outstanding PAS-X MES and com-
pliance expertise, says Rdiger Schlie-
renkmper, CEO, Werum IT Solutions
GmbH. The transfer of Factorytalks
MES business to Werum is an important
step forward in realizing our future busi-
ness growth strategy in the region.
For over ten years we have greatly va-
lued and been proud to work in such a
close and rewarding partnership with
Werum, says David Margetts, now ap-
pointed Managing Director of the newly
founded Werum IT Solutions Ltd., for-
merly Managing Director Factorytalk Ltd.
Lars Hornung, Senior Director Global
Sales, Werum IT Solutions GmbH, adds:
Werums new Asia hub in Thailand is
the first step in our pursuit to be closer
to our customers in this region. Our new
Werum office in Bangkok will be a center
of excellence for MES projects of pharma
and biopharma clients in the Asian Paci-
fic region. It will also be a first milestone
on our way of establishing further offices
in key markets in Asia. This will clearly
enable us to serve our customers in the
region even better than in the past.

PARTNER IN INDIA

BOOSTING PAPERLESS MANUFACTURING:

STRATEGIC PARTNERSHIP WITH SARLA TECHNOLOGIES
Werum and Sarla to partner for delivering MES projects in India / Multinationals and local pharma
companies benefit from PAS-X MES solution and smooth integration of the automation level

Werum IT Solutions and Sarla Technologies signed a me-
morandum of understanding to partner for delivering MES
projects in India. Thus, Sarla Technologies is an official part-
ner for Werums PAS-X MES throughout India providing pro-
ject control and integration services.
Were very pleased that Sarla Technologies joined us as
a partner to expand our presence in India and to leverage
their great experience and track record in the Indian phar-
ma industry and also in automation and process control for
projects requiring complete integration with machines and
equipment, says Lars Hornung, Senior Director Global Sa-
les, Werum IT Solutions GmbH. Together with Sarla Tech-
nologies we are able to offer our best-in-class PAS-X MES
package together with an optimized deployment model to
our customers in India.
Mr. Anil Mehta, CEO, Sarla Technologies, adds: Our part-
nership with Werum enables multinationals and leading local
pharmaceutical companies in India to gain full advantage of
MES. PAS-X and Werums expertise along with Sarlas Level
2 integration and automation know-how will tremendously
help them to increase productivity and meet global regula-
tory requirements.

WERUM | 9
 EMPOWERING TODAY. SHAPING THE FUTURE. TOGETHER.

REGULATORY AFFAIRS

RI MANAGER SUPPORTS EFFICIENT MANAGEMENT

OF REGULATORY INFORMATION
Centralized Regulatory Information Management (RIM) solution to efficiently
manage your regulatory data, activities, processes, submissions and commitments

RImanager is a centralized master data driven Regulatory Infor- built-in task management tools, you can assign specific activities
mation Management solution based on PAS-X, which provides to departments or teams of users. Direct links between tasks
organizations the capability to manage their product portfolio and business objects such as manufacturing sites, products,
with effortless compliance. It allows you to manage your master formulations or submission documents allow quick access to
data as well as to plan and track related regulatory data, activi- related objects. For more complex processes, RImanagers
ties, processes, submissions and commitments across depart- workflow engine enables you to assign tasks in sequence to a
ments on a global scale. number of users. The fully audited workflows can also be used
to manage review and approval processes.
Connecting your regulatory and production processes
RImanager manages all your product master data. Regulatory
activities can be defined that store and track the information re-
lated to each product and its related submissions. As RImanager
is built upon PAS-X, it can also be integrated tightly into your ma-
nufacturing processes. This ensures that information regarding
labelling, formulation and drug safety remain in a single reposi-
tory, allowing instant access for your end-users and providing
essential management and regulatory reporting capabilities.

Effectively manage your regulatory projects

RImanager also includes a set of project management tools to
help you to structure your overall regulatory processes. Using the

GO-LIVE OF RI MANAGER AT HEEL

Werum has successfully implemented
RImanager at the pharmaceutical com-
pany Biologische Heilmittel Heel. Heel
develops, manufactures and distributes
medicines based on natural substances.
The company is a pioneer in the field of
scientific research in natural healthcare.
Most known medicines are Traumeel,
Zeel, Engystol, Euphorbium, Viburcol,
Neurexan, Vertigoheel and Spascupreel.
In several stages, Werums RIM solution
has replaced an outdated system and
has become the most important IT pro-
ject in recent years at Heel after the im-
plementation of SAP. The regulatory da-
tabase contains all product data related
to drug-approval and allows managing
approval and authority activities e.g. if
a medical product in a country has to be
resubmitted or if the approval needs to be
renewed. Key functions are the Product
Dictionary to manage the products and
product characteristics including all drug
approval information as well as the Plan-
ning and Tracking-tool to plan, organize
and track authority activities e.g. in the
case of new applications, renewals and Further references
product variants.

10 | WERUM
 PAS-X
NEWS

MBR DEVELOPMENT

WERUM IT SOLUTIONS INTRODUCES NEW SERVICE FOR THE

COST-EFFECTIVE, HIGH-QUALITY AND LARGE-SCALE MBR CREATION
Design as a Service offers the customer-specific MBR creation and the efficient operation of Werums PAS-X MES

Development of new drugs, process har-

monization and standardization or effici-
ent operation of MES pharmaceutical
and biopharmaceutical companies face
major challenges to remain competitive.
In this regard, electronic MBRs are an es-
sential factor.

Werum IT Solutions now offers its cus-

tomers a new service: Design as a
Service a complete solution for the
cost-effective creation of lean, high-
quality and s treamlined MBRs. The pa-
ckage comprises pre-configured PAS-X
Content Packages with industry-specific
content based on best practices, ready-
to-use concepts and guidelines for the
efficient creation and optimization of
MBRs and profound, first-hand PAS-X
knowledge. As the company which de-
veloped P AS-X, Werum is able to provide
an end-to-end MES solution that meets
all customer requirements in terms of
software, delivery and services.
Through Design as a Service, Werum
does not only support the cost-effective
high-quality creation of MBRs for new
MES installations but also supports cus-
tomers who already operate an MES and
rather focus on process harmonization,
PAS-X upgrades or the MBR creation for
new products (ad-hoc service). As PAS-X
is Werums proprietary software product,
Werum can also consider future PAS-X
functions when creating MBRs. Design
as a Service addresses all phases of
MBR development, such as MBR spe-
cification, MBR creation and finally MBR
verification. The resulting MBRs are lean,
efficient and optimized to meet the cus-
tomer requirements in regard to Review
by Exception.
Our Design as a Service offering allows us to provide our phar-
maceutical and biopharmaceutical customers with much more
than the mass conversion of paper-based recipes into digital
copies which is usually referred to as MBR factory.
Lars Sding, Head of Consulting & Training,
Werum IT Solutions GmbH
Our approach starts at an earlier stage need to revise their MBRs, says Lars
and we reflect about the manufacturing Sding, Head of Consulting & Training at
processes together with our customers. Werum IT Solutions GmbH.
Even during the MBR specification pha-
se we consider the entire spectrum
of manufacturing procedures, system
environment and review processes. In
combination with the profound process
know-how of our staff we ensure opti-
mized high-quality MBRs from the very
beginning an important prerequisite
for the efficient operation of our PAS-X
MES. Customers who want to save costs
by commissioning the mere creation of
MBRs often face extra costs when they

WERUM | 11
 PAS-X
NEWS

BEST PHARMA SOLUTION

WERUM IT SOLUTIONS WINS

ASIAN MANUFACTURING AWARD 2016
Recognition as Best Pharma Solutions Provider / Motivation to continue developing innovative,
high quality software that addresses pharma industry challenges

Werum IT Solutions has been named

Best Pharma Solutions Provider at this A special thank you to our customers. The award motivates us
years Asian Manufacturing Award cere- to continue developing innovative, high quality software products
mony. With this, the deciding jury of in- that address the challenges of the pharma industry.
dustry experts acknowledged Werums Rdiger Schlierenkmper, CEO
Werum IT Solutions GmbH
innovations and continuous advance-
ment of its PAS-X MES. Its specialized
solutions help pharma manufacturers in
Asia increase efficiency, improve produc-
tivity, and meet regulatory requirements.

A special thank you to our customers,

because they are the foundation for this
recognition, says Rdiger Schlierenkm-
per, CEO of Werum IT Solutions GmbH.
We are very proud to be recognized as
Best Pharma Solutions Provider for our
PAS-X manufacturing IT product and ser-
vices offering. The award motivates us
to continue developing innovative, high
quality software products that address
the challenges of the pharma industry
such as Manufacturing Intelligence and
Industrie 4.0 together with our custo- Earning the Asian Manufacturing Award is a remarkable achieve-
mers. ment we want to share with our customers.
David Margetts, Managing Director
Werum IT Solutions Ltd., Thailand
David Margetts, Managing Director,
Werum IT Solutions Ltd., Thailand, who
received the Asian Manufacturing Award
during the gala ceremony in Singapore,
adds: Earning the Asian Manufacturing The Asian Manufacturing Award honors First held in 2012, the annual competition
Award is a remarkable achievement we control, instrumentation, and automation is organized by Contineo Media, publis-
want to share with our customers, part- product manufacturers and service pro- her of high-circulation Asian trade maga-
ners and employees. We would like to viders who have delivered the best solu- zines such as Pharma Asia and Control
thank all of our customers for their trust tions to address todays engineering and Engineering Asia.
and commitment. manufacturing challenges.

IMPRINT: Werum IT Solutions GmbH (Global HQ) Wulf-Werum-Str. 3 21337 Lneburg Germany
T +49 4131 8900-0 F +49 4131 8900-200 info@werum.com www.werum.com Werum IT Solutions