Pharma Software

Save time &

effort and
avoid risk
Werum PAS-X MES helps you to
digitize your pharma and biotech
production
100 % focused
on pharma and
biotech
You want to improve efficiency and compliance in
your factory? We are the leading supplier of
software solutions for pharma, biotech and cell &
gene. The core of our offering is PAS-X – the market
leading pharma MES software – combined with
content and services out of the box.

ROI in 2-3 years You worry, that your paper-based processes

PAS-X helps pharma-
are too slow, error-prone and inefficient and
ceutical and bio-
pharmaceutical might not comply with regulatory guidelines?
manufacturers to
At Körber, we understand that you are dissatis-
increase efficiency,
improve productivity, fied with the traditional, paper-based way of your
and meet regulatory
batch execution and documentation processes
requirements.
On average, a return and need to produce more efficiently. You have
on investment is
to innovate while ensuring GMP-compliant
achieved within two
to three years. manufacturing processes and the integrity of
your data.

Introducing our PAS-X Manufacturing

Execution System – enabling the digitization
of your pharma and biotech production
PAS-X is run by the majority of the world’s top
30 pharmaceutical and biopharmaceutical Supporting data integrity
companies and by many regional and mid-sized PAS-X supports data integrity requirements put
enterprises around the globe. With PAS-X, we forward by regulatory bodies such as the FDA,
provide the leading MES product for pharma- EMA, CFDA and WHO through:
ceutical and biopharmaceutical manufacturing –
enabling a fast implementation and providing • Best-practice business process
complete out-of-the box functionality tailored harmonization per product and across sites
to industry-specific needs. • Accurate data capturing and control
strategy execution
In line with regulatory requirements • ALCOA implemented for raw data, meta data
PAS-X meets all requirements set forth by the and true copies for data retention
approving authorities for operating computer • Secure data access and system-controlled
systems in regulated industries. This includes data review
the EU GMP guidelines, the GMP Annex 11 for
Computerized Systems Guidelines and the FDA
guidelines 21 CFR Part 11 and 21 CFR Part 210/211.

2 Pharma Software
One community 1,000+ installations at large multinationals as
The PAS-X users
well as regional and mid-sized enterprises
represent the
largest pharma MES Among our references are many of the largest
community worldwide.
and most demanding pharmaceutical manu-
facturers worldwide who deployed PAS-X as
their standard MES in large installations and
cooperate with us on a strategic basis. The
majority of the top 30 companies selected
PAS-X to improve their production perfor-
mance and compliance.

It is an important sign of our strength and capa-

bility that not only large multinationals are gain-
ing the benefits of the PAS-X MES but that we
have also implemented many successful solu-
tions for leading regional and mid-sized enter-
prises in Europe, North and Latin America and
Asia Pacific.
PAS-X MES –
PAS-X is built together with our customers
The PAS-X users represent the largest pharma the first step to
MES user community worldwide. Many of our
customers are also members of the PAS-X User
your digital
Forum “PAS-X For Us” (PFU). They actively parti-
cipate in advancing the development of the
pharma factory
PAS-X MES, thus ensuring that the PAS-X product
is based on the best practices of the pharma-
ceutical and biopharmaceutical industries. International network of excellence
We at Körber provide in our Business Area
Join our PAS-X User Group Meetings Pharma a unique combination of process know-
Our customers regularly come together at the how, software, and cutting-edge technology -
annual ­PAS-X User Group Meetings in Europe offering holistic solutions for safe and efficient
and the USA. Join our next User Group Meeting processes in the manufacturing, inspection, and
and learn more about case studies, new product packaging of pharmaceutical products from a
announcements and trends and visions of the single source.
manufacturing future presented by industry
leaders. Benefit from this international network- Additionally, our customers profit from our
ing event and meet top executives of the international network of excellent partners.
pharmaceutical and biopharmaceutical indus- We cooperate with leading software vendors like
tries and establish valuable contacts. SAP, Oracle, and OSIsoft as well as with dedicated
local endorsed service partners.

Benefits experienced by our customers

using PAS-X MES

100 % Paper management reduction

98 % Higher “Right First Time” factor
90 % Faster batch record generation
75 % Accelerated review times
60 % Shorter lead times
50 % Improved process analysis

Werum PAS-X MES 3

More than Save time
& effort and

software:
avoid risk.

Best practices
included!
With PAS-X, we provide a complete MES solution
including software, comprehensive services and
pre-configured content – for large multinational
as well as regional and mid-sized enterprises.

Vaccines
Fine
Devices
Bio Blood
Plasma Solids
Consumer
Chemicals Liquids OTC
Pharma
Cell & Gene Creams
Ointments

Product Life Cycle

Process Clinical Trial Commercial Packaging

Launch
Development Manufacturing Manufacturing Fill & Finish

PAS-X covers all key life cycle stages in pharma- It supports all major types of pharmaceutical
ceutical and biopharmaceutical manufacturing manufacturing, e.g. vaccines, biopharmaceuti-
comprising process development, commercial cals, solids, liquids and others.
bulk manufacturing and packaging.

4 Pharma Software
Software PAS-X Business Functions:
complete MES out of the box

PAS-X is a functionally complete MES product

enabling fast implementation. PAS-X provides Process
Development
Master Batch
Records Specification
out-of-the-box maximum standard functionality IMP
Manufacturing
for all applications in the pharmaceutical and
biopharmaceutical industries. The functional Finite
Scheduling
Weighing &
Dispensing
Electronic
Batch
Equipment
Management
Material
Flow &
Warehouse
Management Execution
architecture of PAS-X closely follows the ANSI/ Recording Inventory

ISA 95 standard.

Process
Quality
Track & Trace
Serialization Compliance
Control Aggregation

Manufacturing
Intelligence Performance

Content
In addition to our software product, we provide PAS-X Content Packages:
pre-configured MES Content Packages support- best practice industry templates save time
ing a jump-start to deploying PAS-X. Our GMP-
compliant content packages are unique: They
are based on the industry’s best practices con- Performance Quality
Manufacturing
firmed by our customers and they are influ- Intelligence
enced by the PFU, the largest pharma MES user
community worldwide. Our industry-specific Equipment Master Data Reports &
Labels
Rights &
Roles
Workflows
Administration
templates significantly save you time and effort.
When configuring PAS-X, your production site
no longer needs to start with an empty system. Cell & Gene API API Chemical Solid Dosage Fill & Finish Packaging
Process
Biotech indl. Sterile

Libraries

Equipment
Integration
Equipment
Supplier
LIMS
Integration Equipment
Specific
Libraries

Services PAS-X Service Packages:

accelerated MES implementation

With our comprehensive services we support

you during all PAS-X implementation phases – Strategic
Program
Principal
Consulting
Turnkey
we are recognized worldwide for our high level Management & Client
Advisory
of responsiveness. The PAS-X service portfolio
is based on the expectations of the PAS-X user Business System Business
Ready
community and on the best practices of the Assessment Architecture Process
Description

pharmaceutical and biopharmaceutical indus-

tries. You benefit from our outstanding pharma-
Fit Migration MBR Design
ceutical and biopharmaceutical MES expertise Verification Concept Fit
and highly specialized personnel avoiding
resource gaps when implementing MES.
Deployment Training Validation
Build

Go-Live Service Desk Change

Management
System
Supervision Run

Werum PAS-X MES 5

Software

The leading,
most functional
complete
MES product
PAS-X provides complete functionality
covering all your pharmaceutical and
biopharmaceutical manufacturing processes.

6 Pharma Software
MBR EBR W&D
Master Batch Records Electronic Batch Recording Weighing & Dispensing
PAS-X Master Batch Records allows Efficient electronic batch documen- The precise weighing and dispensing
you to easily set up and maintain tation is one of the most important of input materials based on recipe
libraries with standardized, reusable objectives in introducing an MES to specifications is the core of your
building blocks for MBR creation. the pharmaceutical and biopharma- pharmaceutical manufacturing
An easy-to-use graphical design tool ceutical production. With PAS-X processes. Accurate data collection
facilitates the MBR creation. PAS-X Electronic Batch Recording, all MBRs within this first processing step is
MBR simplifies workflows, shortening are electronically executed and the fundamental to batch tracking and
approval cycles and therefore drasti- processes and results are documen- documentation. In a reliable and
cally reducing associated documen- ted in compliance with the applicable easy-to-operate way, PAS-X Weighing
tation work. This function is also avail- statutory provisions. PAS-X EBR & Dispensing guides the user through
able as an entry-level solution, which ensures the error-free and guided the weighing process and provides
enables manufacturers to start with execution of the entire production the necessary support for compliance
a dedicated scope and scale up the process and right-first-time manu- with safety regulations and recipes. It
system later on a step by step basis facturing. supports manual as well as automated
to a complete MES system. weighing and dispensing operations.
Many customers start their electronic
manufacturing projects with the
W&D function and scale up according

“PAS-X will expedite the record

to their needs.

review process and reduce

error traps for our production.”
Production Supervisor
AstraZeneca

MFI EQM MI
Material Flow & Inventory Equipment Management Manufacturing Intelligence
PAS-X Material Flow & Inventory PAS-X Equipment Management PAS-X Manufacturing Intelligence helps
secures the in-plant material flow administers and monitors cleaning you to enhance the shop floor perfor-
throughout the entire pharmaceutical procedures and statuses for all types mance of your manufacturing pro-
manufacturing process. It comprises of production-related objects. This cesses. For instance, PAS-X KPI sup-
sub-functions for manual and auto­ includes MBRs and particular rules for ports operators, supervisors and
matic transport control as well as cleaning scales, work rooms, contai- production site managers to constantly
in-plant administration of shop floor ners, production equipment, set­up monitor operational performance data
storage areas. PAS-X MFI ensures that parts and toolkits. Even complex rules from the shop floor. This function is
the materials used in pharmaceutical for sterilization can be managed and also available as a lean standalone
production are uniquely identified on monitored. Electronic paperless equip- software solution for fast and easy
receipt by means of barcodes or ment logbooks document status lists, implementation. With PAS-X Data
transponders. Through its tracking cleaning rules and histories for indivi- Access you get curated data from your
function, PAS-X MFI supports uninter- dual container types. PAS-X MES that can be consumed and
rupted tracking of the entire material visualized without detailed PAS-X
flow and it provides details about knowledge. It provides full access to all
material quantities, available batches, data captured during electronic batch
batch qualities, and storage locations. recording, material flow control or
equipment management. Data from
external systems like LIMS, ERP and
Historian is also available.

Werum PAS-X MES 7

T&T
Level 4
Track & Trace Serialization
Aggregation
PAS-X Track & Trace enables you to Central
ERP System
comply with anti-counterfeiting Repository
requirements for medical drugs. It
provides serialization and aggregation SAP® Certified
out-of-the-box functionality for Level 3 Integration with
SAP Applications
packaging processes and integrates
the ERP and the Global Repository MES Solution
with the shop floor packaging equip- Packaging Solution
ment and line controllers (vendor-in- Track & Trace Solution, KPI Solution
dependent). PAS-X T&T is also available
as a standalone solution or as part of Level 0-2
the packaging solution seamlessly
integrated into packaging EBR.
PAS-X
Line Controller in Manual
Packaging

FISC WMS PQC

Finite Scheduling Warehouse Management Process Quality Control
PAS-X Finite Scheduling is covering PAS-X Warehouse Management PAS-X PQC ensures continuous
the whole production planning supports production-related monitoring of the production quality.
process and offers a tight integration warehouse logistics. The system It captures events and deviations
of scheduled activities with the actual components can be configured enabling you to drastically reduce
as-is status of the production within as required and form the basis for batch review and release times. In
PAS-X. The integrated solution delivers implementing warehouse mana- order to achieve the best possible
detailed scheduling of your production gement systems, control systems quality and to take preventive measu-
processes and resources with finite and picking systems. res, PAS-X PQC supports process-
capacity, the optimization of produc- analytical on-line, in-line, and at-line
tion sequences, multi-scenario ana- quality control. The function allows the
lyses, and the management of implementation of Process Analytical
materials and teams. Technology (PAT) as well as Review by
Exception and state-of-the-art Quality
by Design (QbD) concepts.

“Werum’s PAS-X MES shows great promise

to help improve quality in a number of areas.
These include operator sign off
within batch records, release without exception
and improved deviation tracking.”
David Smith, Head of Innovation and Engineering
Hitachi Chemical Advanced Therapeutics Solutions, LLC

8 Pharma Software
Easy to start:
start small and
scale up later
Our entry-level solutions allow you to gradually
implement different parts of our MES
solution – an appealing option especially for
regional and mid-sized pharmaceutical and
biopharmaceutical enterprises.

ions
nct
l fu
ona
diti
h ad
p wit
le u
Sc a
Specific MES function Complete
e.g. Weighing & Dispensing MES functionality

Scalable entry-level solutions

The entry-level solutions focus on specific business Entry-level solutions:
processes and their functionality covers a dedicated scope
of related tasks. Later, you can expand your entry-level • Weighing & Dispensing
solution by adding new business functions to a functionally • Master Batch Records
complete PAS-X MES. Each acquired module builds on and • Packaging
complements the previous modules. This approach • Track & Trace
provides you with just the functionality you require and
• KPI / OEE
ensures a maximum security of your investment.

Werum PAS-X MES 9

Content

Best-practice
content for fast
MES deployments
Our pre-configured PAS-X Content Packages
allow a jump-start to deploying PAS-X MES.
Based on the industry best practice and the
knowledge of our consultants, they reflect the
requirements of the PAS-X users.

Manufacturing Administration
Intelligence The “PAS-X Equipment” Content Package
delivers a best practice guideline of how to
Industry-specific PAS-X as a batch recording system collects data design and document equipment status
templates
from various sources into the batch record. diagrams. It shows the dependencies and
Using PAS-X Content
Packages, projects The “PAS-X Performance” and “PAS-X Quality” functionalities of the different states, activities
have an excellent
Content Packages offer pre-configured evalua- and their respective semantics. Additionally, the
starting point
to quickly create the tion templates for different areas such as per- package contains ready-to-use best practice
final parameteriza-
formance data and quality data along with the status diagrams e.g. for cleaning, assembly,
tion of your PAS-X MES
system. associated consulting services and a state-of- sterilization, reusables etc.
the-art tools for data evaluation. The evaluation
templates comprise dashboards, production The “PAS-X Master Data” Content Package
monitoring and process optimization to make details relevant master data for PAS-X required
this data available, easily accessible and to use the MES system. The step-by-step para-
convenient to visualize. This will enable visibility meterization guideline explains details regarding
in manufacturing. Typical production questions the master data and takes into account the
such as trends for yield, exceptions, deviations sequence of creating master data and high-
and review times (time to market) are answered lighting dependencies between them. Once
in a smooth way. all chapters of the content package were
considered, a functional PAS-X system becomes
available that can be used to create MBRs,
execute orders and produce materials.

10 Pharma Software
Fast MES setup
The content packages
The „PAS-X Reports & Labels“ Content Package Equipment Libraries
offers pre-configured reports (MBR reports,
can be used to pre-
pare PAS-X systems for batch reports, etc.) and labels along with the The “PAS-X Equipment Integration” Content
different industry
associated comprehensive consulting services. Package offers best practice guidelines on how
segments.
The package comprises GMP-compliant to integrate equipment with PAS-X. Additionally,
templates for reports and labels which are the package contains ready-to-use best practice
specifically tailored to manufacturing state machines and MBR design elements for
technologies such as solid dosage and equipment integration. MBR designers can save
biopharmaceutical API production. up to 80 % of the time usually required for initial
MBR creation considering equipment integration.
The “PAS-X Rights & Roles” Content Package
supports the parameterization of PAS-X user The “PAS-X Equipment Supplier Specific”
rights based on global, GMP-compliant profiles Content Packages accelerate the creation of
and specific roles such as Operator, Supervisor MBRs and help to assure high quality MBR design.
and QA/QM personnel. It considerably simplifies They contain templates with MBR design
the configuration and maintenance of the highly elements to create MBRs for the integration of
flexible user rights capability of PAS-X. System specific pharmaceutical and biopharmaceutical
administrators can save up to 95 % of the time equipment such as granulators, tablet presses or
usually required for the initial configuration and packaging lines.
testing of rights.
The “PAS-X LIMS Integration” Content Package
The “PAS-X Workflows” Content Package provides several best practice MBR workflows
delivers workflows for reviewing and releasing, for the integration of data exchange between
e.g. MBRs and BRRs. The packages are LIMS or similar systems and PAS-X EBR. These
preconfigured based on industry best practices workflows are provided as library templates
and can be adapted in a flexible fashion. System which use preconfigured, ready-to-use message
administrators are enabled to manage PAS-X schemes as basis for the communication.
workflows in a self-dependent manner.

Process Libraries Why PAS-X Content

The “PAS-X Process Libraries” Content • Easy and fast setup
Packages accelerate the development of MBRs of PAS-X MES
and help to assure high quality MBR design based • Industry best practice
on the industry best practices and considering based configuration
data integrity, lean BRRs and process
• GMP compliance
harmonization. MBR designers can save up to
• Specified content for
80 % of the time usually required for initial MBR
pharmaceutical and
creation. The packages provide templates with
MBR design elements to create MBRs for specific
biopharmaceutical
pharma and biotech processes such as manufacturing
granulation, IPC testing or reconciliation. They • Accelerated MBR creation
are available for all major manufacturing • Process harmonization
technologies, such as cell and gene therapy, API
biotech, solid dosage and packaging.

Performance Quality
Manufacturing
Intelligence

Equipment Master Data Reports &

Labels
Rights &
Roles
Workflows
Administration

PAS-X Content
Packages Cell & Gene API API Chemical Solid Dosage Fill & Finish Packaging
Process
Best practice industry Biotech indl. Sterile

templates to save you Libraries

time.

Equipment Equipment LIMS

Integration Supplier Integration Equipment
Specific
Libraries

Werum PAS-X MES 11

Services

Speed up
deployment!
Our unique implementation methodology
allows a fast MES implementation at
pharmaceutical and biopharmaceutical
production sites.

Industry Customer Site GO

READY FIT BUILD RUN
Template Template System LIVE

Rapid deployment through standards

Ready Fit Build Run

Prior to the start of an MES In the Fit Phase, the In the Build Phase, the Once the system is
project – in the customer-specific system is configured operational, we support
Ready Phase – we offer business processes are or enhanced, for example you in the Run Phase with
consulting services mapped to the with interfaces, and our qualified service desk
to ensure process PAS-X software product. it is implemented and team and with maintenance
understanding and the The PAS-X system qualified at your plant. agreements that ensure
organizational readiness is configured and the protection of your
of your site. parameterized according investment with an upgrade
to the business processes guarantee.
and production recipes.

12 Pharma Software
Lean MBRs High-quality MBRs with “Design as a Service”
We offer MBR
With our unique “Design as a Service” offering we
development services
and process con- provide a complete solution for the cost-effective Ensuring the success
sultation to design,
create and verify
creation of lean, high-quality and streamlined of your MES project
high-quality MBRs for MBRs. The packages comprise pre-configured
you.
industry-specific content based on best prac-
• “Design as a service”
tices, ready-to-use concepts and guidelines for
MBR development
the efficient creation and optimization of MBRs
• Local PAS-X training courses
and profound, first-hand PAS-X knowledge direc-
tly from the MES supplier. The resulting MBRs are
• Highly qualified consultants
lean, efficient and optimized to meet your require- • Qualified service desk 24 / 7
ments in regard to “Review by Exception”. • Self-Service Portal

Pharma software academy: well-trained and Consulting: Our experts take care solely about
qualified PAS-X users your industry
Only well-trained personnel ensures the success To ensure the most effective management
of your PAS-X MES project – we deliver the of your PAS-X MES implementation project, we
relevant out-of-the-box PAS-X training tracks. offer a comprehensive set of consulting services
Our PAS-X training courses are composed of and a dedicated team of consultants with the
standardized modules that can be selected and skill and expertise to design and create MBRs
organized flexibly to cover all PAS-X functiona- for various industries. Our consultants are in
lities. We will be happy to hold your PAS-X training personal and direct contact to our PAS-X product
courses locally at your plant and on your date of development teams and well-trained in operating
preference. Apart from this, we regularly offer PAS-X MES. They are excellent experts for all
training courses at our modern premises in our major pharmaceutical manufacturing tech-
headquarters in Lüneburg, Germany, or at one of nologies like solid production, packaging,
our international locations. biopharmaceutical and chemical API production.
With this wide set of skills, our consultants are
able to advise our customers in using PAS-X MES
functionality and creating MBRs to support their
business processes in the best possible way.

Cost-effective creation of high-quality MBRs Self-Service Portal & excellent local support
and services
As a customer you get access to our digital
Inside PAS-X Knowledge
Self-Service Portal with know-how databases,
Concepts & Guidelines
FAQs, current product information and other
Industry Best Practices
helpful services. If you prefer personal support
Content Packages
you benefit from our worldwide 24 / 7 / 365
support team with short solution times. Our
team members are highly qualified experts with
MBR MBR MBR
Design Creation Varification Lean long-time experience. Local support during
MBRs
operation at your site is guaranteed by our
subsidiaries and endorsed service partners. Our
Design as a service – partners are obliged to fulfill all the require-
more than MBR Factory ments of the PAS-X service partner program.

MBR
MBRs
Factory

MBR Factory

Werum PAS-X MES 13

Good reasons
to decide for
PAS-X
2020
Best Bio-
processing
Software
2016 Award 2019
Asian Frost & Sullivan
Manufacturing Global Technology
Award Leadership Award

2019
2017
Best Bio-
Frost & Sullivan
Global Technology PAS-X MES processing
Leadership Award awarded Software
manufacturing Award
software

2017 2018
Asian APAC CIO
Manufacturing Outlook
Award Award
2018
Industriepreis
2018 - Best Of

PAS-X speeds up PAS-X enables PAS-X boosts PAS-X improves PAS-X safeguards
time-to-market digitization efficiency quality compliance

save time save effort avoid risk

14 Pharma Software
 We have you
covered, always
and everywhere
With local pharma software experts around the
world we support you wherever your business
is located.

Dublin, Ireland Lüneburg, Germany, Global HQ

St. Augustin, Germany Karlsruhe + Hausach, Germany
Parsippany, NJ, USA, Vienna, Austria
Lyon, France
North America HQ Toulouse, France Budapest, Hungary
Tokyo, Japan
Los Angeles, CA, USA
Cary, NC, USA Shanghai, China

Mumbai, India
Pune, India Bangkok, Thailand,
Asia Pacific HQ
Bengaluru, India

Singapore, Asia

São Paulo, Brazil,

Latin America HQ

Delivering the difference in pharma At the Körber Business Area Pharma we are
delivering the difference along the pharma value
We are Körber – an international technology chain with our unique portfolio of integrated
group with about 10,000 employees, more than solutions. With our software solutions we help drug
100 locations worldwide and a common goal: manufacturers to digitize their pharma, biotech
We turn entrepreneurial thinking into customer and cell & gene factories. The software product
success and shape the technological change. In Werum PAS-X MES is recognized as the world’s
the Business Areas Digital, Pharma, Supply Chain, leading Manufacturing Execution System for the
Tissue and Tobacco, we offer products, solutions pharma & biotech industry. Our data analytics and
and services that inspire. AI solutions accelerate product commercialization
and uncover hidden business value.

Werum PAS-X MES 15

 Subject to alterations Copyright © 08.2020 Werum IT Solutions GmbH

Werum IT Solutions Ltd., Thailand (Asia Pacific HQ)

Liberty Square Building, 14th FL.
Unit 1405, 287 Silom Rd.
Silom, Bangrak, Bangkok 10500, Thailand
T +66 2 0205720
[email protected]
koerber-pharma.com