Werum BR Pas-X Us
Werum BR Pas-X Us
Werum BR Pas-X Us
100 % FOCUS
ON PHARMACEUTICAL AND
BIOPHARMACEUTICAL INDUSTRIES
Werum IT Solutions is the globally leading supplier of manufacturing execution systems (MES)
and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. The
core of our offering is the PAS-X MES solution that combines software, content and services out
of the box.
PAS-X is run by the majority of the world’s top 30 phar- Supporting data integrity
maceutical and biopharmaceutical companies and by many PAS-X supports data integrity requirements put forward by
regional and mid-sized enterprises around the globe. With regulatory bodies such as the FDA, EMA, CFDA and WHO
PAS-X, we provide the leading MES product for pharmaceu- through:
tical and biopharmaceutical manufacturing – enabling a fast
implementation and providing complete out-of-the box func- 99 Best-practice business process harmonization per
tionality tailored to industry-specific needs. product and across sites
99 Accurate data capturing and control strategy
Werum is headquartered in Lüneburg, Germany, and has execution
many locations in Europe, North and South America and Asia 99 ALCOA implemented for raw data, meta data and
Pacific. true copies for data retention
99 Secure data access and system-controlled data review
In line with regulatory requirements
PAS-X meets all requirements set forth by the approving au-
thorities for operating computer systems in regulated indus-
tries. This includes the EU GMP guidelines, the GMP Annex
11 for Computerized Systems Guidelines and the FDA guide-
lines 21 CFR Part 11 and 21 CFR Part 210/211.
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Large multinationals as well as regional and
mid-sized enterprises benefit from PAS-X MES
Among our references are many of the largest and most It is an important sign of our strength and capability that not
demanding pharmaceutical manufacturers worldwide who only large multinationals are gaining the benefits of the PAS-X
deployed PAS-X as their standard MES in large installations MES but that we have also implemented many successful
and on a global scale and therefore cooperate with us on a solutions for leading regional and mid-sized enterprises in
strategic basis. The majority of the top 30 companies se- Europe, North and Latin America and Asia Pacific.
lected PAS-X to improve their production performance and
compliance.
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.
PAS-X covers all key life cycle stages in pharmaceutical and It supports all major types of pharmaceutical manufacturing,
biopharmaceutical manufacturing comprising process deve- e.g. vaccines, biopharmaceuticals, solids, liquids and others.
lopment, commercial bulk manufacturing and packaging.
Solids
Fine OTC
Bio Vaccines
Blood Consumer
Chemicals
Devices
Plasma Liquids
Pharma
Creams Ointments
PRODUCT LIFE CYCLE
PAS-X covers all key life cycle stages and all major types of pharmaceutical manufacturing
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SOFTWARE
CONTENT
SERVICES
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PAS-X: THE MARKET-LEADING PHARMA MES
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WEIGHING & DISPENSING (W&D)
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PAS-X: THE MARKET-LEADING PHARMA MES
PAS-X Warehouse Management supports production-re- PAS-X Finite Scheduling enables the detailed scheduling of
lated warehouse logistics. The system components can be production processes. Since it includes sub-functions for
configured as required and form the basis for implementing checking material availability and controlling order proces-
warehouse management systems, control systems and pi- sing, it is an ideal complement to the ERP system, adding
cking systems. specific shop floor scheduling functionality. PAS-X easily inte-
grates a great number of ERP systems thanks to its certified
standard interfaces.
PAS-X Process Quality Control ensures continuous monito- PAS-X Process Development / IMP Manufacturing simplifies
ring of the production quality. In order to achieve the best and speeds up the modeling of manufacturing processes for
possible quality and to take preventive measures, PAS-X pre-clinical and clinical production. It covers process deve-
PQC supports process-analytical on-line, in-line, and at-line lopment activities in all areas of the pharmaceutical and bio-
quality control. The function supports the implementation pharmaceutical industries including scale-up.
of Process Analytical Technology (PAT) and state-of-the-art We offer PD as an individual solution tailored to the specific
Quality by Design (QbD) concepts. Quality Control Dash- development processes of your company.
boards can be configured to show deviations in the different
manufacturing and packaging sectors.
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EASY AND FAST INTEGRATION OF RELATED IT SYSTEMS
The great number of PAS-X standard interfaces accelerates We use the interface definitions of international industry stan-
implementation projects and ensures seamless information dards (OPC, XML, etc.). PAS-X fully complies with the ANSI/
exchange with all surrounding IT systems. You benefit from ISA 95 and ANSI/ISA 88 standards regarding the functional
clearly defined PAS-X standard interfaces, through which assignment of tasks to different levels.
PAS-X is horizontally and vertically integrated into your IT in-
frastructure. Integrated IT systems are a prerequisite for be-
nefiting from production strategies such as Lean Production,
Standard
Six Sigma, Performance integration
Monitoring of PAS-X
or Right-First-Time.
SAP ® Certified
Integration with SAP Applications
LEVEL 4
ERP
Based on
ANSI/ISA 95 Standard
LIMS
LEVEL 3
LES CAPA
LDAP DMS
Based on
ANSI/ISA 88 Standard
LEVEL 0-2
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PAS-X: THE MARKET-LEADING PHARMA MES
Our pre-configured PAS-X Content Packages allow a jump-start to deploying PAS-X MES. They
are based on the best practices of the industry, the industry knowledge of our consultants and
reflect the requirements of the PAS-X user community. The content packages can be used to pre-
pare PAS-X systems for different industry segments.
PAS-X as a batch recording system collects data from va- production monitoring and process optimization to make this
rious sources into the batch record. The “PAS-X Perfor- data available, easily accessible and convenient to visualize.
mance” and “PAS-X Quality” Content Packages offer pre- This will enable visibility in manufacturing. Typical production
configured evaluation templates for different areas such as questions such as trends for yield, exceptions, deviations
performance data and quality data along with the associa- and review times (time to market) are answered in a smooth
ted consulting services and a state of the art tool for data way.
evaluation. The evaluation templates comprise dashboards,
ADMINISTRATION CONTENT
The “PAS-X Equipment” Content Package delivers a best sequence of creating master data and highlighting depen-
practice guideline of how to design and document equipment dencies between them. Once all chapters of the content pa-
status diagrams. It shows the dependencies and functiona- ckage were considered, a functional PAS-X system becomes
lities of the different states, activities and their respective available that can be used to create MBRs, execute orders
semantics. Additionally, the package contains ready-to-use and produce materials. Along with the “PAS-X Master Data”
best practice status diagrams e.g. for cleaning, assembly, Content Package comes a prebuilt Excel file to store and
sterilization, reusables etc. maintain master data and to document the system parame-
terization for validation purposes.
The “PAS-X Master Data” Content Package details rele-
vant master data for PAS-X required to use the PAS-X sys- The „PAS-X Reports & Labels“ Content Packages offer
tem. The step-by-step parameterization guideline explains pre-configured reports (MBR reports, batch reports, etc.)
details regarding the master data and takes into account the and labels along with the associated comprehensive consul-
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ting services. The packages comprise GMP-compliant tem-
plates for reports and labels which are specifically tailored to
manufacturing technologies such as solid dosage and bio-
pharmaceutical API production.
Using the PAS-X Content Packages contributes to accelera-
ting the PAS-X implementation. They are not only reducing
the initial effort to parameterize the MES system but also
have an impact on the revalidation of the system.
The “PAS-X Process Libraries” Content Packages accele- The “PAS-X Equipment Integration” Content Package of-
rate the development of MBRs and help to assure high quality fers best practice guidelines on how to integrate equipment
MBR design based on the industry best practices and con- with PAS-X. Additionally, the package contains ready-to-use
sidering data integrity, lean BRRs and process harmonizati- best practice state machines and MBR design elements for
on. They support standardization of production processes, equipment integration. The “PAS-X Equipment Integration”
process harmonization across sites and the development of libraries support standardization of equipment integration.
lean MBRs. MBR designers can save up to 80 % of the time MBR designers can save up to 80 % of the time usually re-
usually required for initial MBR creation. The packages provi- quired for initial MBR creation considering equipment integ-
de templates with MBR design elements to create MBRs for ration.
specific pharma and biotech processes such as granulation,
IPC testing or reconciliation. They are available for all ma- The “PAS-X Equipment Supplier Specific” Content Pa-
jor manufacturing technologies, such as API biotech, solid ckages accelerate the creation of MBRs and help to assure
dosage and packaging. high quality MBR design based on the industry best practi-
ces. They contain templates with MBR design elements to
create MBRs for the integration of specific pharmaceutical
and biopharmaceutical equipment such as granulators, tab-
let presses or packaging lines.
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PAS-X: THE MARKET-LEADING PHARMA MES
Ready: Prior to the start of an MES project – in the Ready Build: In the Build Phase, the system is configured or enhan-
Phase – we offer consulting services to ensure process un- ced, for example with interfaces, and it is implemented and
derstanding and the organizational readiness of your site. qualified at your plant.
Fit: In the Fit Phase, the customer-specific business proces- Run: Once the system is operational, we support you in the
ses are mapped to the PAS-X software product. The P AS-X Run Phase with our qualified service desk team and
system is configured and parameterized according to the with maintenance agreements that ensure the protection of
business processes and production recipes. your investment with an upgrade guarantee.
Werum
Customer Site GO
READY Industry FIT BUILD LIVE RUN
Template System
Template
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High-quality MBRs with Werum Academy:
“Design as a Service” Well-trained and qualified PAS-X users
With our unique “Design as a Service” offering we provide Only well-trained personnel ensures the success of your
a complete solution for the cost-effective creation of lean, PAS-X MES project – we deliver the relevant out-of-the-box
high-quality and streamlined MBRs. The packages compri- PAS-X training tracks. Our PAS-X training courses are com-
se pre-configured industry-specific content based on best posed of standardized modules that can be selected and
practices, ready-to-use concepts and guidelines for the ef- organized flexibly to cover all PAS-X functionalities. We
ficient creation and optimization of MBRs and profound, first- will be happy to hold your PAS-X training courses locally
hand PAS-X knowledge directly from the MES supplier. The at your plant and on your date of preference. Apart from
resulting MBRs are lean, efficient and optimized to meet your this, we regularly offer training courses at our modern pre-
requirements in regard to “Review by Exception”. mises in Werum’s headquarters in Lüneburg, Germany,
or at one of our international locations.
MBR DEVELOPMENT
WERUM’S
DESIGN AS A SERVICE Inside PAS-X Knowledge
Content Packages
MBR MBR MBR Lean
Design Creation Verification MBRs
MBR FACTORY
MBR
Factory MBRs
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PAS-X: THE MARKET-LEADING PHARMA MES
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.
tions
nal func
additio
with
e up
Scal
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5 KEY BENEFIT AREAS
100 % focused on
1. Pharma & Biotech
4. Rapid implementation
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Lüneburg, Germany
(Global HQ)
Bangkok, Thailand
(Asia Pacific HQ)
Singapore, Asia
IMPRINT: Werum IT Solutions GmbH (Global HQ) · Wulf-Werum-Str. 3 · 21337 Lüneburg · Germany
T +49 4131 8900-0 · F +49 4131 8900-200 · info@werum.com · www.werum.com
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Imprint: Werum IT Solutions GmbH · Wulf-Werum-Str. 3 · 21337 Lüneburg · Germany
Tel. +49 4131 8900-0 · Fax +49 4131 8900-20 · info@werum.com · www.werum.com