White Paper – Pharma Software

5 benefits of
using an MES
for pharma
and biotech
How to save time and effort
and avoid risk
What is an MES
for pharma and biotech?
Manufacturing Execution Systems (MES) are IT systems
that enable digital manufacturing and an integrated
management and control of manufacturing processes in
a factory. They ensure the control of various elements
of the production process such as materials, machines,
and equipment.
While Enterprise Resource Planning (ERP) solutions aim to
support enterprise-wide collaboration with a focus on
office-based functions (finance, procurement, HR, supply
chain, etc.), MES solutions allow planning and control of
factory shop floor operations.
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They thus complement the ERP level with more process-
related functions, act as the central connecting platform
between ERP and process control systems (SCADA, DCS)
and may also provide real-time manufacturing data from
shop floor machines and sytems for higher-level planning.
MES in pharma and biotech introduce electronic batch
recording to the pharmaceutical production. They take care
of batch execution and GMP-compliant documentation of
every process step.
Why MES?
The short answer is: Manufacturing Execution
Systems offer substantial improvements over
paper-based processes.

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

MES help pharma manufacturers create flawless manu- In addition, they provide valuable real-time information
facturing processes, reduce risks, time, costs and effort, on requirement changes. And they are an important pre-
and increase process efficiency and product quality. requisite for digitization and Pharma 4.0.

5 benefits of using an MES 3

The benefits for
pharma & biotech
companies
The more detailed answer takes into
account five key areas where pharmaceutical
and biotech companies can benefit from
using an MES.
Benefit 1
MES speeds-up
time-to-market
Although MES focuses mainly on
production, it can even shorten
time-to-market. An MES designed
specifically for pharmaceutical and
biopharma manufacturers, such
as PAS-X from Werum IT Solutions,
transfers products and recipes from
late clinical trial manufacturing to
launch and commercial manufactur-
ing. It allows the development of
high-quality Master Batch Records
at an early stage leveraging the use
of standardized libraries and best
practice industry design. Pharma
MES thus provide capabilities to
speed up the modeling of manufac-
turing processes ensuring easy
scale-up and faster time-to-market.
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Benefit 2
MES enables
digitization
An MES eliminates paper and digitizes
processes in the factory. In paper-
based processes, human errors are
unavoidable, as are delays due to
suboptimal and slow information
flows. Digital processes are faster,
less error-prone and can be controlled
much more effectively. Moreover, they
are the basis for process automation
and for Pharma 4.0 which relies on
flexible production-support systems
at the manufacturing level to meet
increasingly individual and complex
market requirements. So, MES solu-
tions can be leveraged for innovation,
future-oriented processes and higher
competitiveness.
Benefit 3
MES boosts
manufacturing
efficiency
Because MES simplifies quality assur-
ance, it also helps to make processes
more efficient: The “Right First Time”
factor increases, batch review and
lead times become shorter. In paper-
based manufacturing, QA needs
several hours or even more to review
batch records. In digitized production,
QA can review batch records parallel
to production, is alerted by the MES to
critical parameters and exceptions,
and can release a batch within a few
minutes. Digitized processes can be
automated easily, and real-time
manufacturing data help optimizing
processes and increase equipment
efficiency. The Total Cost of Owner-
ship (TCO) of a modern MES enables a
fast Return on Investment (ROI).

Benefit 4
MES improves
quality
The right MES can significantly im-
prove product and process quality in
pharmaceutical production. In manual,
paper-based recordings of production
processes, up to 20 percent of batch
deviations are caused by human
error. An MES guides the operator
through all production processes.
It can greatly reduce these human
errors, implement proven best
practices, and provide the transpar-
ency needed for data-based analysis
of quality-critical processes.
5 benefits of using an MES
Benefit 5
MES safeguards
regulatory
compliance
The right MES can support compliance
and reduce risks in three crucial areas:
compliant processes, data integrity,
and sufficient documentation.
A proper MES guides the user in the
pharma factory electronically through
the entire manufacturing process,
from weighing and dispensing to
batch production and packaging.
For example, the system prompts the
operator to follow certain steps, e. g.
scan bar codes of raw materials, or
perform point of use checks. It also
prevents usage of unusable equip-
ment or material. An MES enables right
first time, detects deviations and
initiates measures in real time rather
than detecting deviations in the batch
record review.
How to find
the right
MES provider
With the right MES, pharma-
ceutical and biotech manufac-
turers can reduce time, efforts
and risks and finally save costs
– provided that the system
meets the requirements of the
pharmaceutical industry in
terms of functions, usability
and compliance. To ensure
this, it is essential that the
MES provider understands the
industry-specific products and
shop-floor processes and also
has the necessary experience
to implement such systems
successfully.
This way an MES can help to ensure
compliance with FDA and cGMP
quality assurance guidelines – provid-
ed the system fulfills the functional
requirements of pharma and biotech
production according to the ANSI/ISA
95 standard and supports the relevant
types of pharmaceutical manufactur-
ing such as vaccines, biopharmaceuti-
cals, solids or liquids.
The MES also provides product track-
ing capabilities and full digital docu-
mentation of actions and of the
material use at each destination,
enabling full transparency. As a matter
of course, companies need to make
sure that their MES supports data
integrity requirements put forward
by regulatory bodies such as the FDA,
EMA, CFDA and WHO.
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more than 100 locations worldwide and a common goal: We turn entrepreneurial
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Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer
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At the Körber Business Area Pharma we are delivering the difference along the
pharma value chain with our unique portfolio of integrated solutions. With our
software solutions we help drug manufacturers to digitize their pharma,
biotech and cell & gene factories. The software product Werum PAS-X MES is
recognized as the world’s leading Manufacturing Execution System for
the pharma & biotech industry. Our data analytics and AI solutions accelerate
product commercialization and uncover hidden business value.

Werum IT Solutions GmbH (Global HQ)

Wulf-Werum-Str. 3
21337 Lüneburg, Germany
T +49 4131 8900-0
info.pasx@koerber-pharma.com
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