Werum IT Solutions Award Write Up

2017 Global Industrial Automation Solutions for Pharma & Biotech Technology Leadership Award

BEST PRACTICES RESEARCH

© Frost & Sullivan 2017 2 “We Accelerate Growth”

Contents

Background and Company Performance ........................................................................ 3

Industry Challenges .............................................................................................. 3

Technology Leverage and Business Impact .............................................................. 4

Conclusion........................................................................................................... 7

Significance of Technology Leadership .......................................................................... 8

Understanding Technology Leadership .......................................................................... 8

Key Benchmarking Criteria .................................................................................... 9

Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best Practices ................................................................................................................. 10

The Intersection between 360-Degree Research and Best Practices Awards ..................... 11

Research Methodology ........................................................................................ 11

About Frost & Sullivan .............................................................................................. 11



Background and Company Performance

Industry Challenges

A manufacturing execution system (MES) is a production scheduling and tracking system

for analyzing and reporting resource availability and status; scheduling and updating

manufacturing orders; collecting detailed execution data (e.g., material or labor usage,

process parameters, equipment status, events and deviations) and other critical

information. MES provides the real-time shop floor reporting and monitoring that feeds

activity data back to the base system.1 Product segmentation in the MES market consists

of software that has all functionalities and features which are implemented to manage

daily operations in the manufacturing environment - as well as services that include

implementation, maintenance, software updates, consulting, and after-sales assistance.

Today, Frost & Sullivan monitors how the advent of industrial mobility, cloud computing,

and Big Data processing significantly impact the MES solutions market, further

transforming the entire industrial manufacturing value chain. The global MES market

generated revenue of $4.6 billion in 2013; Frost & Sullivan expects this market to grow at

a compound annual growth rate (CAGR) of 9.5% from 2013 to 2020.2

Pharmaceutical and biotechnology (biotech) companies also widely adopt MES solutions.

Interested vendors include the manufacturers of biological and medicinal products or

botanical drugs, and herbs, as well as the manufacturers of pharmaceutical products for

internal and external consumption in different forms (e.g., ampoules, tablets, capsules,

ointments, vials, powders, solutions, and suspensions). The biotechnology sector includes

companies involved with the use of biological systems, bio-organisms, and technology to

develop medicinal products. Frost & Sullivan research shows that these sectors face the

challenge of the need for advanced integration of MES solutions across different levels of

manufacturing processes with a growing demand for system operability in the production

environment.

Frost & Sullivan independent analysis

reveals that another challenge for MES

providers for the mentioned sectors is

the decreasing profits in the

pharmaceutical industry. The

pharmaceutical and biotech industry

faced a large number of patent losses in

recent years, which created intense

competition from generic drug

manufacturers and eroded profit

margins. As a result, the automation

investment in existing production

facilities remains low. As such, the need

for cost-effective automation processes is gaining importance to optimize production.

1 See, Frost & Sullivan, Strategic Analysis of the Global MES Market 2 See, Frost & Sullivan, Strategic Analysis of the Global MES Market

Source: Frost &

Sullivan



Another challenge and driving factor for the adoption of industrial automation, particularly

MES solutions, is the constant regulatory change ensuring quality and safety in all

manufacturing processes. Regulatory agencies, such as the Food and Drug Administration

(FDA) and the European Medicines Agency (EMA) constantly monitor the pharmaceutical

and biotech industries. The FDA requires manufacturers to provide greater transparency

through audit trails and access control functions. To meet these requirements,

manufacturers are adopting electronic validation and batch recording. Frost & Sullivan

points out that MES allows global integration across the value chain, thus enabling the

tracking of material and product flow in compliance with FDA requirements for traceability.

Frost & Sullivan independent research expects the MES market for pharmaceuticals and

biotechnology sector will reach of $1.3 billion in 2019 and will grow at CAGR of 15.1% up

to 2019.3

Technology Leverage and Business Impact

Leading the Way in MES Solutions for the Pharmaceutical and Biopharmaceutical

Industries

Founded in 1969 and headquartered in Lueneburg, Germany, Werum IT Solutions is the

world’s leading supplier of the MES and manufacturing IT solutions dedicated to the

pharmaceutical and biopharmaceutical industries.

Werum’s engineering of IT solutions helps pharmaceutical and biotechnology

manufacturers to improve the operational efficiency of their businesses while increasing

productivity and meeting regulatory requirements.

To resourcefully serve the highly competitive and specific pharmaceutical market, Werum

provides a complete MES solution consisting of the PAS-X software, pre-configured

content, and a comprehensive set of services. Werum’s trinity (software, content, and

services) always comes together to create the greatest value for customers. PAS-X

software integrates all related IT and production systems such as ERP, LIMS, or DCS

through standardized interfaces, thus providing seamless information exchange, data

integrity and higher performance. The content derives from Werum’s best practices

knowledge on the industry operation; e.g., the company can provide all of the templates

specifically designed for different pharmaceutical manufacturing technologies.

Werum’s solutions cover the entire value chain - from the earliest stages of process

development, clinical trial stages to full-steam commercial manufacturing and final

packaging. The company also works on enterprise manufacturing intelligence and

advanced integration of the automation layer while offering advanced interfacing

technologies as a response to the Internet of Things (IoT, Industrie 4.0) trend.

3 See, Frost & Sullivan, Global Automation and Control System Market in the Pharmaceutical

and Biotech Industry



Best-in-Class PAS-X Software

Werum’s software is based on decades of successful MES implementation projects and

reflects the industry best practices that make the PAS-X fit approximately 90% of any

customer’s needs from the beginning of the operation. Pre-configured templates facilitate

the deployment of the PAS-X MES with unprecedented speed and efficiency.

PAS-X is Werum’s flagship product, excelling with a full-scope functionality that is simple

to operate. Werum covers all of the needs of pharmaceutical and biotechnology

manufacturing while ensuring the functional completeness of its solution. PAS-X consists

of core MES functionalities, such as

PAS-X Master Batch Records, which allows to easily set up and maintain libraries with

standardized, reusable building blocks for MBR creation,

PAS-X Electronic Batch Recording, which ensures the error-free and guided execution of

the entire production process and right-first-time manufacturing,

PAS-X Weighing & Dispensing, that guides the user through the weighing processes and

provides efficient support for compliance with safety regulations and recipes.

PAS-X Material Flow & Inventory, which secures in-plant material, flow throughout the

whole manufacturing process,

PAS-X Equipment Management that administers and monitors cleaning procedures and

statuses for all types of production-related objects.

PAS-X Process Quality Control, which captures events and deviations enabling companies

to drastically reduce batch review and release time and to implement Review by Exception

Furthermore, PAS-X provides additional functionalities, such as PAS-X Manufacturing

Intelligence that helps enhance the shop floor performance within the manufacturing

processes; e.g. the PAS-X KPI Solution supports operators, supervisors and production

site managers to constantly monitor operational performance data from the shop floor.

More PAS-X functionalities are PAS-X Track & Trace that helps the pharmaceutical industry

to comply with anti-counterfeiting requirements, PAS-X Process Development, PAS-X

Warehouse Management and PAS-X Finite Scheduling.



PAS-X Master Batch Records

PAS-X KPI Operator Dashboard

A recent example of PAS-X recognition among pharmaceutical manufacturers was the fact

that Polpharma — the largest Polish manufacturer of pharmaceuticals that ranks in the top

20 generic drug manufacturers worldwide — introduced Werum’s MES solution in its

production facility in Starogard Gdański, Poland. This implementation helps Polpharma’s

products comply with actual regulations and improve the overall process quality.

Partnership with Customers as Key for Future Growth

Leveraging over 25 years of deep focus on MES market as well as strong relations with

customers, Werum IT Solutions runs its PAS-X User Forum which formulates and

prioritizes new requests and suggestions for further boosting the PAS-X functionality

(functional improvements) and strengthening Werum’s services and procedures (process

improvements). The PAS-X User Forum attaches great importance to a close cooperation

with other PAS-X clients and Werum and focuses on sharing experience and best practice

aspects. In addition the annual PAS-X User Group Meetings in Europe and America bring

together a global network of pharmaceutical and biopharmaceutical professionals, making

it the largest event in the pharmaceutical MES community. It also acts as an efficient

platform on a global basis for best practices exchange and discussion on the actual

industry challenges.

Source: Werum IT Solutions

PAS-X Weighing & Dispensing



Frost & Sullivan recognizes how Werum IT Solutions brings clear value for customers while

acting as an expert in the MES space. The Werum consultant team unites experienced IT

staff along with experts in pharmacy, biotechnology, and chemistry. Werum’s consultants

bring the valuable support on MES configuration and optimization of customers’ business

processes. As a result, today Werum IT Solutions delivers the market leading MES for the

pharmceutical and biopharmaceutical industries. It’s PAS-X software is run by the

majority of the world’s top 30 pharmaceutical and biotechnology companies as well as

many regional and mid-sized manufacturers - while providing local support to customers

during all MES implementation phases.

Werum IT Solutions understands the strategic importance of being perceived as a market

leader and expert. While running successful projects for leading global companies in

Europe, Asia, and North and South America, Werum plans to remain a technology leader,

take part in the latest regulatory discussions, and actively develop under the Internet of

Things/Industrie 4.0 concept.

Conclusion

The growing demand to replicate manufacturing plants and facilities and the requirements

to minimize costs associated with the downtime of production operations led end-users to

look for cost-effective, off-the-shelf manufacturing execution systems (MES) to face

complex environments and increase overall production efficiency, productivity, and

visibility. Responding to daunting technology challenges such as cloud, industrial mobility,

and Big Data analytics, Werum IT Solutions provides its unique PAS-X MES solution, the

most functional complete MES in the market, enabling efficient manufacturing operation -

especially critical within the pharmaceutical and biotechnology sectors.

With its leading technology system solutions and positive business impact of reducing

inefficiencies and increasing overall productivity and quality, Werum IT Solutions earns the

2017 Frost & Sullivan Technology Leadership Award.



Significance of Technology Leadership

Technology-rich companies with strong commercialization strategies benefit from the

increased demand for high-quality, technologically-innovative products. Those products

help shape the brand, leading to a strong, differentiated market position.

Understanding Technology Leadership

Technology Leadership recognizes companies that lead the development and successful

introduction of high-tech solutions to customers’ most pressing needs, altering the

industry or business landscape in the process. These companies shape the future of

technology and its uses. Ultimately, success is measured by the degree to which a

technology is leveraged and the impact that technology has on growing the business.



Key Benchmarking Criteria

For the Technology Leadership Award, Frost & Sullivan analysts independently evaluated

two key factors—Technology Leverage and Business Impact—according to the criteria

identified below.

Technology Leverage

Criterion 1: Commitment to Innovation

Criterion 2: Commitment to Creativity

Criterion 3: Technology Incubation

Criterion 4: Commercialization Success

Criterion 5: Application Diversity

Business Impact

Criterion 1: Financial Performance

Criterion 2: Customer Acquisition

Criterion 3: Operational Efficiency

Criterion 4: Growth Potential

Criterion 5: Human Capital



Best Practices Recognition: 10 Steps to Researching,

Identifying, and Recognizing Best Practices

Frost & Sullivan Awards follow a 10-step process to evaluate Award candidates and assess

their fit with select best practice criteria. The reputation and integrity of the Awards are

based on close adherence to this process.

STEP OBJECTIVE KEY ACTIVITIES OUTPUT

1 Monitor, target, and screen

Identify Award recipient candidates from around the globe

Conduct in-depth industry research

Identify emerging sectors

Scan multiple geographies

Pipeline of candidates who potentially meet all best-practice criteria

2 Perform 360-degree research

Perform comprehensive, 360-degree research on all candidates in the pipeline

Interview thought leaders and industry practitioners

Assess candidates’ fit with best-practice criteria

Rank all candidates

Matrix positioning of all candidates’ performance relative to one another

3

Invite thought leadership in best practices

Perform in-depth examination of all candidates

Confirm best-practice criteria Examine eligibility of all

candidates Identify any information gaps

Detailed profiles of all ranked candidates

4

Initiate research director review

Conduct an unbiased evaluation of all candidate profiles

Brainstorm ranking options Invite multiple perspectives

on candidates’ performance Update candidate profiles

Final prioritization of all eligible candidates and companion best-practice positioning paper

5

Assemble panel of industry experts

Present findings to an expert panel of industry thought leaders

Share findings Strengthen cases for

candidate eligibility Prioritize candidates

Refined list of prioritized Award candidates

6

Conduct global industry review

Build consensus on Award candidates’ eligibility

Hold global team meeting to review all candidates

Pressure-test fit with criteria Confirm inclusion of all

eligible candidates

Final list of eligible Award candidates, representing success stories worldwide

7 Perform quality check

Develop official Award consideration materials

Perform final performance benchmarking activities

Write nominations Perform quality review

High-quality, accurate, and creative presentation of nominees’ successes

8

Reconnect with panel of industry experts

Finalize the selection of the best-practice Award recipient

Review analysis with panel Build consensus Select recipient

Decision on which company performs best against all best-practice criteria

9 Communicate recognition

Inform Award recipient of Award recognition

Present Award to the CEO Inspire the organization for

continued success Celebrate the recipient’s

performance

Announcement of Award and plan for how recipient can use the Award to enhance the brand

10 Take strategic action

Upon licensing, company is able to share Award news with stakeholders and customers

Coordinate media outreach Design a marketing plan Assess Award’s role in future

strategic planning

Widespread awareness of recipient’s Award status among investors, media personnel, and employees



The Intersection between 360-Degree Research and Best Practices Awards

Research Methodology

Frost & Sullivan’s 360-degree research

methodology represents the analytical

rigor of our research process. It offers a

360-degree-view of industry challenges,

trends, and issues by integrating all 7 of

Frost & Sullivan's research methodologies.

Too often companies make important

growth decisions based on a narrow

understanding of their environment,

leading to errors of both omission and

commission. Successful growth strategies

are founded on a thorough understanding

of market, technical, economic, financial,

customer, best practices, and demographic

analyses. The integration of these research

disciplines into the 360-degree research

methodology provides an evaluation

platform for benchmarking industry

players and for identifying those performing at best-in-class levels.

About Frost & Sullivan

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please visit http://www.frost.com.

360-DEGREE RESEARCH: SEEING ORDER IN

THE CHAOS

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