NEW WAY TO MANAGE YOUR PRODUCTION: MES SUPPORTS DATA INTEGRITY · NEW WAY TO MANAGE YOUR PRODUCTION: MES SUPPORTS DATA INTEGRITY . Werum IT Solutions – the leading MES supplier

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5-Jun-17 1 Werum presentation

NEW WAY TO MANAGE YOUR PRODUCTION: MES SUPPORTS DATA INTEGRITY

Werum IT Solutions – the leading MES supplier for the pharma & biotech industry



Werum IT Solutions Company Profile MES Introduction New Regulatory Focus Area: Data Integrity

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Werum: The leading MES for Pharma & Biotech


500+ MES Experts

14 Locations worldwide

Headquarters: Lüneburg, Germany

800+ PAS-X MES installations worldwide

17/30 17 of the world‘s

top 30 pharmaceutical companies use PAS-X

25+ Years of experience in the field of MES

for pharma & biotech


We are always available for our customers


Brazil

North Carolina

New Jersey California

China

Japan

Singapore

Thailand

Germany

Switzerland France

India


CUSTOMERS’ PROCESS REQUIREMENTS ARE OUR CORE BUSINESS


Bio Fine Chemicals

Devices

Blood Plasma

Vaccines OTC

Liqu

ids

Oin

tmen

ts Solids

Consumer Creams

Process Development

Clinical Trial Manufacturing Launch Commercial

Manufacturing Packaging Fill & Finish

Pharma


PAS-X Business Functions


Broad set of functions

Specialized on life science

GMP built-in

Fits all manufacturing processes


Start small and scale up later


► Specific MES functions e. g. Weighing & Dispensing

► Up to complete MES functionality


Adaptable to the needs of your site


Complete MES Out-Of-The-Box

80%

100%

60%

40%

20%

0%

1990 1995 2000 2005 2010 2015 2020

Functionally complete

+

Customization -

SOFTWARE


Graphical drag & drop workflows Process library concept & standard

recipes built in Low maintenance and management

efforts Drastically reduced number of recipes


Best in class: Master Batch Records SOFTWARE


Intuitive shop floor dialogs Strong user guidance for Right-

First-Time Integrated deviation management Process and completeness checks


Best in class: Shop Floor Execution SOFTWARE


Intuitive dialogs Easy operation with

minimum training Touchscreen


Best in class: Usability SOFTWARE



MES success requires more than software

We offer comprehensive packages for fast and efficient deployment

Software, Content and Services from a single supplier

With leading industry knowledge and best practice built in


All this yields 5 key benefits!


Safeguarding regulatory compliance

Leveraging technology for innovation

Increasing manufacturing performance

Higher quality products and processes

Accelerating time-to-market




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6 typical challenges for pharmaceutical production


(* example based on data from France)

(*) Source : LEEM & POLE PHARMA – Conference PPP April 2015

Satisfy worldwide

compliance requirements

Increase competitivenes

Improve production capacity

Innovate to better meet demand

Increase Quality, Efficiency,

Compliance

Be more attractive and efficient


PAS-X will help you to meet the challenges of the pharmaceutical production of tomorrow


(*) Source : LEEM & POLE PHARMA – Conference PPP April 2015

Best answer to

regulatory requirements

Strengthened performance

Increased production capacity

technological innovation

More Quality, Efficiency,

Compliance

Increased performance


The key is to replace the paper and integrate!


► Electronic recording and documentation of all production data ► Faster batch release thanks to review by exception ► Reduction of human error and risk


Benefits from a global study of a Werum customer


Reduction of defects (product quality) by 25% Reduction of manufacturing cycle time by 35% Reduction of data entry time by 80% Reduction of batch deviations by 80% Reduction of WIP “Work In Process” by 25% Reduction of paperwork between shifts by 60% Elimination of lost paperwork by 80%

This presentation highlights the compliance and efficiency benefits as studied by a Werum customer following their global PAS-X MES program, these figures match other customer findings and are used to calculate ROI for potential projects




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It is about full integration!


Leve

l 0…

2

ERP Systems

Leve

l 4

Field Level

Manufacturing Packaging

Electronic Batch

Recording Leve

l 3


Compliance as per Global Standards built in


21 CFR Part 11 (1) Inspection: Accurate reports and copies of ER 11.10 (b)

(2) Protection: Retrieval of electronic records 11.10 (c)

(3) Access and authority check 11.10 (d+g)

(4) Audit trail 11.10 (e)

(5) Operational checks: Sequencing of steps 11.10 (f)

(6) Control access and use of system operation docs 11.10 (ki+kii)

(7) Display signature and meaning 11.50 (a, aiii)

(8) Signature integrity 11.70

(9) Unique signature, non-biometric signature 11.100(a).200(a1)

(10) Maintain uniqueness of signature 11.300a


MES RECORDS DATA THE AUTHORITIES DEMAND

Quality metrics


Create a single view of the truth Make data instantly available for

analysis and reports Make the metrics visible


Data Integrity – a Challenge in Manufacturing?


Manual Batch Report

has to support

A Attributable: Is it traceable to a person, date, and subject visit?

L Legible: Is it clear enough to read?

C Contemporaneous: Was it recorded as it happened?

O Original: Is it the first place data is recorded?

A Accurate: Are all the details correct?


What does it mean in greater depth?


A Attributable: Is it traceable to a person, date, and subject visit?

L Legible: Is it clear enough to read?

C Contemporaneous: Was it recorded as it happened?

O Original: Is it the first place data is recorded?

A Accurate: Are all the details correct?

This Data Integrity Challenge using paper sources will require: Much more information ! Much more procedure !!

Much more control !!! Much more cost !!!!

has to support

Manual Batch Report

Paper


Data Integrity approach with EBR solution


offers

A Electronic system will automatically track information and enable electronic signatures. Data is attributable to a unique user with a secure password and role-based permissions, preventing changes from being made by unauthorized users.

L Electronic source records typically solve the illegible handwriting problem, because data and information are presented in a clean and standardized format.

C Automatic date and time stamps support this every time data is entered, edited, or modified in an electronic system.

O When the first record is electronic, an audit trail can track any and all subsequent queries and changes.

A When the source is electronic, audit trails can provide transparency to prevent data from being altered in a way that is difficult to detect. Additionally, automatic edit checks can immediately alert when missing data points or out-of-range data are entered.

EBR


PAS-X: For today and the future way of manufacturing

Basis is eliminating paper with a mature life science MES 1

Model any new processes (e.g. continous and single use) 2

Open and smart integration leading to Industry 4.0 3

MES is the key component facilitating Quality Metrics 4

EBR is the Data Integrity engine for the shop floor 5

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5 good reasons to decide for PAS-X MES


More than software: Best practices included! 2.

Ready to go out of the box! Quick implementation 3.

Regulatory compliance per global standards 4.

Ready for Industry 4.0 & Internet of Things 5.

1. 100% focused on Pharma & Biotech


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Thank you for your attention

GET ON BOARD TODAY!

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NEW WAY TO MANAGE YOUR PRODUCTION: MES SUPPORTS DATA INTEGRITY · NEW WAY TO MANAGE YOUR PRODUCTION: MES SUPPORTS DATA INTEGRITY . Werum IT Solutions – the leading MES supplier