PAS-X SOFTWARE

BUSINESS FUNCTIONS

www.werum.com
 PAS-X Software

PAS-X Business Functions

The business functions provided by PAS-X cover all areas related to specification, manufactur-
ing control, quality assurance, and process optimization.

The functional architecture of PAS-X closely follows the ANSI/ISA 95 standard.

Process
Development Master
SPECIFICATION Batch
IMP Records
Manufacturing

Electronic Material
Finite Weighing & Equipment Warehouse
EXECUTION Scheduling Dispensing
Batch
Management
Flow &
Management
Recording Inventory

Track &
Process Trace
COMPLIANCE Quality
Control Serialization
Aggregation

Manufacturing
PERFORMANCE Intelligence

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A tailored Start-up Process

PAS-X offers you flexible, scalable product configurations to cover your specific needs. The
incremental step-by-step deployment approach secures your investment and allows money
and time spent on individual projects to be evaluated precisely.

Based on the business functions provided by the PAS-X product, we have designed various
tailored packages for you.

Start-up Packages

Start-up Packages are small-scale packages focusing on a specific functionality. These start-
up packages can be upgraded. Start with a small solution and extend it on a step-by-step
basis - up to a functionally complete full-scope MES system.

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Proccess Development
IMP Manufacturing

Accelerated development and scale-up of manufacturing processes

PAS-X Process Development simplifies and speeds up the modeling of manufacturing pro-
cesses for pre-clinical and clinical production. It is available as a standalone product or an
integrated Business Function of Werum‘s PAS-X Manufacturing IT Business Platform.

PROCESS DEVELOPMENT

Pre-Clinical Clinical /IMP Launch &

Laboratory
Production Production Commercial Production

TECHNICAL BATCHES Fine Chemicals

Flexible & Open Workflows

Process Design Biopharma

Blood Plasma
Vaccines

Guided Workflows
Liquids
Solids

CLINICAL BATCHES
Process Scale-up

FASTER TIME TO MARKET

The goals and drivers of PAS-X with respect to process development are as follows:

Business

–– Accelerated and enhanced MBR development, MBR validation and batch record review
–– High process visibility due to a single system for all stages
–– Agile response to changing clinical trials demands
–– High flexibility while maintaining GMP-compliant status

Knowledge transfer

–– Simplified transfer of processes from development stage to commercial production

using structured information
–– Supporting an open, flexible approach for development of technical batches
–– Collection of all GMP-relevant data
–– Predefined library elements to accelerate scale-up process ensuring flexibility and
observing compliance requirements
–– Supporting a collaborative approach
–– Allowing on-the-fly definition of the batch record structure at early development stages
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Process development

–– Integrated Design of Experiments (DoE) features

–– Reliable identification of Critical Process Parameters
(CPP) and Critical Quality Attributes (CQA)
–– Enabling Quality by Design (QbD)

Why PAS-X Process Development?

–– Fast and flexible MBR development

–– Seamless knowledge transfer from
development to commercial production
–– High degree of flexibility in early-stage batch recording
–– DoE approach for CPP and CQA identification to enable QbD
–– Improved process visibility, data analysis and information transfer

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 PAS-X Software

Master Batch Records

Structured Management of Master Batch Records

Master Batch Records (MBRs) are general manufacturing instructions. Batch Records are
derived from them and refer to a specific order. Master batch records and batch records are
therefore the basis for a precise and detailed description of pharmaceutical manufacturing
processes. They contain all pharmaceutically relevant data: the input material list, valid SOPs,
detailed work instructions to be applied in production, and also process data, or process
steps, such as in-process controls (IPCs), Critical Process Parameters (CPPs) and Critical
Quality Attributes (CQAs).

Even today, conventional word processing systems are often used to create and maintain
master batch records and batch records. The final result is paper documentation. It really is an
uphill struggle: Time-consuming and error-prone manual reconciliation or approval procedures
are required to carry out tasks like structuring, maintaining and managing versions of master
batch records for reconciling data with the ERP system.

Master Batch Records, by contrast, is based on structured master batch records which are
subject to automatic version management and which use libraries with reusable building
blocks. The use of standardized building blocks makes it much easier for the user to create
and maintain master batch records.

In particular, PAS-X also administers those recipe elements which are specific to interfaced
process control systems (DCS/SCADA). An integration layer that is independent from the ac-
tual control system enables the general definition of recipes, which are then implemented in a
way suiting the specific control system used.

Master Batch Records structured by means of predefined Building Blocks

Master Batch Records maps master batch re-

cords as graphical structures:

Master Batch Records allows the user to set

up libraries with standardized, reusable buil-
ding blocks which can then be used to create
a master batch record. These building blocks
are subject to version management. Master
batch records are defined and displayed using
a graphical design tool.

The applied master batch record structure

meets the requirements of the ANSI/ISA 88 /
95 standards.
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Parameterization of Unit Procedures for Automation and Process Control Systems

In fully automated production environments, the standardization of production recipes is mo-

ved to level 3 of the S95 model.

Thus, the MES becomes the leading system for the definition of recipes while these are actually
executed at the level of the process control system. The relevant data tags can be managed
as logical or physical tags.

Master Batch Records is an intelligent Business Function

When master batch records are created, Master Batch Records carries out defined checks
to ensure plausibility and completeness.

For this purpose, it is possible to set the parameters for more than 50 different test criteria.
For instance, it can be checked whether the recipe specifies the required target values for
the process. If specifications are missing at any point, the system will display a message to
the user.

Master Batch Records calculates material quantities across entire MBRs and lists totals of
all input material quantities in BOMs. Yield calculations are also taken into account, as they
permit the drawing up of the requested „material balance sheets“.

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Electronic Approval Workflows

Master Batch Records supports all workflows necessary for review and approval. The system
will notify all peopled concerned by e-mail and then deliver the required documents in electro-
nic form directly to the relevant user‘s desk. Any corrections and changes to the master batch
records are made and documented within the system itself. Electronic signatures are used to
sign approvals in compliance with 21 CFR Part 11.

Master Batch Records facilitates and simplifies workflows, shortening approval cycles and
therefore drastically reducing associated documentation work.

Integration with ERP Systems

Master Batch Records provides standard interfaces to all leading ERP systems. By means of
configuration, Master Batch Records can be adjusted to the requirements for different ERP
systems. Depending on the specific ERP system, the contents will be simple bills of material or
routing structures. When generating orders, Master Batch Records will fill in missing informati-
on and maintain it in FDA/GMP-compliant manner.

This business function thus offers an essential benefit in the context of software system valida-
tion: Master Batch Records business function includes all software functions which are subject
to validation and can therefore be validated as master system for the creation of master batch
records. It is no longer necessary to carry out additional validation for the higher-level ERP
system, which would be costly and time-consuming.

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 PAS-X Software

Finite Scheduling

Shop Floor Scheduling

Finite Scheduling is a PAS-X business function that enables detailed scheduling of production
processes. Since it includes functions for checking material availability and controlling order
processing, it is an ideal complement to the ERP system, adding specific shop floor scheduling
functionality.

Finite Scheduling is highly scaleable and easy to expand. Its functionality ranges from simple
to complex. For example, it has uncomplicated, clear, well-arranged graphics, which map the
current order status to a chart and allow the user to take manual control. It also offers complex
„intelligent“ algorithm-supported production scheduling features.

Finite Scheduling adds more shop floor scheduling and control functionality to an ERP system‘s
production planning functionality. Graphic planning boards provide a quick overview of the
most important scheduling details; they help the user visualize and optimize complex relation-
ships and make it easier to modify order scenarios down to the shop floor level.

Finite Scheduling has a modular structure. This gives the schedulers the flexibility they need
to decide by how much they want the software to support them in planning the production
process.

Order Control

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For the purpose of detailed production planning, Finite Scheduling uses the specifications
defined in the ERP system. Finite Scheduling can either directly access the master batch
records managed and maintained in the Master Batch Records business function or retrieve
routings from the ERP system. If these routings already contain production planning details,
Finite Scheduling adopts the orders in corresponding sequence using certified interfaces. The
scheduler can then optimize them for the production process by means of the provided simu-
lation and finite scheduling functions.

The scheduler can use the simulation functions to develop several production scenarios and
to compare them to one another. Graphic evaluation functions create the basis for selecting
the most favorable production model. In the context of detailed planning, Finite Scheduling
considers marginal conditions which previous production planning operations have not taken
into account. Some of these conditions are:

- capacities of systems, machines and staff

- production preparation times
- downtimes and maintenance periods
- set-up and cleaning times
- product compatibilities
- material availabilities
- information on material status
- release periods

Materials Planning

The Materials Planning business sub-function provides the option to integrate material usage
and material availability checks into the scheduling process.

In this context, the focus is on production-integrated scheduling. Finite Scheduling supports

the planning operations for material staging and for controlling material replenishment. This
functionality is of special importance for production environments requiring large quantities of
material. Usually, long-term stockpiling of such materials is not possible and such materials
must be delivered just-in-time for use. The periods required to approve raw materials and
semi-finished products additionally affect the planning process. They are taken into account in
the production-based material availability check.
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Planning Cockpit

The most important feature in production scheduling is a constant feedback from the manufac-
turing process. In a continuous actual-to-target value comparison, Finite Scheduling compares
the planned production situation to the actual situation. Malfunctions may affect schedules,
bottleneck resources and delays in productions. Instantaneous feedback from the shop floor
level based on recorded process data, such as malfunctions, enables the scheduler to take
necessary actions at an early stage, whenever necessary.

Transparent Planning Process

The PAS-X Workplace Concept provides workplace-related dialogs tailored to all users and
their individual scope of duties. In addition, anyone involved in the production process, be it
supervisors or production managers, can directly view the current status of production sche-
duling. Of course, PAS-X can also make the same information available to an extended group
of people, e.g. the sales & marketing team. Thus, the system provides all employees with
information that is relevant to them personally.

Evaluations

Finite Scheduling provides standardized evaluations to enable optimized production

scheduling, such as:

- product-oriented evaluations
- machine-oriented evaluations
- capacity evaluations
- stock-oriented evaluations

Open interfaces enable an export of the scheduling data to Analysis Tools for the purpose of
additional, individual evaluations.

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Weighing & Dispensing

The PAS-X Business Function for Weighing & Dispensing

The precise Weighing & Dispensing of input

materials based on recipe specifications is
at the core of any pharmaceutical manuf-
acturing process. Accurate data collection
within this first processing step is funda-
mental to batch tracking and documentati-
on. In a reliable and „easy-to-operate“ way,
the Weighing & Dispensing system guides
the user through the weighing process and
provides the necessary support for compli-
ance with safety regulations and recipes.

Weighing & Dispensing

- Guides the operator through the entire weighing process with user-friendly
electronic work instructions on the screen
- Controls any kind of weighing operation including manual and automated weighing,
dispensing and filling processes - and thus increases the quality of the weighing process
- Enables automatic campaign building and execution
- Generates complete labels according to customer-specific parameters
- Carries out plausibility checks on materials, containers and scales through barcode
identification
- Monitors and supports the calibration of scales and sets up a scale logbook
- Supports the interfaces of all commercially available scale manufacturers
- Documents and archives data in accordance with GxP/FDA regulations for electronic
records and electronic signatures (21 CFR Part 11 compliant)
- Generates weighing reports and
- Maintains audit trails

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Manual Weighing

In the case of manual weighing operations

Weighing & Dispensing guides the user
through graphic operating dialogs, regar-
dless of the type of scale. Workflows for
material and container identification are
defined within the weighing instructions
and can easily be adjusted to individual
business processes simply by changing
parameters.
Source: Genzyme
The use of mobile radio terminals for weighing procedures ensures a high level of operator mo-
bility. Operators can make use of wireless barcode scan features to work in parallel at several
work centers following „easy-to-operate“ dialog instructions. Weighing & Dispensing ensures
that all workflows are carried out accurately and correctly, and it prevents the kind of mix-ups
and errors common to manual data entries.

Automated Weighing & Dispensing Operations

Weighing & Dispensing supports automated dispensing and filling systems, and provides stan-
dardized interfaces to PLC systems and dispensing control systems. Interfaced with the ERP
system the system administers bills of material and recipe parameters. These order-based
data are processed, documented and logged at all weighing stations. Werum‘s longstanding
expertise in the integration of automated systems ensures successful equipment integration
for all the different types of system components, even within explosion-proof areas.

Material Identification

Weighing & Dispensing ensures that the

specified input materials are actually used.
It therefore controls automated or manual
reading and identification operations which
can be based on barcode labels and
transponders. Weighing & Dispensing then
checks the data against the specifications
in the shop floor order.

Source: Schering-Plough
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 PAS-X Software

Electronic Batch Recording

Electronic Execution and Documentation of Batches

Efficient electronic and thus paperless batch documentation is one of the core objectives in
introducing Manufacturing Execution Systems in pharmaceutical production. In this, special
attention must be paid to the regulations of 21 CFR Part 11 Electronic Records; Electronic
Signatures.

With the Electronic Batch Recording function of PAS-X master batch records are electronically
executed and the processes and results are documented in compliance with the applicable
statutory provisions. PAS-X ensures an error-free execution of the entire production process.

„Easy-To-Operate“ User Prompting

Electronic Batch Recording offers user-friendly, standardized operating dialogs for the whole
production process. It covers all stages, such as the receiving of incoming goods, production
and packaging operations through to the shipping of finished products. The user interface is
graphical, but the system also visualizes batch records on screen in a paper-like fashion („Pa-
per on Glass“).

Rules Enforcement throughout the Process

The batch record displayed on screen includes all work instructions as they are required. So,
the user for example finds bills of input materials with complex formulas for value calculation or
specifications on individual process parameters like limiting values for the temperature. Even
complete Standard Operation Procedures (SOP) can be displayed on screen in their latest re-
leased versions when interfaced with a document management system. With displays in bold
red/yellow/green traffic signal fashion as well as dedicated role-based dialogs, PAS-X ensures
intuitive and ergonomic working for the user.

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Role-based Workplace Concept

Following a role-based workplace concept, PAS-X provides different optimized user display
modes and dialogs reflecting a user group‘s specific role in the production process. This me-
ans that various types of user interfaces are available for executing electronic batch records:

- Industrial PCs
- Mobile terminals
- PDAs
- Mobile notepads with touch-screens

The use of Radio Frequency (RF) capable mobi-

le terminals and notepads with integrated scan-
ners allows for maximum flexibility and freedom
of movement. The work instructions as well as
material plausibility checks based on scanner
input can be accessed by every user at any
place and at any required time.

Process Data View

A Distributed Control System (DCS) or Supervisory Control and Data Acquisition System (SCA-
DA) may be employed to control the process. In this case, the role-based workplace concept
of PAS-X offers integrated visualization of electronic work instructions and process data. This
way, the user obtains a homogenous picture of the process state.

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Equipment Integration

By integrating pharmaceutical process equipment via standardized interfaces PAS-X is able to

exploit all relevant data of the equipment level:

- Electronic Records / Electronic Signatures in compliance with 21 CFR Part 11

(for documentation/archiving purposes),
- Specifications/download of recipe parameters to the machine,
- Operating state data,
- Operational time accounts, and
- Malfunction data and periods.

PAS-X archives all process data in a 21 CFR Part 11-compliant way, with a particular focus on
CQAs and CPPs. All logged process data are thus available for evaluations and as a basis for
identifying the potential for optimization. (Manufacturing Intelligence)

Deviation Handling

During execution on shop floor level, Electronic Batch Recording continuously compares the
captured ACTUAL data to the SET values set forth by the batch record. In the event of a
deviation, the system immediately displays a traffic-light alert at the quality control panel. The
representation in red/yellow/green color enables corrective user intervention into the process
in good time. These and other deviation handling functions further enhance the broad PAS-X
portfolio and form a solid foundation for comprehensive deviation management.

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Material Flow Control

Electronic Batch Recording documents all materials used in course of the

production process. At the time of input, the system identifies and verifies
the input materials using the connected barcode readers or transponders.

In combination with the material flow control component of PAS-X, it

also enables control of all material transports with integrated container
management and facilitates integration with Automatic Guided Vehicles
(AGVs) or pallet handling systems.

Audit Trail

Electronic data that is produced duri-

ng execution on the shop floor (Elec-
tronic Records and Electronic Signa-
tures) is documented in accordance
with the requirements of 21 CFR Part
11.

Electronic Batch Record featuring

a Deviation Report

The electronic batch record summarizes the data to provide it in consolidated form for easy
and effective review at a PC saving a lot of time. Electronic Batch Recording also creates a
separate report on deviations. At a single glance, the persons in charge can grasp and assess
all information relevant to approval or rejection. The approval workflow can be configured in a
flexible fashion and define several persons and departments to be in charge.
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Batch Tracking with Graphical Batch Tree

The batch data captured throughout the production process is placed available in the Com-
pliant Historian Database of PAS-X for later analysis. To enable easy access, all pharmaceu-
tically relevant batch data and its links to other information is arranged in a graphical batch
tree. Moreover, there are standardized search functions helping the user to find specific batch
information.

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Equipment Management

Electronic Equipment Logbooks

Equipment Management uses as an example the Container Management business subfunc-

tion to administer and monitor the status of containers, receptacles and pallets. The system
keeps status lists, cleaning rules and histories for the individual container types in the form of
detailed logbooks.

During the weighing operation a plausibility check is carried out to ensure the suitability of sour-
ce and target containers. The container management component checks that the containers
which are being used meet the set requirements. Usually, barcodes or transponders are used
to ensure reliable container identification.

A comprehensive set of master data is allocated to each container, and includes data on tare
administration, complex rules for cleaning or sterilizing, product compatibility and possible
product sequences.

Equipment Management checks containers prior to their use, e.g. for cleaning status and
usability.

Equipment Management has much more to offer though. It administers cleaning procedures
for all types of production-related objects, including master batch records and particular rules
for cleaning scales, work rooms, containers, production equipment and setup parts as well
as toolkits. Even complex rules for sterilization and associated sterility expiration dates after
cleaning operations can be managed and monitored.

With Equipment Management, it is possible to control the assembling of individual equipment

modules into complex units and to use these complex units in the production process. In this
context, Equipment Management monitors and documents counter values and authorized,
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parameterizable equipment statuses and status changes.

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Material Flow & Inventory

In-plant Material Flow

One of the essential core functions of PAS-X is to secure

in-plant material flow throughout the pharmaceutical pro-
duction process.

The PAS-X business function Material Flow & Inventory is

made up of modules. It contains business subfunctions for
manual and automatic transport control as well as in-plant
administration of shop floor storage areas.

The business subfunctions for transport control cover the complete material flow, from goods
receipt, to quality control, to production, through to packaging, order picking and shipments.
By adding shop-floor-related functions for material flow control, Material Flow & Inventory is an
ideal complement to the material management functionality of classical ERP systems.

For example, it provides mobile terminals that support every transport and walk the operator
through the entire transport process.

Material Identification

Material Flow & Inventory ensures that the

materials used in pharmaceutical production
are uniquely identified on receipt by means
of barcodes or transponders. The system
supports a multi-step identification concept,
which starts with the labeling of pallets, inclu-
ding pallet documents, and reaches down to
single handling units.

Source: Schering Plough

Transport Control

Material Flow & Inventory supports flexible mapping of the entire material flow in production
and facilitates more efficient transport control procedures. All in-plant material movements are
logged in an audit trail. Through its tracking function, Material Flow & Inventory supports un-
interrupted tracking of the entire material flow. Standard information functions provide details
about material quantities, available batches, batch qualities, and storage locations. At all times,
users have access to the necessary work instructions and transport information via stationary
computers or mobile radio terminals.
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Cold Chain Monitoring

Special functions, such as cold chain monitoring for temperature-sensitive products, round off
the range of functions offered by Material Flow & Inventory.

Production Line Supply

Material Flow & Inventory uses the Order Picking business subfunction to compile in-
put materials for production (line supply). In other words the software is able to supply
the packaging lines, for example, with the required packaging materials. Material Flow &
Inventory also supports automatic control of material replenishment for production lines, par-
ticularly for large batches which have to be supplied in several steps.

Automated Transport Systems

Material Flow & Inventory also offers specific business subfunction which enable easy configu-
ration of different systems for transport control:

- automatic guided vehicles

- roller conveyors
- overhead conveyors

Forklift Control Systems

Material Flow & Inventory also includes a

Forklift Control business subfunction to
establish transport control features for
forklifts. The transport orders are commu-
nicated to the forklift through radio trans-
mission. Pending orders are displayed to
the driver on mobile terminals or forklift-
mounted terminals with a touch-screen.
Computer-supported forklift activities in-
crease transport safety and efficiency of
material flow operations. Even when a lar-
ge number of forklifts is interfaced to the
MES, the system still stands out and ope-
rates with a high degree of transparency
and efficiency.
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Warehouse Management

In-plant Warehouse Logistics

The PAS-X Warehouse Management business function supports production-related ware-

house logistics. The system components can be configured as required, and form the basis
for implementing

- Warehouse managements systems

- High-bay warehouse control systems
- Forklift control systems
- Order picking systems
- Computer-aided pick systems
(e.g. pick-to-light)

These systems are specifically designed to

meet the requirements of the regulated batch-
oriented industries.

Warehouse Management Systems

Use Warehouse Management to configure and

parameterize your storage locations and bins.
The system supports you in operating

- High-bay warehouses:
fully automated, semi-automated,
or manual
- Bin-based storage locations
- Storage locations for tanks
- Storage locations for silos

Order Picking Systems

Warehouse Management comes with a number of different configurable system components

for order picking.
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Order Picking for Production Floor

Warehouse Management deals with the material requests for production, e.g., for manufactur-
ing or packaging. This business function provides special picking functions, which may also
be implemented mobile terminals to facilitate flexible processing of the goods. For subsequent
transports, e.g., to the production floor, a transport order is initiated and processed. This
guarantees that the required materials are ready for use in production at the scheduled time.

Picking and Shipping

Warehouse Management can also handle the shipping of finished goods. In this case,
processing of the picking lists and staging of the goods for shipment is a joint task of the
Warehouse Management business function and an interfaced ERP system.

Goods Issue

The system provides comprehensive functions to render assistance in order picking trans-
actions involving large components, such as big bags and whole pallets, as well as smaller
individual handling units.

Computer-aided Pick Systems

To meet the special order picking requirements for small items, Warehouse Management enables
the configuration of computer-aided pick systems. These pick systems will usually consist of
picking racks or, alternatively, can be configured to guide the staff through the picking order
on mobile terminals.

Transparent Warehouse Management, Transport Control and Operator Guidance

Our warehouse and logistics systems have open ERP interfaces, which have already been
connected to various ERP systems.

In particular, we offer certified interfaces for SAP systems, which ensure transparency of your
warehouse management, transport control, and operator prompting.
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Process Quality Control

Continuous Quality Control during the Manufacturing Process

Quality control is of vital importance during the manufacturing process. Its objective is the con-
tinuous control and improvement of product quality.

The Process Quality Control business function offers you the PAS-X functionality that ensures
a continuous monitoring of the production quality. With this business function, you can pro-
cess any deviations from the specifications during ongoing manufacturing operations. But,
more importantly, you can use functions that support process-analytical on-line, in-line, and at-
line quality controls to take preventative and flexible measures in order to achieve the highest
possible quality. Process Quality Control supports you as you implement Process Analytical
Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.

Quality Control Dashboard

Process Quality Control supports qualified persons in their daily work. Quality Control Dash-
boards can be configured in flexible ways to show deviations in the different manufacturing and
packaging sectors on intuitive traffic light displays. The qualified person can directly intervene,
down to the batch record level, evaluate deviations with appropriate audit trails, and take ap-
propriate measures - all with a simple mouse click.

Deviations are actively displayed. You don’t have to hunt for them.

Deviations / events may directly initiate a CAPA process in an external system, e.g.,
Trackwise®. Standard interfaces to the CAPA system are available “out-of-the-box” (OOB).
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Electronic Batch Recording as the Basis

The step towards paperless documentation is a milestone on the path towards more reli-
ability and documentation quality in the pharmaceutical manufacturing sector. Electronic user
prompting guides the operator securely through all production steps of the manufacturing
process. Process Quality Control is a logical and consistent add-on to the Electronic Batch
Recording business function. Process Quality Control, with its core function of workflow-based
deviation management, makes good use of all the benefits of Electronic Batch Recording, and
it safely controls all critical parameters.

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Automated Deviation Tracking

With the help of the Electro-

nic Batch Recording business
function, all set values and
tolerance bands are unique-
ly specified within the pro-
cess, and are electronically
verified. On recognition of
deviations, Process Quality
Control informs the operator
and prompts for a response.

The electronic early warning mechanisms in Process Quality Control enable the user to take
corrective action regarding the production process the moment any negative trend is recorded.
Every single deviation is documented.

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Classifying Deviations

The system prompts the operator to classify re-

corded deviations and to add a comment. At
the same time, Process Quality Control checks
whether a second electronic signature is required.
The criteria for required second signatures can
be customized within the system. Furthermore,
subsequent actions can be parameterized. The
system can therefore, for example, in the case of
defined deviations, prompt the operator to notify
the supervisor in charge before continuing with
the process.

Analyzing Deviations

An electronic workflow ensures that deviations can be evaluated by different members of

staff and various departments. This method delivers two vital benefits: On the one hand,
time-consuming distribution of paper documents becomes redundant; on the other hand,
target and actual process data, required for evaluation, are made readily available.

Evaluating Deviations

Process Quality Control creates an electronic Deviation Report for the Electronic Batch Re-
cord. The deviation report is part of the electronic batch record. A condensed report of all
deviations allows the batch record to be released efficiently and with no unnecessary delays.
The release process is controlled by a parameterizable electronic document workflow.

Audit Trail

Once reported and evaluated, the de-

viations are stored within an audit trail.
The system documents electronic si-
gnatures in compliance with the 21 CFR
Part 11 requirements.

Process Quality Control therefore im-

proves the performance of all release
processes and, at the same time, fulfils
compliance regulations regarding the
documented pharmaceutical release
process.
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Track & Trace Serialization Aggregation

In close collaboration with its partners, Werum has developed a Track & Trace solution for the
pharmaceutical industry to comply with anticounterfeiting requirements for medical drugs.

PAS-X Track & Trace provides serialization and

aggregation functionality for packaging processes
and integrates the ERP and the Global Repository
with the shop floor packaging equipment and line
controllers.

Secure Track & Trace System Capabilities

Tracking is the process of monitoring products,

by means of a secure marker (identifier), as they
make their way to the consumer. In this way, a
time and location history is built for each product.

Tracing is the concept of being able to intercept and authenticate products and trace their route
back to the manufacturer. In this way, the time and location history of a specific product is retrieved.

Serialization is the unique identification of a medical product to avoid drug counterfeiting via
printing a unique serialization number on packaging units e.g. 2D barcode, RFID tag

PAS-X Track & Trace Key Functionalities

–– Support of GS1 labeling information

–– Management of modular packaging line layout incl. print layout recipe management
–– Management of serialization numbers in operations
–– Management of modular aggregation for e.g. item, bundle, pallets
–– Integration with centralized Track & Trace repositories using standards like EPCIS
–– Handling of packaging orders and batch information
–– Handling of mass data for serialization and aggregation processes:
–– Dialogs to create, discard, aggregate and disaggregate units and hierarchies
–– User management incl. rights management & audit trail
––Generation, randomization of serial numbers
––Support of multiple serial number formats e.g. SGTIN-96
––Providing serial number blocks to packaging lines
––Recording and reconciliation of used and unused serialization numbers

–– Packaging Line Performance Management Out of the Box using T&T connectivity
–– Analysis of OEE (Overall Equipment Effectiveness) for packaging processes
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PAS-X Track & Trace - Systemarchitektur

LEVEL 4

Central
ERP System
Repository

SAP ® Certified
Integration with SAP Applications
LEVEL 3

Packaging Solution
LEVEL 0-2

Manual
Line Controller
Packaging

–– 21 CFR Part 11 and Electronic Product Code Information Services (EPCIS) compliant
–– Support of EPC Tag Data Standard for electronic product coding, e.g. SSCC, GTIN
–– Standard interfaces:
–– Line Controller: Uhlmann, Seidenader, Systech International, etc.
–– ERP Systems: SAP, ORACLE, etc.
–– Central Repositories: ■
–– SAP (Auto-Id Infrastructure AII, Object Event Repository OER),
–– IBM (Info Sphere Traceability Server ISTS,
Websphere Sensor Events WSE),
–– Axway Track & Trace
–– Standalone system or integrated MES Business Function
–– Multiple language/Unicode support

Why PAS-X Track & Trace ?

–– Independent of ERP systems and line controllers

–– Rich product-based functionality “Out of the Box”
–– Covering global anti-counterfeiting requirements
–– Analysis of OEE
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Regulatory requirements and deadlines - worldwide

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Manufacturing Intelligence

Performance Management in Manufacturing

Data collected during manufacturing processes is valuable, in particular with regard to GMP
requirements, i. e. in the archiving of electronic batch records and in helping to identify areas
where the manufacturing process can be optimized. In order to be useful, however, this data
needs to be processed and analyzed in a suitable format.

Manufacturing Intelligence is a PAS-X business function which helps you to access manuf-
acturing data and assess it to enhance performance within your manufacturing processes.
Manufacturing Intelligence gives you business subfunctions as a basis for using specific criteria
to assess and evaluate your production processes, map them graphically, analyze them, and
optimize them to suit your specific requirements.

Werum offers access to the data through a number of different tools and for a variety of use
cases - for simple, printable reports all the way through to complex MII-based information por-
tals. The foundation for this is the transparent PAS-X data model to which the user has access
through different configurable methods.

Reporting

The transparent data model enables the user to access the data in PAS-X. The Crystal Reports
tool facilitates easy design and generation of reports. Our standard PAS-X delivery, which
varies according to the business functions used, contains preconfigured reports. Once you
are trained to work with Crystal Reports, you can modify these standard reports and adjust
them to your needs. You can also generate completely new reports using the Crystal Reports
Engine.

Performance Package

The evaluation package incorporated into Manufacturing Intelligence: provides you with pre-
defined evaluations based on PAS-X standard data models without the need for any configu-
ration on your part. For example, you can generate overview charts on materials, deviations or
process data for your manufacturing or packaging operations. Visual representation of the eva-
luation data in the form of diagrams makes it much easier to understand correlations, trends,
and results, and thus increases transparency in the pharmaceutical manufacturing process.

The performance function of Manufacturing Intelligence: is preconfigured and based on Qlik-

View software by QlikTech International AB. Quick implementation and intuitive operation
are among the most significant advantages of this software solution. Based on the standard
PAS-X data model, this evaluation package provides you with evaluations on the most impor-
tant manufacturing data.
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Through mouse click, the end user can display the evaluations in graphical form. Special stan-
dard functions make it easy for the user to filter out the relevant data from the comprehensive
data model and display it in a chart.

KPI Feature Package: Decision-Making Tool for Operational Excellence

The KPI Feature Package provides powerful functions for ensuring operational excellence and
lean manufacturing using PAS-X data for performance management.

The KPI Feature Package automatically acquires and evaluates all operating data on shop floor
monitors in real time – thus turning data into key figures to aid decisions. Operators and super-
visors can view the current status of the packaging lines at any time. If data is not provided by
the equipment, the KPI Feature Package also allows operators to manually enter the causes
of interruptions, such as setup times, pausing times or maintenance. This enables a gapless

100%
65% 98%

65%
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Preconfigured KPIs such as Overall Equipment Effectiveness (OEE), Capability and Availability
support transparent processes both for operators and the management. These KPIs can be
made available in standard reports immediately. The preconfigured and certified PAS-X stan-
dard interfaces guarantee a seamless data exchange with the shop floor equipment.

Why KPI Feature Package

–– Manufacturing intelligence tool

–– Real-time data acquisition and evaluation
–– Delivery of key figures to aid decisions
–– Continuous improvements ensured
–– Integrated and transparent data access across levels and systems

Key Benefits

–– Management: Reduction of costs – factors driving costs such as bottlenecks and reasons
for equipment downtimes can be identified easily.
–– Operator: Saving of time – data for performance management is available immediately
enabling the operator to focus on the production workflows.
–– Administration: Ease of configuration – all functions and data are available within a single
system.

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Integration with SAP MII and other BI solutions

When interfaced with business intelligence (BI) solutions, Manufacturing Intelligence offers fur-
ther options for determining global key performance indicators (KPI). This is enabled by the
open interface external data model of PAS-X. Reporting tools such as SAP MII, SAP Business
Objects, IBM Cognos or SAP Crystal Reports can thus use data from PAS-X for extensive

reporting and evaluations across systems and facilities in a global network.

Easy Integration - Maximum Benefit

Data evaluation with Manufacturing Intelligence provides transparency and enables objective
assessment, both of which eventually lead to optimization of your business processes. Simple
and individual configuration of key operating indicators to your own specifications allows for
highly flexible use
of your MES sys-
tem.
Manufacturing
Intelligence:
It pays!
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M4EN3