PILOT:Suite - CheckVision

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PILOT:Suite

Functional Overview

Content

Felten Group – PILOT:Suite V1.0 Page I of II

Content

1 General Information ...................................................................................................... 1

1.1 Felten Group ........................................................................................................................1

2 Product Portfolio ........................................................................................................... 2

2.1 PILOT:Suite ..........................................................................................................................3

2.2 PILOT Multifunctional Terminal ............................................................................................4

2.2.1 Multifunctional Terminal Features ........................................................................5

2.2.2 Multifunctional Terminal Benefits ..........................................................................6

2.3 PILOT:MES Manufacturing Execution System ....................................................................7

2.3.1 PILOT: MES Features ..........................................................................................8

2.3.2 PILOT : MES Benefits ..........................................................................................8

2.3.3 PILOT: MES Add Ons ..........................................................................................9

2.3.4 PILOT: EBR Electronic Batch Recording .............................................................9

2.4 PILOT: WDS Weighing and Dosing System ..................................................................... 10

2.4.1 PILOT: WDS Features ....................................................................................... 11

2.4.2 PILOT : WDS Benefits ....................................................................................... 11

2.5 PILOT:APM Advanced Performance Management .......................................................... 12

2.5.1 PILOT: APM Features ....................................................................................... 13

2.5.2 PILOT: APM Benefits ........................................................................................ 13

2.5.3 PILOT: APM Add Ons ....................................................................................... 13

2.6 PILOT:APS Advanced Planning & Scheduling ................................................................. 14

2.6.1 PILOT: APS Features ........................................................................................ 15

2.6.2 PILOT: APS Benefits ......................................................................................... 15

2.7 PILOT: Shift - Management .............................................................................................. 15

2.8 PILOT:WMS Warehouse Management System ............................................................... 16

2.8.1 PILOT: WMS Features ...................................................................................... 17

2.8.2 PILOT: WMS Benefits ....................................................................................... 17

2.9 PILOT:LES Logistic Execution System ............................................................................. 18

2.9.1 PILOT: LES Features ........................................................................................ 18

2.9.2 PILOT: LES Benefits ......................................................................................... 19

2.10 PILOT:QMS Quality Management .................................................................................... 20

2.10.1 PILOT: QMS Features ....................................................................................... 21

2.10.2 PILOT: QMS Benefits ........................................................................................ 21

2.11 PILOT:CPO Control Plan Organizer ................................................................................. 22

2.11.1 PILOT: CPO Features ....................................................................................... 23

2.12 PILOT:Maintain ................................................................................................................. 24

Content

Felten Group – PILOT:Suite V1.0 Page II of II

2.12.1 PILOT: Maintain Features ................................................................................. 25

2.12.2 PILOT: Maintain Benefits ................................................................................... 25

2.13 PILOT:EMS Energy Management System ....................................................................... 26

2.13.1 PILOT: EMS Features ....................................................................................... 27

2.13.2 PILOT: EMS Benefits ........................................................................................ 27

2.14 PILOT:ERP-Connector ..................................................................................................... 27

2.15 PILOT:IO-Connector ......................................................................................................... 27

3 Project Implementation Strategies............................................................................. 28

3.1 IT-System Structure .......................................................................................................... 29

3.2 Data Collection .................................................................................................................. 30

3.3 Project Team ..................................................................................................................... 31

3.4 Support .............................................................................................................................. 32

3.4.1 Support Features ............................................................................................... 32

3.5 Project Management ......................................................................................................... 33

3.6 Implementation Management ........................................................................................... 34

3.7 Validation Strategy ............................................................................................................ 35

General Information

Felten Group – PILOT:Suite V1.0 Page 1 of 36

1 General Information

1.1 Felten Group

As a Software and Consultant Company, FELTEN Group has been focusing on

the development of software and solutions for the pharmaceutical, food, flavor,

cosmetics and paper industry from 1990.

With 6 locations in Germany, Luxembourg (location of production management),

Poland and the United Kingdom, We developed 50 software solutions with high

added value and having in consideration innovating thinking, excellent

competencies and many years of experience.

The PILOT: Suite of Felten Group has been successfully introduced into production

management in more than 36 countries worldwide. As a result Felten has many

years of know-how and experience with the introduction of specific IT systems.

(E.g. MES, QMS, APS, MDE, BDE, OEE, MAINTAIN, Production controlling, etc.).

Our customers include: Boehringer Ingelheim Pharma GmbH & Co. KG, Bio-Rad

AG, Fagron BV, Henkel AG & Co. KGaA, Symrise AG, Beiersdorf AG, Paper mill

Adolf Jass.

Image 1: Felten Group - References

Product Portfolio


2 Product Portfolio

To implement your requirements, PILOT:Suite provides the following modules.

Image 2: Pilot Suite: Portfolio

Product Portfolio


2.1 PILOT:Suite

PILOT: Suite is a Software-Platform that includes various modules for the planning

and control of your companies and production processes.

Modules can be implemented in their standard configuration or adapt specifically

to the customer’s environment and requirements.

The web-based PILOT: Suite is compatible with all popular browsers. Data is

stored in a relational database. The acquisition and display of data is possible by

mobile data acquisition devices (E.g. PDA, tablet, etc.) and terminals connected to

the system. Also it is possible printing labels and the execution of reports in

different file formats. E.g. Adobe PDF, MS Excel, etc.

PILOT: Suite offers the possibility of a hierarchical representation of a company.

Different levels of authorization for individual organizational units, the system has

rights and roles management, requirements for login and logout, password

assignment and multilingual options. Also enables logging and traceability of all

processes in the system.

Image 3: Pilot Suite: Connectivity

Product Portfolio


2.2 PILOT Multifunctional Terminal

A typical everyday life for an employee is carrying out their tasks on different

devices or in many cases using paper forms. However FELTEN multifunctional

terminal provides all the necessary information a user could need for his work area

in one place and on a user-optimized surface. All papers and documentation are

completely digitalized.

Real time data from the shop floor as well as ERP master data are communicated

bidirectional via PILOT: Suite and are available to the user via the most modern

web technology. Employees can be inform in an accurate manner and safely

guided through the process, either stationary on the multifunctional terminal or on

mobile terminals.

Image 4: Multifunctional Terminal User Interface

The design and the content in the system has been arrange flexibly in order to

provide the staff with the exact amount of important information they need to

prepare the next work steps efficiently. The current order and shift performance

displays the production target/actual comparison and motivates then to achieve

the set goals.

Product Portfolio


Image 5: Terminal Structure, Examples

2.2.1 Multifunctional Terminal Features

Capable of controlling over one to more Production Facilities at the same

time.

Manages visual and graphical components with different information from

the modules related with the production cycle. E.g. Production Orders,

Downtimes, Maintenance events, etc.

Provides internal knowledge of the effectiveness and efficiency of

production operations using the most relevant KPI’s for each production

facility or a total KPI related with production process.

Collect and show information as a Trend, so the staff in charge can analyze

this graphical information.

Offers the possibility to show some value documentation for the staff on

charge of a line or production facility. E.g. Machine manuals, System

manuals, etc.

Displays all the previous information using graphical and statistical

graphical components that can show the customer the real status of the

production process.

Product Portfolio


2.2.2 Multifunctional Terminal Benefits

Better organization of the production process.

Gives to the customer a general and specific view of what is really

happening in the production process.

Allows the customer to acknowledge, analyze and compare previous and

present information for a better decision making process.

Helps the company to increase production performance based on previous

miscalculations or configuration errors.

Control over the production process without involving paperwork.

Easy customization related to the User interface using graphical, visual,

statistical components.

Product Portfolio


2.3 PILOT:MES Manufacturing Execution System

PILOT: MES is the central instance and data hub of production management. This

solution creates a network of the information and accelerates the production

process between planning and execution. It also ensures more efficient use and

performance of production facilities.

Functionalities of PILOT: MES will become indispensable during the time of a

comprehensive digital networking in production. For that, the solution is at the

same time a crucial bridge to the industrial world, where horizontal integration is

fundamental for connecting all functions and data across the value chains.

Because Industry 4.0-Scenario requires decentralized real-time data to be

provided at production times, use of machines, human resources, material and

energy consumption and more, no future model can function without an MES

infrastructure with ERP integration. Because of that, the introduction of modern

MES landscape is an investment-safe issue that would also generate a high

economic benefit and thereby effectively supports the lean endeavors.

Image 6: Pilot Suite: Vertical Integration

Product Portfolio


2.3.1 PILOT: MES Features

Flexible production-planning (MES Scheduler).

Automatic process-control and monitoring.

User and master data management.

Equipment & resource management and order management.

In process control & LIMS functionalities.

Warehouse management, KANBAM, material scheduling and dispatch.

Maintenance.

Operating and machine data acquisition.

Report management.

Document management.

ERP Interface.

Track & Tracing.

2.3.2 PILOT : MES Benefits

A unique technology with the approach for more intelligent production

processes.

Future-proofed through the Industry 4.0-oriented systems concept.

Creates more flexible process models

Reduces production costs sustainably, significantly increases capacity and

produces higher quality.

Hidden potential efficiencies are located and easily exploited.

Guarantees a fast ROI and high investment security.

Product Portfolio


2.3.3 PILOT: MES Add Ons

PILOT: Working Plan: This add on is designed to combine different

production orders with the same material components and to weigh the

materials simultaneously. All events and consumption will still be allocated

to the individual orders, and documented.

PILOT: API Calculation: Assists with the calculation of the pharmaceutical

active- and binding-ingredients for batch-related weighing (API

concentration).

PILOT: Production Order: This allows the automatic translation of existing

customer orders into executable part-orders. PILOT: MES calculates the

part-orders based on available recipes and equipment (container capacity,

measurement ranges, etc.).

PILOT: Filling Order: Was developed to convert customer or production

orders automatically into orders for filling and packaging (for example,

several customer orders for the same product, etc.). All events and

consumption are also assigned to individual customer or production orders,

and documented.

PILOT: Inline printing: Delivers a high level of automation in the printing

and labeling of products, intermediate products or packaging with fast

location changes and customizations, also can be made in the course of

the production process.

2.3.4 PILOT: EBR Electronic Batch Recording

PILOT: EBR: for Electronic Batch Record Management takes

pharmaceutical companies a long way towards full production digitization.

It provides a consistent electronic and GMP-compliant process for recipe

creation, through weighing and validation of production data, to complete

documentation, including batch records. In this it takes all regulatory rules

and requirements, such as FDA, EMA, AMG, cGxP etc., into account.

The master batch record (MBR) with the creation and management of

recipes (according to ISA-95/ISA-88 standards) forms the basis of the

manufacturing instructions. These include for example the definition of

workflows, general conditions, the equipment and the quality requirements.

This information is transmitted to the following operational processes:

weighing, dosing, production data validation and the collection of additional

data. PILOT:EBR then documents all production steps based on the MBR.

Among the many user benefits are simplified batch testing and release. In

addition, LIMS, central building control systems, process control and other

systems can be integrated, via the appropriate interfaces.

PILOT: Recipe Management: Allows product manufacturing to be

described and documented easily as the individual process steps and

materials required. Recipes can be created directly from an existing

production order, or equally can be produced independently of an order.

Production with different systems and machines is also possible.

Additionally PILOT: Recipe Management responds flexibly to changes in

raw material, by recalculating the recipe quantities.

Product Portfolio


2.4 PILOT: WDS Weighing and Dosing System

Weighing and dosing operations are anything but trivial: firstly, to be efficient these

procedures must be integrated into the production processes, producing efficiency

and other benefits, and secondly the product requirements demand a high level of

precision and documentation. The whole process should ideally be digital, for

efficiency and additional benefits. For these reasons the PILOT:WDS solution

stands out. The system can be used with all popular weighing-scales and terminals

and easily integrated into existing systems such as MES, PPS or ERP/SAP.

The modularly-structured FELTEN solution has a range of other benefits. The

system is 21 CFR Part 11-compliant and hence has an easily-used backwards-

tracking capability thanks to electronic batch recording (EBR). In addition, the

labelling of sub-batches or intermediate products using the bar code system

ensures simpler, more secure identification during subsequent processing.

Image 7: Pilot WDS: Terminal Menus

Product Portfolio


2.4.1 PILOT: WDS Features

Order- or material-related weighing

Fully-automated weighing including taring

Part-weighing for container or LOT-number changes

Validity checks to assist users in weighing and dosing operations

Simplification of control operations by supporting barcodes for all activities

Weighing dialogue with minimal manual input

Functions for active ingredients calculation, material identification, PDA and

bar-code label printing

2.4.2 PILOT : WDS Benefits

Clear increase in efficiency and cost optimization throughout the entire

workflow

Helpful transparency through analysis and reporting

Direct conversion of production orders into weighing tasks

Automatic documentation and feedback of actual material usage (EWC)

Tracking and tracing of all process, weighing and container data

Error reduction through barcode / transponder support

Hardware independence for both terminals and weigh-scales

Guaranteed quality through FDA / GMP compliance

Product Portfolio


2.5 PILOT:APM Advanced Performance Management

Production companies are subject to a constant cost pressure due to changing

market requirements. In order to increase the profitability of the company, the staff

must be deployed efficiently, the plants operated optimally, the maintenance

management should be aligned as best as possible, and the resources

consumption should be minimized.

However, this can only be achieved if there is a high degree of transparency in all

relevant performance factors: Potential for optimization must be identified

continuously and risks already identified by means of key figures. And this is

important in terms of cost, effectiveness, productivity, quality, service and

sustainability. In addition, this information must be available in real-time, for

example, production disturbances can be identified immediately and can be

rectified immediately.

PILOT: APM was developed precisely for this requirement of production control.

This solution for advanced performance management includes components for

data collection, analysis, evaluation and communication. And by selecting and

preparing the key figures for all levels, they offer active support for targeted

optimizations to the employees or responsible persons in the respective task

functions.

The special advantage: for all controlling requirements, key figures are pre-defined,

available at the touch of a button and can be used immediately.

Image 8: PILOT: APM Terminal

Product Portfolio


2.5.1 PILOT: APM Features

freely-definable measurements

ability to call up current or historical process values or states

individual trend displays

numerous chart types and freely-configurable report systems for display

and documentation of the recorded data and results

configuration of groups and process lines

capture of malfunction causes

recording of downtime and changes in status

shift-, order-, batch- and line-related analyses of the machine data

KPIs and OEE calculations, using the formula-editor

Add ons for the management and analysis of employee usage in production

and line visualization on large-screen display

2.5.2 PILOT: APM Benefits

the causes of production disruptions can be identified directly and can

usually be cleared immediately

the level of production downtime will be substantially reduced

the system and process resources can be exploited systematically

better quality means higher yield, a lower complaint rate and more satisfied

customers the system actively supports company cost-reduction

strategies

Best Practices speed up systems implementation and support a minimal-

administration operation

it will pave the way to Production Intelligence

sustainability is guaranteed by in-house systems

accelerates RoI

2.5.3 PILOT: APM Add Ons

PILOT: Personnel Management: This add on is designed to manage and

analyze personnel use during production. You can record the operating

times for each process station, and the operator times and numbers per

employee. A parallel recording system for different cost centers is also

possible, including feedback to your ERP system (the ERP Connector must

be used).

PILOT:External Display: offers templates for a line visualization within

current production as a large-screen display. Potential displays are order

data, production line status, machine status, target and actual performance

data, etc. The display contents are fully configurable.

Product Portfolio


2.6 PILOT:APS Advanced Planning & Scheduling

The more precise planning is, the more effective and cost-effective the production.

Therefore, no production can work without planning using an Advanced Planning

and Scheduling System (APS). PILOT: APS with the holistic planning of all

production steps is the ideal solution for this. It helps to configure, control and plan

the supply chain. A variety of different parameters are considered in the areas of

resources, processes, order processing, raw material and quality. Also a simulation

of the production processes including the secondary processes like cleaning or

similar. Is possible according to various criteria, for example, the effects of the

failure of a machine can be recognized and can be re-scheduled accordingly in

seconds.

This tool gives the managers a comprehensive overview of the current status of

the production and at the same time an outlook on the future status. And as the

entire production process can be visualized, potential bottlenecks can also be

calculated. PILOT: APS ensures significantly shorter through times, reduces

inventories and leads to significant savings in both fixed and variable costs.

Intelligent planning logic also offers significant advantages in the synchronization

of the entire production processes. In addition, the production process is

accelerated because numerous best practice parameters are stored. And last but

not least, the solution can be easily integrated into SAP and other ERP systems

via the PILOT: ERP connector.

Image 9: PILOT: APS System

Product Portfolio


2.6.1 PILOT: APS Features

Intelligent Scheduling logic

Integrated production planning for all production steps including service

departments (e.g. maintenance).

Takes resources into account (e.g. equipment and operating stuff) in

planning.

Full presentation of production in both, as the current state and as a

forecast.

Production sequences can be prioritized by customer, resource, product,

etc.

Integrated data transfer and communication with:

o The scheduled job start forwarded to the MES/OEE system.

o Update all operator terminals and the connected systems.

o Feedback and data exchange with ERP system.

o Confirm the current timestamp to the PILOT: APS system.

Automatic rescheduling after production deviations appear.

Planning control on the basis on real time key data.

2.6.2 PILOT: APS Benefits

Integrated production planning for all production steps, including

maintenance.

Process steps are automatically created and planned from customer orders

from the ERP.

Production sequences can be prioritize by customer, resource, product,

etc.

Automatic rescheduling after production irregularities appear.

Planning control on the basis of real time key data.

No paper-based operations.

Shorter cycle times

Significant savings in both fixed and variable costs

Clear advantages on the synchronization of the entire production process.

Accelerates production process by using numerous Best Practice

parameters.

2.7 PILOT: Shift - Management

With this module, you can create an individually adjustable production

management layer with layer-specific and order-specific personnel time recording.

It offers the possibility to configure systematic and hierarchically arranged shift

plans with different shift times and different shift models. This not only simplifies

planning with less effort and, at the same time, improves the transparency of the

personnel use, but also important data can be collected and passed on to the ERP

system. This can be used, for example, to support personnel planning as well as

cost- and cost-related cost analyzes or further evaluations.

Product Portfolio


2.8 PILOT:WMS Warehouse Management System

The economic requirements of production in themselves require that everything

needed to provide goods should be made available in the necessary quantity and

quality at the right time and in the right place. This can only be achieved using a

warehouse management system with a timely, location-based digital stock

management system which supports the goods-inwards and dispatch area

processes.

PILOT:WMS has been developed to meet this requirement for managing and

optimizing in-house storage systems. This configurable software ensures process

and cost optimization in storage locations and regions. It helps to manage the

inventory of storage locations and consumption, as well as transport requests for

raw materials or finished products.

For stock-holding, the system allows for an annual inventory using mobile- and

barcode-aided logging of all current stocks, to compare estimated and actual stock

levels. The actual stock levels can in turn be transmitted to compare with the

balances in an upstream ERP system. Moreover, checkable documentation for all

warehouse receipts and issues in the warehouse makes real-time stock control

possible. The PILOT:ERP Connector also supports integration by enabling the

automatic exchange of WMS-related data with the SAP/ERP system.

Image 10: PILOT: WMS KANBAN Monitor

Product Portfolio


2.8.1 PILOT: WMS Features

storage locations and regions are freely configurable

manages the inventory of storage locations and consumption, as well as

transport requests for raw materials or finished products

mobile- and barcode-aided logging of all current stocks, in order to compare

estimated and actual stock levels in an annual inventory check

Where appropriate the actual stock levels can be transmitted to compare

with the balances in an upstream ERP system

material requirements and availability planning, based on actual material

consumption at the allocation and usage areas

Kanban strategies are included in the system (monitors, material

availability, etc.)

2.8.2 PILOT: WMS Benefits

accurate inventory data resulting from integrated systems (e.g. material

consumption booked during the weighing operation)

integrated data transfer & communication

logistics KPI monitoring & reporting

o inventory levels always up to date for material planning and

procurement

o automatic data exchange with ERP

stock levels controlled with the selected materials management strategy,

e.g. FIFO, Kanban

Material supplies to production according to current consumption (just-in-

time delivery)

cycle times are reduced by time savings in warehousing, relocations, and

the provisioning and availability of materials

Product Portfolio


2.9 PILOT:LES Logistic Execution System

Productivity and efficiency in production are closely linked to well-functioning

internal logistics. Ultimately, incoming materials have to be received, stored and

registered: a task for which PILOT:LES has been created. This Logistics Execution

System provides a field-proven performance profile of all the necessary functions

for managing the internal and external goods receipts. This Logistics Execution

System provides a field-tested performance range of all the necessary functions

for goods-inwards management, both internal and external. The ERP-Connector

for LES thus allows the automatic exchange of LES-related data (such as material

master data, order data, postings in the ERP warehouse etc.) with the ERP system.

Thus production management has permanent maximum visibility of orders

including supplier, due date and status, as well as an overview of current transport

usage. In addition, the system offers reception control (laboratory, clearance of

raw materials, suppliers’ quality control, etc.) In addition, various add ons are

available to manage returns to suppliers, customer complaints and shipping.

PILOT also offers an add on for the digital management of the existing goods-

inwards and dispatch areas. A link to an external GPS-tracking system is also

available.

Image 11: PILOT:LES Receiving

2.9.1 PILOT: LES Features

Overview of orders including supplier, due date and status, as well as an

overview of your current transport use.

Reception control (laboratory, clearance of raw materials, suppliers’ quality

control, etc.)

supplier returns - management of returns to your suppliers

customer returns - management of returns from your customers

Product Portfolio


Managing external and internal movements as well as in shipping control

(e .g. laboratory, material allocation, etc.)

Management of the existing goods-inwards and dispatch areas such as

gates, ramps, etc.

set of standard KPIs included

2.9.2 PILOT: LES Benefits

all information is available, using the integrated networking of all systems

no paper-based operations, transport orders are created automatically

pallets are automatically positioned in accordance with the guidelines

reduced time and space overheads from material warehousing and

repositioning

annual inventory-taking no longer necessary

material deliveries for production correspond to actual consumption (just-

in-time delivery)

cycle times are reduced by time savings in warehousing, relocations, and

the provisioning and availability of materials

Product Portfolio


2.10 PILOT:QMS Quality Management

The increase in customer requirements and the need to provide information about

the measures taken to reach quality assurance require detailed test documents

with an inspection and test plan. PILOT: QMS has been developed for this special

requirement of automated test planning and test drawing generation.

One of the most important characteristic of this system is flexibility. E.g. it can be

used ideally as a tool in continuous processes improvement (KVP) or in in-process

controls.

For this purpose, different type of questions can be created and combined with a

different weighing. In addition, the information can be stored as to whether the

answer to the question is relevant for the overall test or not.

Surely, questions about the property type can also be flexible combined with test

plans. Test plans can also be inherited. The special features of PILOT: QMS

include the fact that a workflow is supported and every step is documented. The

test results can be evaluated with the PILOT: Report or exported to Excel.

Image 12: PILOT QMS LMS

Product Portfolio


2.10.1 PILOT: QMS Features

Operators are guided and assisted through the process.

Continuous identification of out-of-specs states using define quality criteria

for all production steps, from the arrival of materials to the dispatch of

finished products.

Quality checks are configured individually according to specific times,

product groups, product categories, etc.

Systematic evaluation to all quality data through the system.

Efficient complain management.

Integrated data communication and transfer.

o Key data monitoring and quality.

o Standard quality reports.

o Automatic data exchange with ERP/SAP systems.

Digital management and documentation instead of paper base operations.

2.10.2 PILOT: QMS Benefits

All information is available for use, using the integrating networking of all

systems.

Automatic creation of lots for inspection.

Audit plans and checklists will be available where needed via desktop or

mobile device.

Automatic assignment of audit plans and checklists as appropriate to the

product in matter.

Connecting the measuring devices to the system allows automatic

comparison of the values measured with the specification and prevents

input errors.

Visual guidance using photos, instructions, notes (E.g. GHS Hazard

Symbols) can be provide at any time.

Cost and time savings through digital-supported quality-assurance

process.

Product Portfolio


2.11 PILOT:CPO Control Plan Organizer

The increase of customer requirements and the need to provide information about

the measures taken to ensure quality assurance require detailed test documents

with an inspection plan and a test drawing. The Control Plan Organizer PILOT:

CPO was developed for this special requirement of automated test planning and

test drawing generation.

One of the most important characteristic of this system is flexibility. E.g. it can be

used ideally as a tool in continuous improvement processes (KVP) or in in-process

controls, for testing boiler temperatures or for testing calibration cycles of

measuring instruments. Other fields of application can be the sampling of the

samples in the laboratory information system (LIMS), checking of user rights or a

check of the professional profile of employees.

For this purpose, questions of different types can be created and combined with a

different weighting. In addition, the information can be stored as to whether the

answer to the question is relevant for the overall test result or not.

Of course, questions about the property type can also be combined in a flexible

manner with test plans. Test plans can also be inherited. Among the peculiarities

of PILOT: CPO also includes the fact that a workflow is supported and every step

is documented. The test results can be evaluated with the PILOT report or exported

for Excel.

Image 13: PILOT CPO Control Plan Organizer

Product Portfolio


2.11.1 PILOT: CPO Features

Inspection plans can be assigned to a specific material, material class or

equipment.

Easy dialog-creation, assignment and clear presentation of all test points and

test details.

Simple way of changing status of a test plan.

Conclusion of several test points for test plans in relation to products or

materials.

Presentation of the complete test plan history including questions, test points

and testing procedures.

Evaluations / Analysis by product and material based on quality (by product

group, period, etc.).

Definition of escalation levels for active notification or critical test criteria.

Product Portfolio


2.12 PILOT:Maintain

Maintenance processes are becoming more and more critical to production

because machine failures and inadequate availability of machine resources have

a major impact on productivity. Especially since is necessary to take into account

that requirements for maintenance management are increasing as a result of the

progressive automation and simultaneously growing complexity in the production

structures. This leaves substantial possibilities for optimization of productivity

unused.

PILOT: Maintain provides effective support for risk-based maintenance. This

solution has a connection to machines and diagnostic systems for the automatic

detection of defined states (temperature monitoring, runtime monitoring, vibration

measurements, etc.). It documents the results of the impact analyzes (FMEA),

base on which maintenance orders are defined. In addition, the system makes it

possible to plan the maintenance orders and to visualize the planning in a calendar.

Likewise, maintenance-specific analyzes are possible due to the complete

documentation of all maintenance activities. And also the SAP / ERP integration

for the automatic exchange of maintenance-related data is included. As a result,

there is less administrative effort, because replacement and spare parts are

checked and retrieved on the system.

Image 14: Maintenance steps

Product Portfolio


2.12.1 PILOT: Maintain Features

Complete integration with ERP and other systems.

Maintenance stuff and activities automatically integrated into the production

planning and key data.

Maintenance planning and completion are linked to technical materials

stored.

Maintenance activities and technical materials stock are based on a risk

based assessment.

Integrated data transfer and communications.

Maintenance reporting and key data monitoring.

Automatic data exchange with ERP system.

Avoiding paper documentation by using mobile devices.

2.12.2 PILOT: Maintain Benefits

Fully digital and paper-free support for the creation and processing of work

orders in the system.

Activity durations will recorded automatically.

Less administrative effort because spare parts and consumables are

checked on the spot in the system inventory.

Parts are automatically allocated to the job and booked from stock.

Defining a minimum inventory level automatically initiates an order

requisition by mouse click.

Connections to machines and diagnostics systems to detect defined

conditions automatically (temperature monitoring, run-time monitoring,

vibration, measurements, etc.).

Visual guidance using photos, instructions, etc. for specific operations.

All information is made available using the integrated networking of all

systems involved.

Product Portfolio


2.13 PILOT:EMS Energy Management System

Almost all production companies have to prove their energy efficiency for legal

reasons or they pursue strategies to reduce energy consumption, independently of

these requirements. PILOT:EMS is ideal for this. The solution meets the

requirements of the standards according to DIN EN 16247-1 or ISO 50001 and is

recognized as eligible energy management software by the competent Federal

Office for Economic Affairs and Export Control (BAFA).

PILOT:EMS is a comprehensive analysis of the energy demand and the CO

Balance, but above all the calculated consumption values can be systematically

optimized through an intelligent action management.

For a good reason, PILOT:EMS is based on the PILOT:APM solution, which is

used to determine operating and process data. It is designed in such a way that it

not only ensures a much more efficient production management, but at the same

time supports the requirements of modern energy management. The decisive

advantage is no additional investment for the technical infrastructure for the

specification of relevant data and identification of energy guzzlers as well as load

points and measures for their reduction for this easy-to-integrate and future-

oriented web technology.

Image 15: Examples EMS Diagram

Product Portfolio


2.13.1 PILOT: EMS Features

Full support of DIN EN ISO 50001

Fully supports the PDCA cycle (Plan, Do, Check, Act).

Evaluation of Key Indicators according to DIN EN ISO 50001 and EMAS III.

Analysis and evaluation with the help of coaching views and trend outlooks.

Evaluation of key data using formula editor.

Integrated reporting system.

Quick and easy data connection using PILOT I/O Server.

Simple integration using forward-looking web technology.

All data available on mobile devices (Blackberry, IPhone, IPad).

2.13.2 PILOT: EMS Benefits

Transparent energy monitoring for efficient emission controls.

Production disruptions automatically trigger optimization measures.

Significant added-value, compared to conventional systems, by displaying

energy consumption in relation to production in a single system.

Modular system expanding flexibly with requirements.

Best Practices speed up systems implementation and support a minimal-

administration operation.

Sustainability guarantee by in-house systems.

High level of investment security by using a next generation intelligent

information system.

2.14 PILOT:ERP-Connector

PILOT: ERP connector provides the connection from MES to existing ERP

systems. It coordinates the data exchange between the two systems and supports

the transfer of orders and lists as well as master data.

Consumption data, production data, key figures, times as well as quality data are

reported back to the ERP.

2.15 PILOT:IO-Connector

PILOT: IO connector provides an interface to various systems, data transmission

from the OPC interface to the MDE / OEE application, and data buffering in case

of connection interruptions to the PILOT application

Project Implementation Strategies


3 Project Implementation Strategies

Felten leads their customers step by step in the optimization of their production.

Consulting:

Process Optimization

MES / ERP Integration

Production Controlling

Industry 4.0

PILOT Platform:

Best Practice Modules

Easy Scalable

Digital Orientation

Quick RoI

Project Management:

Experienced Teams

Best Practice Methods

Key User Concept / Train-the-Trainers

Budget / Timeline Controlling

Service & Support:

Workshops, Trainings

24/7, 365 days worldwide

Update Management

1st to 3rd Level Support



3.1 IT-System Structure

Our hosting concept has been successively developed since 1997 in many projects

and rollouts with numerous satisfied customers. Depending on the existing

infrastructure, it consists of two main points: the central server and the local IO

connector (s).

Image 16: Overview PILOT System Landscape

PILOT: IO-Connector provides the interfaces to production. For simple handling of

the process communication it is normally located in the local environment. It

provides a variety of interfaces and also serves as a data buffer if the application

server should not be available.

The PILOT application server is usually located virtually together with regional or

local ERP hosting in a server room or data center.



3.2 Data Collection

Data Collection in PILOT system is carried out in two different ways.

1. On Process Client /Touch-Terminal-PC

Manual Data entry on the process control during processing orders. For example:

- Correction of goods / Bad pieces counter

- Fault qualifications for non-automatic fault detection.

- Manual process input / Test Plans

2. PILOT:IO-Connector

The IO connector is used for automated data collection. The data can be

exchanged via different drivers (methods). Various versions are available as

standard. For example: OPC, OPC-UA, ODBC, Serial, Native Driver, etc.

- CSV, TAG-Lists, XML, File, etc.

Image 17: PILOT:IO-Connector



3.3 Project Team

We are in close contact with our customers through the duration of the project and

will integrate the most important user groups into the project right from the start.

This allows us to ensure a high level of acceptance of our system as well as a fast

and easy implementation.

As the main contact partner, an experienced project manager is available as a

single contact person.

Image 18: Project Team Concept



3.4 Support

In order to minimize interruptions in operation plants, support is a key element of

our strategy.

We provide worldwide support via remote access. Through individual Agreements

we guarantee a support up to 24/7.

Within the support management, all incidents and service requests are collected

centrally in a ticket system and forwarded to the responsible employees for the

first- and second-level support.

The service management also includes third-level support. This service also

includes research to develop solutions for the long-term elimination of faults.

On request, we provide local key users for first-level support. A local system

integrator can also perform this service.

3.4.1 Support Features

Workshops & Key User Training

Updates without Production stop

24/7 Support, 365 days worldwide

Support by diagnostic module

Documentation in a Ticket System

Covering of 1. - 3. Level Support



3.5 Project Management

Project implementation is carried out according to the requirements of the QM

system based on the defined Project Life Cycle.

Image 19: Project Management

Established procedures, such as design specification, followed by the

implementation of the requirements and tests are join by our QA and an

experienced project management.

At an early stage, we integrate our customers into project implementation with

reviews and releases at defined milestones as well as tests.



3.6 Implementation Management

We use the release management system to plan, define and control version tests

and their rollout into the production system.

This allows us to ensure that each new software or module version meets the

expected requirements, the customer's productive system is protected against

failures and only tested versions are executed.

In order to determine faulty processes at an early stage and to avoid software

accidents within production, we configure three different servers for each project:

One Development System for development and general test done by

Felten.

One Test System for training, testing of implementation results and system

extensions as well as analysis of our customer, but outside the production

area.

One Productive System for the real production areas.

Image 20: PILOT Integration Strategy

Our test processes and document templates meet the requirements for validation

according to GAMP 5.

For the definition and documentation of the tests, corresponding template

documents are available.



3.7 Validation Strategy

In addition to the above-described implementation concepts, we offer validation

support for pharmaceutical systems. These refer to the entire validation as well as

to corresponding support.

The diagram illustrates the basic validation process of the Felten Group.

We follow the specifications of the MQP (Master Qualification Plan) of the customers as well as the dedicated specifications of a project-specific QPP (Quality and Project Plan).

For the validation documentation related document templates are available in the Felten Group. The templates follow exactly the specifications of GAMP 5. Possible adaptations of these templates depend on the customer's validation strategies.

On request, also available document templates of the customer can be used for the validation.

Image 21: Validation Process

In general, this results in individual work steps which can be represented as

follows.

Project realization Validation / Qualification

Creation of validation plan together with the

user, if necessary

Specification of the customer requirements in

the URS (User Requirements Specification) together with the user, if necessary

Creation of Quality and Project Plan

• Specification of functions in Functional Specification (FS) or Design Specification (DS)

Creation and actualization of the traceability matrix (TM) together with the project team, including required design reviews

Definition of software categories according to

GAMP5 with regard to risk analysis (PILOT modules are usually category 4)

Execution / supervision of the risk analysis for the evaluation of the risk filters. The template of the RA can be adapted to customer requirements

Project Realization, Customizing

Execution of Design Qualification



Creation of Test Documentation FAT / SAT

Review Test Documentation (FAT, SAT) together with the Project team

Setup Test systeme

Creation of test documentation (IQ, OQ, PQ) according to standard templates Note: The tests are partly documented in the TM. Tests can also be carried out according to customer documents.

Internal Testing

FAT Accompanying the FAT, if necessary

Implementation, Training SAT Accompanying the SAT, if necessary

Execution and Documentation IQ, OQ, PQ

Creating Validation Report

The individual points are clearly documented in the traceability matrix (TM).

The general validation process is as follows:

- Setup & Customizing on the Test System

Execution of the FAT

- Transfer of the Application into the Q-System

Execution of the SAT and pre-validation (IQ / OQ).

If necessary, the target hardware can be connected.

- Transfer of the Application into the Productive System

Finalization of the SAT and IQ / OQ together with the target hardware

- Go-Live and PQ

In general, the PQ is carried out by the user himself.

This concept supports the realization strategies of core-systems followed by

rollouts (internal and additional sites supported by customer’s key users.

The core system can thus also be "pre-validated" at the other sites. The validation

effort will thereby be greatly reduced.

Image Register

Felten Group – PILOT:Suite V1.0 Page I of I

Image Register

Image 1: Felten Group - References ..................................................................................... 1

Image 2: Pilot Suite: Portfolio ................................................................................................ 2

Image 3: Pilot Suite: Connectivity .......................................................................................... 3

Image 4: Multifunctional Terminal User Interface ................................................................... 4

Image 5: Terminal Structure, Examples ................................................................................. 5

Image 6: Pilot Suite: Vertical Integration ................................................................................ 7

Image 7: Pilot WDS: Terminal Menus ...................................................................................10

Image 8: PILOT: APM Terminal ............................................................................................12

Image 9: PILOT: APS System ..............................................................................................14

Image 10: PILOT: WMS KANBAN Monitor ...........................................................................16

Image 11: PILOT:LES Receiving ..........................................................................................18

Image 12: PILOT QMS LMS .................................................................................................20

Image 13: PILOT CPO Control Plan Organizer.....................................................................22

Image 14: Maintenance steps ...............................................................................................24

Image 15: Examples EMS Diagram ......................................................................................26

Image 16: Overview PILOT System Landscape ...................................................................29

Image 17: PILOT:IO-Connector ............................................................................................30

Image 18: Project Team Concept .........................................................................................31

Image 19: Project Management ............................................................................................33

Image 20: PILOT Integration Strategy ..................................................................................34

Image 21: Validation Process ...............................................................................................35

FELTEN GmbH

In den Doerrwiesen 31

54455 Serrig

Tel: +49 6581 9169 – 0

www.felten-group.com

PILOT:Suite - CheckVision

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