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Comprehensive Pilot Software Suite
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Maximum Adaptability & Performance
by Centralized Management Software
The PCE Pilot software suite ensures high performance packaging including
coding, serialization, labelling, verification and quality inspection. Starting
from single item serialization via bundle, shipping case to pallet, the
innova-tive software suite supports dedicated device and system control as well as
data exchange with higher level IT systems. Thanks to our modular and highly
configurable systems, manufacturers can upgrade their processes as required
to comply with new legislation and thereby protect existing investments.
Key Benefits
• Easy to administer and orchestrate all control and printing devices • Flexibility to work with stand-alone machines or complete lines • Fast set up due to central user, order and product management • One solution for all countries world-wide, enabling compliance with a
wide range of local legal requirements
• Simple integration of customized ERP systems by configurable design • SAP certified software
Cameras,
Sensors,
etc
SCADA, PLC, PAC
MES
ERP
Enterprise
Level
Management
Level
Supervision
Level
Field/
Control
Level
ERP
Pilot Site
Manager
Pilot Line
Manager
When a simple code reading/ verifying or a quality inspec-tion is required, our Inspecinspec-tion Manager (IM) handles the con-nection to the implanted devices. Barcodes, datamatrix codes, pdf-documents, jpg-pictures – the software provides the connected devices with the relevant infor-mation. Statistics about correctly or incorrectly classified products give information about produc-tion or packaging quality. Ad-ditional good/bad signals can be used for further processing
Site Management
Today’s track and trace packag-ing can easily integrate different devices like cameras, printers, scanners and machine control. Our line management solution (Pilot Line Manager) additionally handles order information and product data, packagingformats and codes, serial numbers and picture information on all levels of aggregation and equipment. Based on a production database (Pilot Database) it can be linked to PCE’s upper level site management system (Pilot Site Manager). At any
Today’s business requires fast and reliable information about all production processes. Top man-agement, supply chain partners, regulatory authority and other parties require accurate and up-to-date information about production performance, product and packag-ing quality and codpackag-ings. Our site management software (Pilot Site Manager) is directly connected to the production database (Pilot Database) and can be linked to upper level ERP systems as well. This gives access to information
Line Management
Simple Inspection
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Manage all Your
Track & Trace Lines
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Handle your Track & Trace tasks on all your production lines with one Tool.
The Pilot Site Manager (PSM) provides enterprise-wide visibility of
produc-tion data.
This enables management to make well-founded business decisions. PSM is capable of supporting multiple line solutions. PSM forms the basis for unique item-level serialization and aggregation of serial numbers to packaging units. PCE’s software manages the writing, reading, and printing of serial numbers – and the provisioning of serial numbers within the packaging environment. Pharmaceutical manufacturers can be assured its compliance with legal requirements and brand protection demands while laying the foundation to met future serialization regulations. All PCE systems are standards-based and 21 CFR Part 11 compliant.
ERP
other
Product-Information Order-Information Serial-Numbers Line-Information Receipe Formats GTIN Country Code other Order ID Lot Number Expiring Date Shipping Information Customer ID ... Algorithm List Ranges ID Lot Aggregation Uptime Procuction-timePLM (Pilot Line Manager)
PSM (Pilot Site Manager)
Your Benefits
• Accurate information about every production line on your desktop • Continuous order information
• Automatic reporting with statistics and diagrams
Mobile Pilot Manager
The mobile Pilot Manager
(mPM) gives you access to the
Pilot Site Manager (PSM)
soft-ware and the installed track and
trace devices. The mobile
solu-tion enables users to do almost
everything that can be done on
the stationary devices.
Opera-tors or administraOpera-tors can easily
control several lines by using the
order management module.
Pilot
Suite
Flexible Con nec tivity to ER P Sca lab le Mul tip le D ev ice W or ld w ide Stan dardsIntegrated Workflow
Connect your Track & trace lines easily to your ERP system. Our closed loop solutions ensure an integrated data flow with your IT systems. Pre determined serial numbers feed the line devices and infor-mation about packed products is send back to the ERP.
SAP / ERP
AII
PCE SAP Connector ImportE xport ERP Connector Import Export ERP Connector PCE, Customer or third party connection toolPSM (Pilot Site Manager)
PCE Web Services
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As part of Pilot Software Suite the Pilot Line Manager
(PLM) monitors production in real-time, controls machine
functionality, data collection and reporting. PLM also
ad-ministrates and orchestrates intelligent devices on a single
packaging machine or complete packaging lines via
Ether-net Ether-network. PLM manages the production line activity and
data functions necessary to support performance metrics,
serialization and aggregation activities. That guarantees
maximum security in the packaging process. All PCE
sys-tems are standards-based and 21 CFR Part 11 compliant.
High Performance Track & Trace Lines
Pharma Packaging
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PSM
Pilot Line Manager
Pilot Database
Formats,
Codes
Serialization
...
Coding & Verifying Aggregation Code-Reading Quality-Inspection DatamatrixStation AdvancedBundle Station
Rank 2 Rank 3 Rank 4 Rank ... Shipping Case Station Pallet Packer/ Manual Aggregation Station Smart
Camera MegapixelSmart Camera ...
Your Benefits
• PLM is the preferred management and control instrument for your complete Track & Trace line
• It gives you access to all of your Track & Trace status
• Comprehensive presettings and import functions ensure short make- ready times
• The carefully elaborated software guarantees long uptimes and mini-mum maintenance
• Standardized and robust interfaces integrate all devices offering out-standing system performance
• The flexible and modular software design is able to easily meet increas-ingly complex future requirements (when indicated, a software upgrade might be necessary)
• The powerful reporting engine provides online, pdf or excel reports by the click of a mouse
Inspection Manager
• Management and control devices like cameras and of scanners
• Suitable for simple vision
• inspection configurations • Delivering of format information
and reference codes to cam-eras and scanners
• Provides basic counting and
• statistics of your production • Can be easily integrated in
ex-isting environments
Pilot Database
The Pilot Database (PDB) is the common information platform for Pilot Site Manager (PSM) and for Pilot Line Manger (PLM). It handles the data flow between users, lines, orders and upper level systems. The database scheme has been specifically developed for high performance storage and high speed produc-tion. Preferred database systems are Microsoft SQL Server and
Oracle 11g. Schemes provide user management, format handling, line management, product information and order management systems as well as provision for audit trail and system configuration. PDB requires a customer based general database infrastructure (hardware, network, software).
For more information
www.mt.com/pce
Pharmacontrol Electronic GmbH A member of the METTLER TOLEDO group Gernsheimer Straße 2
64673 Zwingenberg, Germany Telephone +49-6251-85 45-0 Facsimile +49-6251-85 45-111 E-mail [email protected] Subject to technical modifications ©Pharmacontrol Electronic GmbH Printed in Germany 0912/011 EN
Our Aim Is
Your Performance
Our complete systems ensure high performance and reliability throughout your production process. Prerequisites such as robust software ensure the continuous development and review of processes - ensuring Good Manufacturing Process in your daily production. We follow a similar Good Development Process in software development.
1. Carefully gathering and agreeing on requirements.
2. Object-oriented definition of functional specifications and design patterns
3. Module design and implementation as well as documentation 4. Module testing, documentation and, if necessary, further iterations 5. System integration testing, documentation and if necessary further
iterations
6. Factory or site acceptance tests as well as operational qualification
Our experienced development team ensure all projects conform to global regulations. This includes:
•
GAMP5 based Requirement Definition•
CVS Source Code Management•
Milestone definition and TRAC-System•
Change Management•
Release Management•
Support over life cycle•
21 CFR Part 11 compliance•
ValidationWith the PCE solutions you benefit directly from over 20 years experience in the pharmaceutical industries. In over 400 production lines around the world PCE solutions observe, code and verify millions of pharma packages every day.
