Life Sciences Serialization Suite. Taking serialization beyond regulatory standards. software.schneider-electric.com/lsserialization

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1 Life Sciences Serialization Suite Taking serialization beyond regulatory standards software.schneider-electric.com/lsserialization

2 software.schneider-electric.com/lsserialization 2 Serialization Compliance: A Critical Factor Serialization compliance marks an important milestone for the life sciences industry, with several countries setting new regulations for traceability of prescription drug and biologic products. In order to facilitate this, the serialization process has to be put in place beforehand. Today, the majority of the world is adopting the GS1 Standards (www.gs1us.org) in their serialization process. Adopting these standards requires the assignment of unique, traceable numbers to individual items or saleable units. The labeling must happen at the plant floor level where packaging lines are located. All new inventories distributed after the due date set by local regulations, which differs from country to country, has to contain serialization information and a logistics data carrier. This is a symbol that can be scanned with a device, a barcode being one example. Undoubtedly, serialization has many advantages benefiting both end users and pharmaceutical manufacturers alike. Serialization enables a drug to be tracked and traced electronically as it passes through the supply chain. This means that, at any point, authorities and pharmaceutical companies are able to: Identify and stop the distribution of counterfeited drugs Contain and track the source of contaminated drugs back to its source Handle product recalls more efficiently and effectively Life Sciences Serialization Suite: The Schneider Electric Value Some pharmaceutical companies have already started implementing the serialization process. One of the biggest challenges they face is implementing a serialization solution with data that can be easily harmonized with existing operations management solutions such as a Manufacturing Execution System (MES). The Life Sciences Serialization Suite by Schneider Electric is a turnkey offer that brings harmonization between legacy production applications such as MES and Quality systems, providing an all-inclusive track, trace and reporting solution for a line, a site, or the enterprise. Thanks to out-of-the-box integration with MES/ Quality applications, the Life Sciences Serialization Suite enables: End-to-end Track and Trace from manufacturing through supply chain Integrated analytics from production to the end user Real-time supply chain visibility, enabling more accurate planning and scheduling decisions Print and Apply Regulatory Compliance Serialization Schneider Electric Value Business Maturity Integrated Production Analytics Track and Trace Real Time Supply Chain Visibility With the Life Sciences Serialization Suite, speed to deployment is faster, reducing the Total Cost of Ownership for pharmaceutical companies with less substantial changes to the underlying manufacturing systems and business systems. Integration of serialization data back into the MES makes it possible to have real-time visibility across the supply chain, from the manufacturing world right up to the end consumer.

3 software.schneider-electric.com/lsserialization 3 Key Features of Life Sciences Serialization Suite Ability to easily create templates such as: Aggregation at each parent in the packaging hierarchy Serialization at each level without aggregation Serialization at a specific level Flexibility to switch between GTIN and SSCC codes at any level Specific modules for rework and printing Out-of-the-box integration with native MES applications Localization capabilities Analytics and reports such as: Serialization OEE (Overall Equipment Effectiveness) comparative analysis Tracking by serial number stock overview, usage analysis, wastage analysis, SKU serialization report Line Serialization Module Site Serialization Module Life Sciences Serialization Suite Analytics & Reports Master Data Configuration

4 4 software.schneider-electric.com/lsserialization Serialized Numeric Identifier Aggregation and Inference Accuracy Real-time Supply Chain Visibility Regulatory Compliance

5 5 software.schneider-electric.com/lsserialization Business Value of the Life Sciences Serialization Suite The Life Sciences Serialization Suite is designed for use at the plant line level and site level and works seamlessly with existing business systems. The solution allows for integration of operational data, including serialization information into existing MES systems. Its highly scalable and secure architecture caters to current and future expansion requirements. Benefits include: Enhanced workflow process additional control for site notification events to the enterprise Centralized data source for analytics and reporting Harmonized database structure for report development Single source for all site data Supports site metric/comparison reports Site Serialization Site DB P C E P C E P C E Station 1 Integrated Master Station 2 Line Serialization Station 3 Line 1 Line 2 P C E P C E P C E OR OR Standalone Master Standalone Master Site: Receive order details from ERP Site: Create a packaging order Site: Get serial numbers from EPCIS (GS1) Site: Serialization dispatches order to specific lines Line: Receive order Line: Start and Complete printing Line: Upload the serial number statistics and Aggregation data to Site Site: Send commissioning information to EPCIS (GS1) Site: Generate Analytics reports, and archive serialization data (typically for 12 years) Station 1 Station 2 Station 3 Line 3 P Printer OR C E Camera Ejector P C E P C E P C E Station 1 Station 2 Station 3 Standalone Master

6 software.schneider-electric.com/lsserialization 6 Life Sciences Serialization Suite Bundle Hardware Line Serizlization Site Serizlization Enterprise LS Serialization Suite Scope Out of Scope ERP Wonderware Skelta BPM Site DB MS SQL Site DB MS SQL Server Server MS SQL Server (Only for Master) InTouch ME Embedded Compact OEM Line Serialization Engine OEM Printer and Camera Drivers Printer Cameras Ejector EPCIS (Tracelink) One per Site per Station per Station Bundle Offers: Schneider Electric Life Sciences Serialization Suite Site Serialization Module for 2 Lines Site Serialization Module for 5 Lines Site Serialization Module for 10 Lines Site Serialization Module for 15 Lines Line Serialization Palletization Station Customer FIRST Software Maintenance and Support Program Our Mission: Your Success The Customer FIRST Software Maintenance and Support Program is a flexible portfolio of services that help protect and extend the value of your Schneider Electric Industry Solution across the entire lifecycle. A Customer FIRST Agreement establishes a formal service relationship with Schneider Electric, enabling access to the latest software upgrades and providing expert technical assistance, optional services and self-help tools to help you improve your operational effectiveness. For more information on Customer FIRST for Industry Solutions, please visit software.schneider-electric.com/support/customer-first. For more information on the Life Sciences Serialization suite, please visit software.schneider-electric.com/lsserialization

7 Schneider Electric Life Sciences Serialization Suite Rancho Pkwy South, Lake Forest, CA Phone: +1 (949) Fax: +1 (949) Schneider Electric Software, LLC. All rights reserved. PN SE-0231 Rev. 05/16 This document has been printed on recycled paper

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