1. SERIALIZATION
Addressing the challenges of achieving supply chain serialization compliance
© 2015 Systech International. Last updated July 2015

2. DEADLINES ARE CLOSING IN
Regulatory Compliance
Manufacturing Impacts
Potential Quarantine
Evolving Regulations
Supplier Backlogs
CPO/CMOs Challenges
MULTIPLE REGIONS, VARIED REQUIREMENTS
© 2015 Systech International. Last updated July 2015

3. UNDERSTAND, IDENTIFY, PRIORITIZE AND DEPLOY
How ?
Identify compliance requirements
Asses impacts to your business and systems
Build a plan and identify gaps
Prioritize sites and lines
Understand your supply chain
Collaborate with trading partners
Start Now!!!
“..a scalable proven serialization solution that enables us to meet the changing marketing requirements and
effectively respond to global security challenges”
Ian Haynes, Principal Pharmaceutical Engineer AstraZeneca
© 2015 Systech International. Last updated July 2015

4. Implement a serialization solution that:
LEVEL 1 | DEVICE
LEVEL 2 | LINE
LEVEL 3 | SITE
LEVEL 4 | ENTERPRISE
LEVEL 0 | VERIFIED
LEVEL 5 | AUTHENTICATION
Implement a serialization solution that:
Provides serial number range management
Serial number validation
Meets regulatory compliance Can be upgraded and re-configured
Integrates with existing or new hardware
Deploys rapidly and scales with the business
Adapts to packaging and regulatory changes
Remotely supportable without having to wait for an engineer to arrive
© 2015 Systech International. Last updated July 2015

5. Storage, Warehousing & Reworks
PROVEN MODEL
INPUTS
Packaging on the Line
Interface
QA Release & Shipping
Storage, Warehousing & Reworks
Offline Operations
Database
© 2015 Systech International. Last updated July 2015

6. CASE STUDIES AND TESTIMONIALS
Requests
Upgrades to existing software
Additions of new lines
Global compliance needs
Delivery
Upgrades, FATs and SATs
25 lines in 1 year
Standardized, repeatable delivery
Business Impact
Timely implementation across global sites with multiple compliance regulations
“TBD - QUOTE HERE.”
NAME HERE
TITLE
COMPANY
© 2015 Systech International. Last updated July 2015

7. Only One truly integrated platform
WHY SYSTECH
Only One truly integrated platform
LEVEL 1 | DEVICE
LEVEL 2 | LINE
LEVEL 3 | SITE
LEVEL 4 | ENTERPRISE
LEVEL 0 | VERIFIED
LEVEL 5 | AUTHENTICATION
Eliminates hidden costs
All vendors have to be brought back in when changes have to be made to the line
Removes potential for data mismanagement
Multi-vendor = multiple failure points in architecture
Increase accountability
Single point of accountability for the total solution
VENDOR 4
VENDOR 3
VENDOR 2
VENDOR 1
RAPID DEPLOYMENT :
(more slines, maximize performance, constant upgrades)
Across all packaging operations – palletizing, post lot rework, QA release, shipping,
Only one to provide an end-to-end platform. Fully integrated.
© 2015 Systech International. Last updated July 2015

8. UNISERIES OPTIONS
© 2015 Systech International. Last updated July 2015

9. UNISERIES - PRODUCT FEATURES & BENEFITS
Only One Serialization Platform
Complete data management (end-end stack, one s/w platform/one set of interfaces)
Cross functional packaging capabilities (off-line, on-line, QA post lot etc..)
Over 200+ Standardized use cases
Regional and global options
KEY BENEFITS
Ensures data integrity and license to operate
Supports complete packing integration
Reduced TCO, minimized down-time
Rapid deployment & flexibility
Ability for in depth supply chain insight
Operational dashboards, analytics, an actionable intelligence
© 2015 Systech International. Last updated July 2015

10. PROVEN MODEL Rapid Deployment Reduces risk
Delivered standardized, tested solutions
Standardized Configurations
Over 200 Standard use case templates
Speed implementation, reduce risk, avoids mistakes, pitfalls, and protect investment
Flexibile Design
Patented configuration software
Reduces change costs
Minimizes downtime
Protects your investment
Adaptable
Meets packaging and regulatory needs
Add new regulations – Drop into existing deployed solutions
Infinitely Scalable
Supports any regional regulation or brand initiative with no customization
UniSeries reduces risk and delivers rapid deployments through solution standardization
© 2015 Systech International. Last updated July 2015

11. UNISERIES™ Regional and Global Compliance
© 2015 Systech International. Last updated July 2015

12. UNISERIES – GETTING INPUT
SIMPLIFIED – PREDESIGNED – STANDARDIZED – CONFIGURABLE
Universal formatting – meets all regulatory needs
Includes Serialized Number Range Management
INPUTS
Master Data
Bulk Manufacturing
Packaging Materials
ONLY ONE combining input into validated line configurations
© 2015 Systech International. Last updated July 2015

13. UNISERIES – ON THE LINE CAPABILITIES
MAXIMIZE THROUGHPUT & PROFITABILITY – MINIMIZE DOWNTIME
FLIXBILITY – A single line can run many ways including
Serialized and non-serialized formats with multiple product classes
CONTINUITY - Data Backup will run a complete lot even with a network interruption
AUTHENTICATION READY – Upgrade with UniSecure
FACT:
400 ppm
Serialized
FACT:
900 ppm
Non-serialized
FACT:
Lot Sizes of 2.5M
FACT:
Active Volume in Billions
ONLY ONE with a simulation environment for testing throughout operations
Systech’s 24x7x365 support handles issues so you can focus on production – Systech takes the ownership ensuring integrity of packaging process
The fact is that Systech has Sustained line speeds actively running in the Serialized market at 400 PPM – in the non-serialized space with have 900
© 2015 Systech International. Last updated July 2015

14. UNISERIES – POST-LOT CAPABILITIES
TRULY SCALABLE – ADD AS YOU GO…
FLEXIBLE Singular, All Encompassing Foundation – add processes, steps, reconfigurations and more..
Adaptable - Avoid costly reconfigurations
Palletizing – Automated / Manual & Centralized
Lot & Batch – Suspend & Resume
Reworks (Sandbox)
ONLY ONE with streamlined, centralized operations within the same system
Sandbox comes into play here too…as noted earlier. This is not something that has a one time value. As none of the other competitors have anything like you any change to their systems goes unwarranted and untested – leaving room for costly errors and downtime. [add support benefit here too]
© 2015 Systech International. Last updated July 2015

15. UNISERIES – STORAGE, WAREHOUSING & REWORKS
SINGULAR INTEGRATION – REDUCED DATA ENTRY
Easy integration
WMS, SAP, JD Edwards, QAD
Test integrations in a Sandbox environment
Stand alone operation
Doesn’t require any other software
Build as you go – Deploy today and add more for tomorrow…
Storage, rework, batch records and shipping preparation
Systech is the ONLY ONE to provide a single point of integration without a 3rd party vendor
SANDBOX NORE:
© 2015 Systech International. Last updated July 2015

16. UNISERIES – QA RELEASE AND SHIPMENT
DATA INTEGRITY – VALIDATION - PREPARATION
ENABLES - Final Line/Site Operation
Shipping prep, QA testing, Release, Shipment
Track-and-Trace ready
Seamless upgrade to UniTrace
Integrates with 3rd party Level 4
PROVEN, SCALEABLE, RELIABLE Platform
Infinite # Lines
Infinite # sites
Supports all number formats
Regional and Global options
ONLY ONE delivering a complete serialization solution stack with Track-and-Trace
Sandbox comes into play here too…as noted earlier. This is not something that has a one time value. As none of the other competitors have anything like you any change to their systems goes unwarranted and untested – leaving room for costly errors and downtime. [add support benefit here too]
© 2015 Systech International. Last updated July 2015

17. UNISCOPE – REGIONAL COMPLIANCE SOLUTION
One line support for One regional compliance
Benefits
Rapid implementation to reduce line downtime
Complete site, line and device level support
Efficient design and configuration
Future proofed compliance
Regional support for US, EU, Brazil, China and others
Upgradeable within Systech’s UniSeries
Features
Meets regional regulatory requirements
Supports in-lot and post-lot rework operations
Customized to specific packaging use cases
Master data and package order support
Built-in test and simulation environment
Non-serialized quality vision inspection
Suspend and resume lot selections
Reporting
© 2015 Systech International. Last updated July 2015

18. UNISIGHT – MULTIPLE REGION SOLUTION
Supports multiple regions from a single manufacturing line
Benefits
Meets regional regulatory requirements around the globe
Rapid implementation
Reduce line downtime
Easily add site level
Future proofed compliance
Features
Built-in test and simulation environment
Supports in-lot and post-lot rework operations
Customized to specific packaging use cases
Centralized palletizing
Packaging use cases, pack-by-layer, centralized palletizing
Master data and package order support
Non-serialized quality vision inspection
Suspend and resume lot selections
Reporting
Advanced configuration options
© 2015 Systech International. Last updated July 2015

19. THANK YOU www.SystechOne.com
© 2015 Systech International. Last updated July 2015