The Systech “Serialized by November” Rapid Compliance Program provides the shortest path for companies to be DSCSA compliant in 90 days.
Systech is currently onboarding customers from now until August 1 under this program.
Our Program includes:
Multi-level serialization
Site and line management configuration
A built-in foundation for future lines, documentation
Factory Acceptance Testing (FAT)
Ready for Site Acceptance Testing (SAT)
2. This webinar is
intended to be
interactive
Information contained in
this webinar is current as
of February 2017
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BEFORE WE DIVE IN…
WEBINAR SERIES
3. Stephen Lisa
DIRECTOR, PRODUCT MANAGEMENT
FOR SYSTECH INTERNATIONAL
Stephen’s 20 years of experience at Systech include product management, software
development, customer deployment and customer support. Mr. Lisa has performed
extensive product definition and development activities and worked with customers on
serialization packaging deployments and the original serialization pilots. Other roles
performed during his years include conducting analysis design and architecture
meetings with customers, defining requirements for packaging, serialization and
enterprise applications, specifications for hardware platforms, management of the
engineering team, and collaboration on Systech’s product roadmap.
PRESENTER
7. WHAT BUSINESS CHALLENGES ARE WE TRYING TO SOLVE?
Comply with global regulations
Confirm market access
Avoid quarantine
Line readiness
Limit downtime
Ensure proper product handling
Exception handling
In-lot
Post-lot
Supply chain readiness
Data access and data exchange
Trade partners
9. DATA REQUIREMENTS DIFFER PER MARKET
Know the data regulations that pertain to each market. Different markets pose
different requirements.
• Some markets require product master data to be reported separately.
• Some markets require multiple reporting requirements.
• Some markets require barcodes with different data combinations encoded in them in
addition to specific human-readable data.
• Some markets indicate the manufacturer is solely responsible.
• Some markets require inclusion of a National Reimbursement Number or application
of labels for similar purposes.
• Some markets have influential stakeholders which are impacting guidelines.
• Some markets define events differently (ie: decommissioning)
10. CODING VS REPORTING
Serialization Coding
GS1 widely adopted (01)(21)(17)(10)….
Barcoding quality spec standards
Data carriers widely adopted (2D, 1D, QR)
Printers and inspection equipment at generation 3, 4, 5 and beyond
Compliance Reporting
Reporting output requirements are vague…..
Hub model vs chain of custody model
The influence of wholesalers
What to report and when?
ENSURE YOU HAVE THE DATA READY NOW FOR WHATEVER IS COMING!!!!
11. WHERE DO I EVEN START?
? ? ?
Food for Thought
What resources do I need?
Which markets do I deliver product to?
What lines at what sites run which products?
What is the best deployment model?
Do I have the data model to support compliance?
What is the timeline?
How much does line downtime cost?
What happens if……?
15. RAPID COMPLIANCE CHECKLIST
What markets am I selling to?
What sites and lines are in Phase 1?
What are my “as-is” line workflows?
What are my current print/labeling formats?
Are all the stakeholders for serialization involved?
Are we controlling project scope / scope creep?
Where am I required to send my serialized data?
16. DEFINE ALIGN DIVIDE DEPLOY
RAPID COMPLIANCE BEST PRACTICES
Phase 1 Scope Stakeholders Parallel Tasks Start Up
17. One Partner responsible for
• Site Serialization Infrastructure
• Standard Catalog Offerings
• Total Project Management
• Delivering Configured Line Solutions
• Expert On-Site Services
• Post Implementation Support
Rapid Deployment
• Pre-engineered packaging stations
• Pre-defined workflows
• Regional installation services network
SERIALIZATION SIMPLIFIED
PREPACKAGED SOLUTIONS
Experienced manufacturers working together to bring
serialization ready packaging machines to the market
Machines are serialization ready with all interfaces and
workflows defined and tested
18. SUMMARY
ACHIEVE COMPLIANCE
Numerous evolving regional regulations
KNOW YOUR DEPLOYMENT
Rapid deployments can only occur when the parts are aligned
SYSTEMS UNITE
Multiple vendors and interfaces
DATA IS KING
Gather data and provide value
BE READY FOR ANYTHING
Happy path vs unhappy path
KNOW AND MEET MARKET REGULATIONS
IDENTIFY THE TEAMS,
KNOW THE MODEL, EXECUTE
STANDARDIZE YOUR SOLUTIONS
ENSURE YOUR BRAND IS PROTECTED
EXCEPTION HANDLING, BE AWARE
19. READY. SET. GET SERIALIZED BY NOVEMBER 2017.
The Systech “Serialized by November”
Rapid Compliance Program provides the
shortest path for companies to be DSCSA
compliant in 90 days.
Systech is currently onboarding customers
from now until August 1
under this program.
Our Program includes:
• Multi-level serialization
• Site and line management configuration
• A built-in foundation for future lines, documentation
• Factory Acceptance Testing (FAT)
• Ready for Site Acceptance Testing (SAT)
20. Please submit your questions
Webinar recording and supplemental booklet will be sent to you
within 48 hours
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