Future-proofing in the context of serialization and Track & Trace refers to the process of ensuring that the systems, processes, and technologies in place can adapt to future changes in regulations, technology, market demands, and business growth without requiring major overhauls. It is a proactive strategy to maintain the system’s relevance, scalability, and efficiency over time.
You might have been running a serialization system for years, but have you ever had an external opinion on your processes, solution, and architecture? Is it a system for the future? Are you aware of the architecture of the future?
Questions to consider:
IS MY SERIALIZATION SYSTEM READY FOR THE NEXT REGULATORY WAVE?
IS MY INFRASTRUCTURE READY FOR AI, BLOCKCHAIN, AND TOMORROW’S TECH DEMANDS?
DO YOU HAVE A BUSINESS CONTINUITY PROCESS, AND IS IT STILL VALID?
AM I TAPPING REAL-TIME DATA TO SPOT COMPLIANCE THREATS BEFORE THEY ESCALATE?
ARE THE PROCESSES AND PROCEDURES DEFINED DURING DEPLOYMENT FULLY UTILIZED BY THE PEOPLE?
Companies that have already implemented serialization and Track & Trace systems and have been using them for some time should focus on future-proofing their systems. This involves ensuring that the system and its architecture remain compatible with recent technological advancements. It also means verifying that the system's capacity is sufficient to handle future volumes, and that processes are clearly defined and consistently followed.
The future proofing process involves audit on the existing system and processes by following best practices available in the market and provide recommendations. It covers following high level deliverables:
CONDUCT A COMPREHENSIVE AUDIT AND ANALYSIS OF THE CURRENT ARCHITECTURE, ENCOMPASSING ALL SYSTEMS FROM LEVEL 1 TO LEVEL 5.
EVALUATE EXISTING SERIALIZATION PROCESSES TO PINPOINT GAPS AND PROPOSE ACTIONABLE SOLUTIONS.
ASSESS THE QUALITY AND CONSISTENCY OF BARCODES PRINTED ACROSS VARIOUS SITES.
ANALYZE SUPPLY CHAIN PROCESSES TO IDENTIFY INEFFICIENCIES AND OPTIMIZE WORKFLOWS.
What to expect from future proofing:
ENSURES SYSTEM COMPLIANCE
- Regulatory Alignment: Validates compliance with evolving global and regional regulations such as DSCSA, EU FMD, and others.
- Avoid Penalties: Reduces the risk of non-compliance penalties by ensuring adherence to updated mandates.
ENHANCES SYSTEM PERFORMANCE
- Optimized Architecture: Identifies inefficiencies in the existing system architecture and suggests enhancements.
- Improved Scalability: Ensures the system is capable of handling future increases in production volumes and data processing.
- Enhanced Data Accuracy: Reduces errors in serialization, ensuring traceability and reliable product tracking.
IDENTIFIES AND RESOLVES GAPS
- Process Efficiency: Highlights inefficiencies in serialization processes, QR/barcode printing, and data handling.
- Gap Closure: Proposes actionable solutions to address identified weaknesses, ensuring smooth operations.
MITIGATES RISKS
- Duplicate Serial Numbers: Ensures mechanisms are in place to prevent duplicate or conflicting serial numbers in the supply chain.
- Supply Chain Integrity: Strengthens traceability and transparency, reducing the risk of counterfeit products.
SUPPORTS BUSINESS GROWTH
- Future-Ready Systems: Ensures the system is prepared to adapt to technological advancements and market demands.
- Seamless Integration: Improves interoperability with new technologies, systems, or supply chain partners.
COST OPTIMIZATION
- Reduced Downtime: Identifies potential bottlenecks and mitigates risks of system outages or inefficiencies.
- Efficient Resource Allocation: Optimizes resource use across production, IT, and supply chain processes.
BUILDS STAKEHOLDER CONFIDENCE
- Customer Assurance: Enhances customer trust by ensuring product authenticity and traceability.
- Regulatory Trust: Demonstrates a proactive approach to compliance and system maintenance.
STRENGTHENS DECISION-MAKING
- Data-Driven Insights: Provides valuable analytics and insights to inform strategic decisions.
- Performance Metrics: Offers a clear view of system health, enabling targeted improvements.
YOU WILL GET ALL THE FOLLOWING DOCUMENTATION AND ALL MATERIALS WILL BE PRESENTED!
CONDUCTING AN AUDIT OF SERIALIZATION AND TRACK & TRACE SYSTEMS ENSURES LONG-TERM OPERATIONAL EXCELLENCE, COMPLIANCE, AND COMPETITIVE ADVANTAGE IN A RAPIDLY CHANGING INDUSTRY.
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1. Audit Report
2. Compliance Assessment Report |
5. Data Integrity and Security Assessment 11. Supporting Documentation |
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Estimated Timeline:*
Workshops:
- 2 days for the production site
- 2 days for IT
- 3 days for As-Is analysis and stakeholder meetings
Analysis & Review:
- 3 days to finalize and review
Total: 10 days
*The estimate is based on 1 production site and a full end-to-end IT architecture. Additional time may be required: +3 days per extra production site, +5 days if supply chain integration is included.
Why Choose 3KEYS:
Proven Expertise:
- Extensive experience in implementing and auditing serialization and Track & Trace systems across diverse industries.
- Deep knowledge and experience in working with Level 1 to Level 5 Solution providers.
- Solution agnostic audit approach
- Deep knowledge of global regulations (e.g., DSCSA, EU FMD) and industry standards (e.g., GS1).
Comprehensive Approach:
- Expertise in evaluating all system levels (Level 1 to Level 5), from production line equipment to enterprise and supply chain systems.
- Holistic audits covering architecture, processes, data integrity, compliance, and security.
Future-Ready Focus:
- Emphasis on future-proofing systems to ensure scalability, technological compatibility, and long-term compliance.
- Guidance on adopting cutting-edge technologies like blockchain, Artificial Intelligence and advanced analytics to enhance system performance.
- Experience in defining the architecture for the future with latest available technologies and solutions.