TrackTraceIT Inc.’s steps includes -

• Continuous Support of System Integrations EPCIS System Review: Ensure the manufacturer’s EPCIS system is continuously compliant with DSCSA standards and can properly capture and exchange required data. Integration with Current Systems and Partner Systems: Evaluate and integrate the EPCIS system with the manufacturer's existing IT systems (like ERP, WMS, etc.) if not already done, and support partner integrations upstream (Manufacturing Sites / CMOs / 3PL) & downstream (trade-partners).
• Data Management Data Flow Mapping: Map out the flow of EPCIS data between upstream and downstream trade partners. Data Validation: Set up processes to validate the accuracy and completeness of EPCIS data. Master Data Management: Ensure master data related to products, locations, and trade partners is standardized, accurate, and updated.
• Trade Partner Collaborations Trade Partner Onboarding: Assist in the onboarding process for new trade partners to ensure smooth data exchange. Data Exchange Protocols: Define and standardize protocols for exchanging EPCIS data with both upstream and downstream trade partners. Partner Compliance Checks: Set up mechanisms to periodically check the compliance of trade partners regarding DSCSA requirements
• Training & Documentation Training Modules: Develop and conduct training sessions for relevant stakeholders within the manufacturer’s organization on EPCIS best practices and DSCSA requirements. Documentation: Create and maintain documentation on processes, data standards, system configurations, and partner integration details.
• Compliance & Auditing Compliance Monitoring: Establish mechanisms to continuously monitor compliance with DSCSA requirements. Audit Preparation: Assist the manufacturer in preparing for any potential FDA or third-party audits related to DSCSA. Issue Resolution: Set up processes to identify and resolve any compliance issues or discrepancies in EPCIS data.
• Testing & Validation System Testing: Perform regular testing of the EPCIS system to ensure it captures, processes, and shares data accurately. Trade Partner Testing: Periodically test EPCIS data exchange with selected trade partners to validate end-to-end data flow and compliance.
• Ongoing Support Technical Support: Provide support for any technical issues or challenges related to EPCIS data management or exchange. Updates & Patches: Stay updated on any changes to DSCSA requirements or EPCIS standards and assist the manufacturer in implementing necessary updates or patches.
• Stakeholder Communication Regular Reporting: Provide regular reports to the manufacturer's leadership on the status, challenges, and achievements related to EPCIS and DSCSA compliance. Feedback Loop: Establish a mechanism for stakeholders to provide feedback on challenges or inefficiencies and take corrective actions.