<div data-id="1891" data-import-id="" data-scenario-id="" class="cht-ai col-sm-12 "><span class="ai-assist-link"><i class="ai-agent-icon" style=""></i></span><h1 id="globalserializationandanticounterfeitplatformcomplianceexecutionplan">Global Serialization and Anti-Counterfeit Platform: Compliance Execution Plan</h1> <h2 id="executivesummary">Executive Summary</h2> <p>This comprehensive compliance execution plan addresses the implementation of a global serialization and anti-counterfeit platform for specialty biologics distribution across multiple regulatory jurisdictions. With the FDA DSCSA requirements fully enforced as of November 27, 2024, EU FMD continuing with mature implementation, and evolving requirements in India and China, this platform must achieve seamless integration across diverse regulatory frameworks while maintaining operational excellence.</p> <p>The project encompasses critical elements including multi-jurisdictional regulatory compliance (FDA DSCSA, EU FMD, India/China track-and-trace), sophisticated IT system validation, comprehensive vendor onboarding processes, real-time verification capabilities, robust risk management frameworks, and comprehensive operational procedures. The platform architecture must support unique identifier management, interoperable data exchange, authentication verification, and regulatory reporting across all target markets.</p> <p>Strategic success requires coordinated implementation across regulatory domains, technology infrastructure, operational processes, and vendor partnerships. The execution plan prioritizes regulatory compliance milestones, system validation gates, and operational readiness while maintaining specialty biologics distribution integrity throughout the transformation process.</p> <h2 id="workbreakdownstructure">Work Breakdown Structure</h2> <div data-id="1891" class="table-wrap"><div class="top-row"><div class="pull-right"><a href="planner/csv/1891" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div><div class="table-wrap-in"><table> <thead> <tr> <th id="wbs">WBS</th> <th id="activity_name">Activity Name</th> <th id="activity_type">Activity Type</th> <th id="duration">Duration</th> <th id="start_date">Start Date</th> <th id="end_date">End Date</th> </tr> </thead> <tbody> <tr> <td>GSAC</td> <td>Global Serialization Anti-Counterfeit Platform Implementation</td> <td>Draft</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1</td> <td>Program Initiation and Planning</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1</td> <td>Stakeholder Alignment and Charter Development</td> <td>Task</td> <td>15</td> <td>2025-01-01</td> <td>2025-01-21</td> </tr> <tr> <td>1.2</td> <td>Cross-Jurisdictional Regulatory Assessment</td> <td>Task</td> <td>20</td> <td>2025-01-01</td> <td>2025-01-28</td> </tr> <tr> <td>1.3</td> <td>Platform Architecture Design and Approval</td> <td>Task</td> <td>25</td> <td>2025-01-22</td> <td>2025-02-25</td> </tr> <tr> <td>1.4</td> <td>Program Management Office Establishment</td> <td>Task</td> <td>10</td> <td>2025-01-22</td> <td>2025-02-04</td> </tr> <tr> <td>1.5</td> <td>Executive Steering Committee Formation</td> <td>Milestone</td> <td>0</td> <td>2025-02-04</td> <td>2025-02-04</td> </tr> <tr> <td>2</td> <td>Regulatory Compliance Framework Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1</td> <td>FDA DSCSA Compliance Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1.1</td> <td>DSCSA Enhanced Track and Trace Requirements Analysis</td> <td>Task</td> <td>12</td> <td>2025-02-05</td> <td>2025-02-20</td> </tr> <tr> <td>2.1.2</td> <td>Interoperable System Design for FDA Compliance</td> <td>Task</td> <td>18</td> <td>2025-02-21</td> <td>2025-03-18</td> </tr> <tr> <td>2.1.3</td> <td>Product Identifier and Data Standards Implementation</td> <td>Task</td> <td>22</td> <td>2025-03-19</td> <td>2025-04-17</td> </tr> <tr> <td>2.1.4</td> <td>Verification and Investigation Process Development</td> <td>Task</td> <td>15</td> <td>2025-04-18</td> <td>2025-05-08</td> </tr> <tr> <td>2.1.5</td> <td>FDA DSCSA Compliance Validation</td> <td>Milestone</td> <td>0</td> <td>2025-05-08</td> <td>2025-05-08</td> </tr> <tr> <td>2.2</td> <td>EU FMD Compliance Integration</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.2.1</td> <td>EU Safety Features and Serialization Assessment</td> <td>Task</td> <td>10</td> <td>2025-02-05</td> <td>2025-02-18</td> </tr> <tr> <td>2.2.2</td> <td>European Hub Integration Architecture</td> <td>Task</td> <td>20</td> <td>2025-02-19</td> <td>2025-03-18</td> </tr> <tr> <td>2.2.3</td> <td>National Repository Connection Development</td> <td>Task</td> <td>25</td> <td>2025-03-19</td> <td>2025-04-22</td> </tr> <tr> <td>2.2.4</td> <td>Anti-Tampering Device Integration</td> <td>Task</td> <td>12</td> <td>2025-04-23</td> <td>2025-05-08</td> </tr> <tr> <td>2.2.5</td> <td>EU FMD System Testing and Validation</td> <td>Task</td> <td>15</td> <td>2025-05-09</td> <td>2025-05-29</td> </tr> <tr> <td>2.2.6</td> <td>EU Compliance Certification</td> <td>Milestone</td> <td>0</td> <td>2025-05-29</td> <td>2025-05-29</td> </tr> <tr> <td>2.3</td> <td>India Track-and-Trace Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.3.1</td> <td>India Pharmaceutical Serialization Requirements Analysis</td> <td>Task</td> <td>14</td> <td>2025-02-26</td> <td>2025-03-17</td> </tr> <tr> <td>2.3.2</td> <td>CDSCO Compliance Framework Development</td> <td>Task</td> <td>18</td> <td>2025-03-18</td> <td>2025-04-10</td> </tr> <tr> <td>2.3.3</td> <td>Indian System Integration Architecture</td> <td>Task</td> <td>20</td> <td>2025-04-11</td> <td>2025-05-07</td> </tr> <tr> <td>2.3.4</td> <td>Data Format and Reporting Compliance</td> <td>Task</td> <td>12</td> <td>2025-05-08</td> <td>2025-05-23</td> </tr> <tr> <td>2.3.5</td> <td>India Regulatory Authority Integration Testing</td> <td>Task</td> <td>10</td> <td>2025-05-24</td> <td>2025-06-05</td> </tr> <tr> <td>2.3.6</td> <td>India Compliance Approval</td> <td>Milestone</td> <td>0</td> <td>2025-06-05</td> <td>2025-06-05</td> </tr> <tr> <td>2.4</td> <td>China Serialization System Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.4.1</td> <td>China NMPA Serialization Requirements Assessment</td> <td>Task</td> <td>16</td> <td>2025-02-26</td> <td>2025-03-19</td> </tr> <tr> <td>2.4.2</td> <td>China Drug Code System Integration</td> <td>Task</td> <td>22</td> <td>2025-03-20</td> <td>2025-04-18</td> </tr> <tr> <td>2.4.3</td> <td>Local Manufacturing Compliance Framework</td> <td>Task</td> <td>18</td> <td>2025-04-19</td> <td>2025-05-12</td> </tr> <tr> <td>2.4.4</td> <td>Chinese Regulatory Reporting System Development</td> <td>Task</td> <td>15</td> <td>2025-05-13</td> <td>2025-06-02</td> </tr> <tr> <td>2.4.5</td> <td>China System Validation and Testing</td> <td>Task</td> <td>12</td> <td>2025-06-03</td> <td>2025-06-18</td> </tr> <tr> <td>2.4.6</td> <td>China Regulatory Compliance Certification</td> <td>Milestone</td> <td>0</td> <td>2025-06-18</td> <td>2025-06-18</td> </tr> <tr> <td>3</td> <td>IT System Architecture and Integration</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1</td> <td>Core Platform Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1.1</td> <td>Serialization Database Architecture Design</td> <td>Task</td> <td>20</td> <td>2025-02-26</td> <td>2025-03-25</td> </tr> <tr> <td>3.1.2</td> <td>Multi-Jurisdictional Data Model Development</td> <td>Task</td> <td>25</td> <td>2025-03-26</td> <td>2025-04-29</td> </tr> <tr> <td>3.1.3</td> <td>Real-Time Verification Engine Development</td> <td>Task</td> <td>30</td> <td>2025-04-30</td> <td>2025-06-11</td> </tr> <tr> <td>3.1.4</td> <td>Cross-Border Data Exchange Protocol Implementation</td> <td>Task</td> <td>18</td> <td>2025-06-12</td> <td>2025-07-07</td> </tr> <tr> <td>3.1.5</td> <td>Core Platform Integration Testing</td> <td>Task</td> <td>15</td> <td>2025-07-08</td> <td>2025-07-28</td> </tr> <tr> <td>3.1.6</td> <td>Platform Architecture Approval</td> <td>Milestone</td> <td>0</td> <td>2025-07-28</td> <td>2025-07-28</td> </tr> <tr> <td>3.2</td> <td>Regulatory System Integrations</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.2.1</td> <td>FDA DSCSA System API Development</td> <td>Task</td> <td>22</td> <td>2025-05-09</td> <td>2025-06-09</td> </tr> <tr> <td>3.2.2</td> <td>EU European Hub Connection Implementation</td> <td>Task</td> <td>18</td> <td>2025-06-10</td> <td>2025-07-03</td> </tr> <tr> <td>3.2.3</td> <td>India CDSCO System Integration</td> <td>Task</td> <td>20</td> <td>2025-07-04</td> <td>2025-07-31</td> </tr> <tr> <td>3.2.4</td> <td>China NMPA System Connection Development</td> <td>Task</td> <td>16</td> <td>2025-08-01</td> <td>2025-08-21</td> </tr> <tr> <td>3.2.5</td> <td>Multi-Regulatory Reporting Dashboard</td> <td>Task</td> <td>12</td> <td>2025-08-22</td> <td>2025-09-08</td> </tr> <tr> <td>3.2.6</td> <td>Regulatory Integration Validation</td> <td>Milestone</td> <td>0</td> <td>2025-09-08</td> <td>2025-09-08</td> </tr> <tr> <td>3.3</td> <td>Enterprise System Integration</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.3.1</td> <td>ERP System Integration Architecture</td> <td>Task</td> <td>15</td> <td>2025-07-29</td> <td>2025-08-18</td> </tr> <tr> <td>3.3.2</td> <td>Warehouse Management System Connection</td> <td>Task</td> <td>18</td> <td>2025-08-19</td> <td>2025-09-11</td> </tr> <tr> <td>3.3.3</td> <td>Supply Chain Management Integration</td> <td>Task</td> <td>20</td> <td>2025-09-12</td> <td>2025-10-08</td> </tr> <tr> <td>3.3.4</td> <td>Quality Management System Linkage</td> <td>Task</td> <td>12</td> <td>2025-10-09</td> <td>2025-10-24</td> </tr> <tr> <td>3.3.5</td> <td>Enterprise Integration Testing</td> <td>Task</td> <td>10</td> <td>2025-10-25</td> <td>2025-11-07</td> </tr> <tr> <td>3.3.6</td> <td>Enterprise System Validation Complete</td> <td>Milestone</td> <td>0</td> <td>2025-11-07</td> <td>2025-11-07</td> </tr> <tr> <td>4</td> <td>System Validation and Computer System Validation (CSV)</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1</td> <td>Validation Planning and Documentation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1.1</td> <td>Computer System Validation Master Plan Development</td> <td>Task</td> <td>12</td> <td>2025-07-29</td> <td>2025-08-13</td> </tr> <tr> <td>4.1.2</td> <td>User Requirements Specification (URS) Creation</td> <td>Task</td> <td>15</td> <td>2025-08-14</td> <td>2025-09-03</td> </tr> <tr> <td>4.1.3</td> <td>Functional Requirements Specification (FRS) Development</td> <td>Task</td> <td>18</td> <td>2025-09-04</td> <td>2025-09-29</td> </tr> <tr> <td>4.1.4</td> <td>Design Qualification (DQ) Documentation</td> <td>Task</td> <td>10</td> <td>2025-09-30</td> <td>2025-10-13</td> </tr> <tr> <td>4.1.5</td> <td>Validation Protocols Development</td> <td>Task</td> <td>20</td> <td>2025-10-14</td> <td>2025-11-10</td> </tr> <tr> <td>4.1.6</td> <td>Validation Documentation Approval</td> <td>Decision</td> <td>0</td> <td>2025-11-10</td> <td>2025-11-10</td> </tr> <tr> <td>4.2</td> <td>Installation and Operational Qualification</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.2.1</td> <td>Installation Qualification (IQ) Execution</td> <td>Task</td> <td>8</td> <td>2025-11-11</td> <td>2025-11-20</td> </tr> <tr> <td>4.2.2</td> <td>Operational Qualification (OQ) Testing</td> <td>Task</td> <td>15</td> <td>2025-11-21</td> <td>2025-12-11</td> </tr> <tr> <td>4.2.3</td> <td>System Security Validation</td> <td>Task</td> <td>10</td> <td>2025-12-12</td> <td>2025-12-25</td> </tr> <tr> <td>4.2.4</td> <td>Data Integrity Validation</td> <td>Task</td> <td>12</td> <td>2025-12-26</td> <td>2026-01-12</td> </tr> <tr> <td>4.2.5</td> <td>Audit Trail and Electronic Records Validation</td> <td>Task</td> <td>8</td> <td>2026-01-13</td> <td>2026-01-22</td> </tr> <tr> <td>4.2.6</td> <td>IQ/OQ Completion Milestone</td> <td>Milestone</td> <td>0</td> <td>2026-01-22</td> <td>2026-01-22</td> </tr> <tr> <td>4.3</td> <td>Performance Qualification and Go-Live</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.3.1</td> <td>Performance Qualification (PQ) Execution</td> <td>Task</td> <td>20</td> <td>2026-01-23</td> <td>2026-02-19</td> </tr> <tr> <td>4.3.2</td> <td>Multi-Jurisdictional Compliance Testing</td> <td>Task</td> <td>15</td> <td>2026-02-20</td> <td>2026-03-12</td> </tr> <tr> <td>4.3.3</td> <td>User Acceptance Testing (UAT)</td> <td>Task</td> <td>12</td> <td>2026-03-13</td> <td>2026-03-30</td> </tr> <tr> <td>4.3.4</td> <td>Production Readiness Assessment</td> <td>Task</td> <td>5</td> <td>2026-03-31</td> <td>2026-04-06</td> </tr> <tr> <td>4.3.5</td> <td>System Validation Report (SVR) Approval</td> <td>Decision</td> <td>0</td> <td>2026-04-07</td> <td>2026-04-07</td> </tr> <tr> <td>4.3.6</td> <td>CSV Complete and System Approved</td> <td>Milestone</td> <td>0</td> <td>2026-04-07</td> <td>2026-04-07</td> </tr> <tr> <td>5</td> <td>Vendor Onboarding and Partnership Management</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1</td> <td>Vendor Assessment and Selection</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1.1</td> <td>Serialization Technology Vendor Evaluation</td> <td>Task</td> <td>18</td> <td>2025-03-26</td> <td>2025-04-18</td> </tr> <tr> <td>5.1.2</td> <td>Packaging Line Equipment Supplier Assessment</td> <td>Task</td> <td>15</td> <td>2025-04-19</td> <td>2025-05-09</td> </tr> <tr> <td>5.1.3</td> <td>Third-Party Logistics Provider Qualification</td> <td>Task</td> <td>20</td> <td>2025-05-10</td> <td>2025-06-05</td> </tr> <tr> <td>5.1.4</td> <td>Software Integration Partner Selection</td> <td>Task</td> <td>12</td> <td>2025-06-06</td> <td>2025-06-23</td> </tr> <tr> <td>5.1.5</td> <td>Contract Manufacturing Organization (CMO) Onboarding</td> <td>Task</td> <td>25</td> <td>2025-06-24</td> <td>2025-07-28</td> </tr> <tr> <td>5.1.6</td> <td>Vendor Selection Committee Decision</td> <td>Decision</td> <td>0</td> <td>2025-07-28</td> <td>2025-07-28</td> </tr> <tr> <td>5.2</td> <td>Vendor Integration and Qualification</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.2.1</td> <td>Vendor Data Exchange Protocol Development</td> <td>Task</td> <td>16</td> <td>2025-07-29</td> <td>2025-08-19</td> </tr> <tr> <td>5.2.2</td> <td>Supplier Quality Agreement Development</td> <td>Task</td> <td>12</td> <td>2025-08-20</td> <td>2025-09-04</td> </tr> <tr> <td>5.2.3</td> <td>Vendor System Integration Testing</td> <td>Task</td> <td>18</td> <td>2025-09-05</td> <td>2025-09-30</td> </tr> <tr> <td>5.2.4</td> <td>Supply Chain Partner Qualification</td> <td>Task</td> <td>15</td> <td>2025-10-01</td> <td>2025-10-21</td> </tr> <tr> <td>5.2.5</td> <td>Vendor Performance Monitoring System Setup</td> <td>Task</td> <td>10</td> <td>2025-10-22</td> <td>2025-11-04</td> </tr> <tr> <td>5.2.6</td> <td>Vendor Network Operational</td> <td>Milestone</td> <td>0</td> <td>2025-11-04</td> <td>2025-11-04</td> </tr> <tr> <td>5.3</td> <td>Ongoing Vendor Management</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.3.1</td> <td>Vendor Audit and Compliance Program Development</td> <td>Task</td> <td>8</td> <td>2025-11-05</td> <td>2025-11-14</td> </tr> <tr> <td>5.3.2</td> <td>Performance Metrics and KPI Framework</td> <td>Task</td> <td>6</td> <td>2025-11-15</td> <td>2025-11-22</td> </tr> <tr> <td>5.3.3</td> <td>Vendor Risk Assessment Procedures</td> <td>Task</td> <td>10</td> <td>2025-11-23</td> <td>2025-12-06</td> </tr> <tr> <td>5.3.4</td> <td>Continuous Improvement Process Implementation</td> <td>Task</td> <td>8</td> <td>2025-12-07</td> <td>2025-12-18</td> </tr> <tr> <td>5.3.5</td> <td>Vendor Management System Go-Live</td> <td>Milestone</td> <td>0</td> <td>2025-12-18</td> <td>2025-12-18</td> </tr> <tr> <td>6</td> <td>Risk Management and Security Framework</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.1</td> <td>Risk Assessment and Register Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.1.1</td> <td>Comprehensive Risk Identification Workshop</td> <td>Task</td> <td>5</td> <td>2025-04-08</td> <td>2025-04-14</td> </tr> <tr> <td>6.1.2</td> <td>Data Security Risk Assessment</td> <td>Task</td> <td>12</td> <td>2025-04-15</td> <td>2025-05-01</td> </tr> <tr> <td>6.1.3</td> <td>Supply Chain Disruption Risk Analysis</td> <td>Task</td> <td>10</td> <td>2025-05-02</td> <td>2025-05-15</td> </tr> <tr> <td>6.1.4</td> <td>Regulatory Compliance Risk Evaluation</td> <td>Task</td> <td>8</td> <td>2025-05-16</td> <td>2025-05-27</td> </tr> <tr> <td>6.1.5</td> <td>Technology Infrastructure Risk Assessment</td> <td>Task</td> <td>15</td> <td>2025-05-28</td> <td>2025-06-17</td> </tr> <tr> <td>6.1.6</td> <td>Risk Register and Mitigation Plan Completion</td> <td>Milestone</td> <td>0</td> <td>2025-06-17</td> <td>2025-06-17</td> </tr> <tr> <td>6.2</td> <td>Cybersecurity and Data Protection Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.2.1</td> <td>Cybersecurity Framework Design</td> <td>Task</td> <td>18</td> <td>2025-06-18</td> <td>2025-07-11</td> </tr> <tr> <td>6.2.2</td> <td>Data Encryption and Access Control Implementation</td> <td>Task</td> <td>20</td> <td>2025-07-12</td> <td>2025-08-07</td> </tr> <tr> <td>6.2.3</td> <td>Multi-Jurisdictional Data Privacy Compliance</td> <td>Task</td> <td>15</td> <td>2025-08-08</td> <td>2025-08-28</td> </tr> <tr> <td>6.2.4</td> <td>Security Monitoring and Incident Response System</td> <td>Task</td> <td>12</td> <td>2025-08-29</td> <td>2025-09-15</td> </tr> <tr> <td>6.2.5</td> <td>Penetration Testing and Vulnerability Assessment</td> <td>Task</td> <td>8</td> <td>2025-09-16</td> <td>2025-09-25</td> </tr> <tr> <td>6.2.6</td> <td>Security Certification and Approval</td> <td>Decision</td> <td>0</td> <td>2025-09-25</td> <td>2025-09-25</td> </tr> <tr> <td>6.3</td> <td>Business Continuity and Disaster Recovery</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.3.1</td> <td>Business Impact Analysis</td> <td>Task</td> <td>10</td> <td>2025-09-26</td> <td>2025-10-09</td> </tr> <tr> <td>6.3.2</td> <td>Disaster Recovery Plan Development</td> <td>Task</td> <td>15</td> <td>2025-10-10</td> <td>2025-10-30</td> </tr> <tr> <td>6.3.3</td> <td>Backup and Recovery System Implementation</td> <td>Task</td> <td>18</td> <td>2025-10-31</td> <td>2025-11-25</td> </tr> <tr> <td>6.3.4</td> <td>Business Continuity Testing</td> <td>Task</td> <td>8</td> <td>2025-11-26</td> <td>2025-12-05</td> </tr> <tr> <td>6.3.5</td> <td>Emergency Response Procedures Validation</td> <td>Task</td> <td>5</td> <td>2025-12-06</td> <td>2025-12-12</td> </tr> <tr> <td>6.3.6</td> <td>Business Continuity Framework Approved</td> <td>Milestone</td> <td>0</td> <td>2025-12-12</td> <td>2025-12-12</td> </tr> <tr> <td>7</td> <td>Real-Time Verification and Authentication Systems</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>7.1</td> <td>Verification System Architecture</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>7.1.1</td> <td>Real-Time Verification Requirements Analysis</td> <td>Task</td> <td>12</td> <td>2025-06-12</td> <td>2025-06-27</td> </tr> <tr> <td>7.1.2</td> <td>Multi-Jurisdictional Verification Protocol Design</td> <td>Task</td> <td>18</td> <td>2025-06-28</td> <td>2025-07-23</td> </tr> <tr> <td>7.1.3</td> <td>Authentication Algorithm Development</td> <td>Task</td> <td>22</td> <td>2025-07-24</td> <td>2025-08-22</td> </tr> <tr> <td>7.1.4</td> <td>Product Authentication Database Architecture</td> <td>Task</td> <td>15</td> <td>2025-08-23</td> <td>2025-09-12</td> </tr> <tr> <td>7.1.5</td> <td>Verification System Integration Framework</td> <td>Task</td> <td>20</td> <td>2025-09-13</td> <td>2025-10-08</td> </tr> <tr> <td>7.1.6</td> <td>Verification Architecture Approval</td> <td>Decision</td> <td>0</td> <td>2025-10-08</td> <td>2025-10-08</td> </tr> <tr> <td>7.2</td> <td>Authentication Technology Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>7.2.1</td> <td>Barcode and DataMatrix Scanning Integration</td> <td>Task</td> <td>16</td> <td>2025-10-09</td> <td>2025-10-30</td> </tr> <tr> <td>7.2.2</td> <td>RFID and NFC Technology Integration</td> <td>Task</td> <td>18</td> <td>2025-10-31</td> <td>2025-11-25</td> </tr> <tr> <td>7.2.3</td> <td>Blockchain Authentication Layer Development</td> <td>Task</td> <td>25</td> <td>2025-11-26</td> <td>2025-12-30</td> </tr> <tr> <td>7.2.4</td> <td>Mobile Verification Application Development</td> <td>Task</td> <td>20</td> <td>2025-12-31</td> <td>2026-01-27</td> </tr> <tr> <td>7.2.5</td> <td>Authentication Technology Testing</td> <td>Task</td> <td>12</td> <td>2026-01-28</td> <td>2026-02-12</td> </tr> <tr> <td>7.2.6</td> <td>Authentication System Operational</td> <td>Milestone</td> <td>0</td> <td>2026-02-12</td> <td>2026-02-12</td> </tr> <tr> <td>7.3</td> <td>Real-Time Monitoring and Response</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>7.3.1</td> <td>Real-Time Dashboard Development</td> <td>Task</td> <td>15</td> <td>2026-02-13</td> <td>2026-03-05</td> </tr> <tr> <td>7.3.2</td> <td>Alert and Notification System Implementation</td> <td>Task</td> <td>12</td> <td>2026-03-06</td> <td>2026-03-23</td> </tr> <tr> <td>7.3.3</td> <td>Suspicious Activity Detection Algorithms</td> <td>Task</td> <td>18</td> <td>2026-03-24</td> <td>2026-04-16</td> </tr> <tr> <td>7.3.4</td> <td>Investigation and Response Workflow Development</td> <td>Task</td> <td>10</td> <td>2026-04-17</td> <td>2026-04-30</td> </tr> <tr> <td>7.3.5</td> <td>Monitoring System Integration Testing</td> <td>Task</td> <td>8</td> <td>2026-05-01</td> <td>2026-05-12</td> </tr> <tr> <td>7.3.6</td> <td>Real-Time Verification System Go-Live</td> <td>Milestone</td> <td>0</td> <td>2026-05-12</td> <td>2026-05-12</td> </tr> <tr> <td>8</td> <td>Operational Procedures and SOP Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>8.1</td> <td>Core Operational Procedures</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>8.1.1</td> <td>Serialization Process Standard Operating Procedures</td> <td>Task</td> <td>15</td> <td>2025-11-05</td> <td>2025-11-25</td> </tr> <tr> <td>8.1.2</td> <td>Product Verification and Investigation SOPs</td> <td>Task</td> <td>12</td> <td>2025-11-26</td> <td>2025-12-11</td> </tr> <tr> <td>8.1.3</td> <td>Data Management and Reporting Procedures</td> <td>Task</td> <td>18</td> <td>2025-12-12</td> <td>2026-01-07</td> </tr> <tr> <td>8.1.4</td> <td>Quality Control and Compliance Monitoring SOPs</td> <td>Task</td> <td>10</td> <td>2026-01-08</td> <td>2026-01-21</td> </tr> <tr> <td>8.1.5</td> <td>Exception Handling and Deviation Management</td> <td>Task</td> <td>8</td> <td>2026-01-22</td> <td>2026-01-31</td> </tr> <tr> <td>8.1.6</td> <td>Core SOP Library Completed</td> <td>Milestone</td> <td>0</td> <td>2026-01-31</td> <td>2026-01-31</td> </tr> <tr> <td>8.2</td> <td>Multi-Jurisdictional Compliance Procedures</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>8.2.1</td> <td>FDA DSCSA Compliance Operating Procedures</td> <td>Task</td> <td>12</td> <td>2026-02-01</td> <td>2026-02-16</td> </tr> <tr> <td>8.2.2</td> <td>EU FMD Operational Compliance Procedures</td> <td>Task</td> <td>10</td> <td>2026-02-17</td> <td>2026-02-28</td> </tr> <tr> <td>8.2.3</td> <td>India Regulatory Compliance SOPs</td> <td>Task</td> <td>8</td> <td>2026-03-01</td> <td>2026-03-12</td> </tr> <tr> <td>8.2.4</td> <td>China Regulatory Procedures and Documentation</td> <td>Task</td> <td>10</td> <td>2026-03-13</td> <td>2026-03-26</td> </tr> <tr> <td>8.2.5</td> <td>Cross-Border Compliance Coordination Procedures</td> <td>Task</td> <td>6</td> <td>2026-03-27</td> <td>2026-04-03</td> </tr> <tr> <td>8.2.6</td> <td>Regulatory Compliance SOP Suite Complete</td> <td>Milestone</td> <td>0</td> <td>2026-04-03</td> <td>2026-04-03</td> </tr> <tr> <td>8.3</td> <td>Training and Change Management</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>8.3.1</td> <td>Training Program Development and Materials Creation</td> <td>Task</td> <td>20</td> <td>2026-02-13</td> <td>2026-03-12</td> </tr> <tr> <td>8.3.2</td> <td>User Training and Competency Assessment</td> <td>Task</td> <td>15</td> <td>2026-03-13</td> <td>2026-04-02</td> </tr> <tr> <td>8.3.3</td> <td>Change Management and Communication Strategy</td> <td>Task</td> <td>12</td> <td>2026-04-03</td> <td>2026-04-18</td> </tr> <tr> <td>8.3.4</td> <td>Ongoing Training and Support System Implementation</td> <td>Task</td> <td>8</td> <td>2026-04-19</td> <td>2026-04-30</td> </tr> <tr> <td>8.3.5</td> <td>Training Effectiveness Assessment</td> <td>Task</td> <td>5</td> <td>2026-05-01</td> <td>2026-05-07</td> </tr> <tr> <td>8.3.6</td> <td>Training and Change Management Complete</td> <td>Milestone</td> <td>0</td> <td>2026-05-07</td> <td>2026-05-07</td> </tr> <tr> <td>9</td> <td>System Testing and Pilot Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>9.1</td> <td>Comprehensive System Testing</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>9.1.1</td> <td>Integration Testing Across All Jurisdictions</td> <td>Task</td> <td>20</td> <td>2026-04-08</td> <td>2026-05-05</td> </tr> <tr> <td>9.1.2</td> <td>End-to-End Process Testing</td> <td>Task</td> <td>15</td> <td>2026-05-06</td> <td>2026-05-26</td> </tr> <tr> <td>9.1.3</td> <td>Performance and Load Testing</td> <td>Task</td> <td>12</td> <td>2026-05-27</td> <td>2026-06-11</td> </tr> <tr> <td>9.1.4</td> <td>Security and Penetration Testing</td> <td>Task</td> <td>10</td> <td>2026-06-12</td> <td>2026-06-25</td> </tr> <tr> <td>9.1.5</td> <td>Regulatory Compliance Testing</td> <td>Task</td> <td>8</td> <td>2026-06-26</td> <td>2026-07-07</td> </tr> <tr> <td>9.1.6</td> <td>System Testing Completion</td> <td>Milestone</td> <td>0</td> <td>2026-07-07</td> <td>2026-07-07</td> </tr> <tr> <td>9.2</td> <td>Pilot Program Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>9.2.1</td> <td>Pilot Site Selection and Preparation</td> <td>Task</td> <td>10</td> <td>2026-07-08</td> <td>2026-07-21</td> </tr> <tr> <td>9.2.2</td> <td>Limited Product Line Pilot Launch</td> <td>Task</td> <td>15</td> <td>2026-07-22</td> <td>2026-08-11</td> </tr> <tr> <td>9.2.3</td> <td>Pilot Performance Monitoring and Analysis</td> <td>Task</td> <td>20</td> <td>2026-08-12</td> <td>2026-09-08</td> </tr> <tr> <td>9.2.4</td> <td>Issue Resolution and System Optimization</td> <td>Task</td> <td>12</td> <td>2026-09-09</td> <td>2026-09-24</td> </tr> <tr> <td>9.2.5</td> <td>Pilot Success Validation</td> <td>Task</td> <td>8</td> <td>2026-09-25</td> <td>2026-10-06</td> </tr> <tr> <td>9.2.6</td> <td>Pilot Program Successful</td> <td>Decision</td> <td>0</td> <td>2026-10-06</td> <td>2026-10-06</td> </tr> <tr> <td>9.3</td> <td>Production Readiness and Go-Live</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>9.3.1</td> <td>Production Environment Setup and Configuration</td> <td>Task</td> <td>10</td> <td>2026-10-07</td> <td>2026-10-20</td> </tr> <tr> <td>9.3.2</td> <td>Data Migration and System Cutover</td> <td>Task</td> <td>5</td> <td>2026-10-21</td> <td>2026-10-27</td> </tr> <tr> <td>9.3.3</td> <td>Go-Live Support and Monitoring</td> <td>Task</td> <td>10</td> <td>2026-10-28</td> <td>2026-11-10</td> </tr> <tr> <td>9.3.4</td> <td>Post-Implementation Optimization</td> <td>Task</td> <td>15</td> <td>2026-11-11</td> <td>2026-12-01</td> </tr> <tr> <td>9.3.5</td> <td>System Performance Validation</td> <td>Task</td> <td>8</td> <td>2026-12-02</td> <td>2026-12-11</td> </tr> <tr> <td>9.3.6</td> <td>Global Platform Fully Operational</td> <td>Milestone</td> <td>0</td> <td>2026-12-11</td> <td>2026-12-11</td> </tr> <tr> <td>10</td> <td>Post-Implementation and Continuous Improvement</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>10.1</td> <td>Performance Monitoring and Optimization</td> <td>Task</td> <td>30</td> <td>2026-12-12</td> <td>2027-01-26</td> </tr> <tr> <td>10.2</td> <td>Regulatory Compliance Monitoring</td> <td>Task</td> <td>25</td> <td>2027-01-27</td> <td>2027-02-26</td> </tr> <tr> <td>10.3</td> <td>System Enhancement and Upgrade Planning</td> <td>Task</td> <td>20</td> <td>2027-02-27</td> <td>2027-03-24</td> </tr> <tr> <td>10.4</td> <td>Vendor Performance Review and Optimization</td> <td>Task</td> <td>15</td> <td>2027-03-25</td> <td>2027-04-14</td> </tr> <tr> <td>10.5</td> <td>Annual Compliance Assessment and Reporting</td> <td>Task</td> <td>10</td> <td>2027-04-15</td> <td>2027-04-28</td> </tr> <tr> <td>10.6</td> <td>Continuous Improvement Program Established</td> <td>Milestone</td> <td>0</td> <td>2027-04-28</td> <td>2027-04-28</td> </tr> </tbody> </table></div><div class="bottom-row"><div class="pull-right"><a href="planner/csv/1891" data-placement="bottom" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div></div> <h2 id="comprehensiveprojectnotes">Comprehensive Project Notes</h2> <h3 id="regulatorycomplianceframeworknotes"><strong>Regulatory Compliance Framework Notes</strong></h3> <p><strong>FDA DSCSA Compliance</strong>: With full enforcement effective November 27, 2024, the enhanced track-and-trace requirements mandate interoperable systems, product identifier verification, and comprehensive investigation processes. Implementation focuses on authorized trading partner verification, enhanced product identifier management, and real-time data exchange capabilities.</p> <p><strong>EU FMD Integration</strong>: The mature Falsified Medicines Directive framework requires seamless integration with European Hub systems, national repository connections, and anti-tampering device validation. Implementation emphasizes master data management, serialized pack data handling, and exception management across all EU member states.</p> <p><strong>India and China Requirements</strong>: Emerging serialization mandates in these markets require adaptive compliance frameworks supporting local regulatory requirements while maintaining global platform coherence. Implementation addresses unique data format requirements, local authority integration, and market-specific reporting obligations.</p> <h3 id="itsystemarchitecturenotes"><strong>IT System Architecture Notes</strong></h3> <p><strong>Multi-Jurisdictional Data Model</strong>: The platform architecture supports diverse regulatory requirements through flexible data models accommodating FDA DSCSA identifiers, EU FMD safety features, and Asia-Pacific serialization formats. Integration emphasizes real-time data synchronization, cross-border authentication, and regulatory reporting automation.</p> <p><strong>Enterprise Integration Strategy</strong>: Comprehensive integration with ERP, WMS, SCM, and QMS systems ensures seamless operational workflow while maintaining data integrity and regulatory compliance. Implementation prioritizes data consistency, audit trail maintenance, and performance optimization across integrated systems.</p> <h3 id="computersystemvalidationnotes"><strong>Computer System Validation Notes</strong></h3> <p><strong>CSV Compliance Framework</strong>: Validation follows FDA 21 CFR Part 11, EU GMP Annex 11, and international standards ensuring system reliability, data integrity, and regulatory compliance. The comprehensive approach includes DQ, IQ, OQ, and PQ phases with detailed documentation and approval gates.</p> <p><strong>Risk-Based Validation Approach</strong>: Implementation emphasizes critical system functionality validation while optimizing resource allocation and timeline management. Validation scope addresses serialization accuracy, authentication reliability, and regulatory reporting integrity.</p> <h3 id="vendormanagementnotes"><strong>Vendor Management Notes</strong></h3> <p><strong>Strategic Partnership Framework</strong>: Vendor selection prioritizes regulatory compliance expertise, technology integration capabilities, and global operational support. Qualification processes address technical capabilities, quality systems, and regulatory compliance history.</p> <p><strong>Performance Management System</strong>: Comprehensive vendor oversight includes KPI monitoring, compliance auditing, and continuous improvement processes. Management framework ensures service level maintenance, risk mitigation, and strategic value delivery.</p> <h3 id="riskmanagementnotes"><strong>Risk Management Notes</strong></h3> <p><strong>Data Security Framework</strong>: Multi-layered security approach addresses cybersecurity threats, data privacy requirements, and cross-border data protection compliance. Implementation includes encryption, access controls, monitoring systems, and incident response procedures.</p> <p><strong>Supply Chain Resilience</strong>: Risk mitigation addresses potential supply disruptions, vendor performance issues, and regulatory compliance failures. Framework includes business continuity planning, disaster recovery procedures, and alternative sourcing strategies.</p> <h3 id="operationalexcellencenotes"><strong>Operational Excellence Notes</strong></h3> <p><strong>SOP Library Development</strong>: Comprehensive operational procedures address serialization processes, verification workflows, compliance monitoring, and exception handling. Documentation supports multi-jurisdictional compliance while maintaining operational efficiency.</p> <p><strong>Training and Change Management</strong>: Strategic approach ensures user competency, system adoption, and ongoing compliance maintenance. Program addresses technical training, regulatory awareness, and change management support throughout implementation and operation.</p> <p>Would you like to expand the plan with additional columns such as Predecessor, Importance, Complexity, External Budget, FTEs Needed, or Functions, Roles, and Skills for complete resource and priority planning?</p> <p>How else can I help refine your global serialization anti-counterfeit compliance platform plan?</p> <div class="clearfix"></div> <p><span class="badge resp-time" style="background: none; border: solid 1px #ccc; color: #333;text-shadow: none; font-weight: normal; font-size: 14px; line-height:1.1;"> <i class="fa fa-clock-o" style=""></i> 2:49 </span></p></div>