IT Automation Retirement Plan for Manufacturing Closure at Merck & Co., Las Piedras

Abstract

This project establishes a complete IT Automation Retirement Plan to support the manufacturing closure at Merck & Co., Las Piedras, by December 2025. It defines a regulatory-compliant framework for decommissioning IT systems, aligned with FDA/GMP, ISO, ITIL, and data protection standards. A structured methodology was applied to assess system inventory, validate data integrity, and securely archive records. During execution, systems were prioritized by criticality, validated, and decommissioned in phases to avoid disruptions. The project involved cross-functional teamwork, such as quality assurance, IT compliance, and manufacturing, to guarantee the project's alignment with the organization's goals and regulatory compliance. Lessons learned and documentation standards were harvested to advance knowledge transfer and reuse in future site closures or technology retirement activities. This framework scales verified operational models for regulated industries, reducing the risks associated with operations without compromising their compliance and integrity. Key Terms ⎯ Data Retention, Decommissioning, FDA Compliance, Risk. Mitigation