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From Ticket Chaos to GMP Control: A Global Validated Systems Case Study

Many pharmaceutical companies view the go-live of validated global systems such as LIMS, EM, QMS, ERP, and MES as the final milestone. However, these systems continue to evolve after implementation.

After deployment, sites often submit enhancement requests through ticketing tools. Without structured demand management, requests become difficult to align, prioritize, and release in a controlled way.

This creates duplicated efforts, site frustration, internal conflicts, and risks to the validated state of computerized systems.

In this case, our team helped define a structured demand and release management approach to improve governance, transparency, and lifecycle control for validated global systems.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • Tickets Replaced Demand Management: Ticketing tools became the main source for enhancement requests, but they lacked a structured process, portfolio view, and clear ownership.
  •  Sites Solved the Same Problems Separately: Different sites raised similar issues, created separate solutions, and repeated the same discussions because requests were not centrally managed.
  • Decisions Lacked Transparency: Without a formal decision process, sites often received unclear rejection reasons and limited visibility into prioritization decisions.
  • Change Control Risks Increased: Poor demand governance reduced visibility of changes, weakened traceability, and created risks for validated systems.

Zamann Pharma Support’s Approach

  • Create Dedicated Demand Management: A demand manager reviews requests, identifies duplicates, prepares decisions, and communicates outcomes to sites.
  • Establish Clear Governance: The approach defines roles, responsibilities, and decision ownership through a documented RACI structure.
  • Build Structured Demand Packages: Related requests are grouped into demand packages and assessed by business impact, regulatory impact, technical feasibility, and validation impact.
  • Introduce Controlled Releases: Release planning, release notes, and validation documentation create traceability from demand through implementation.
  • Align With Validation Strategy: Demand management is integrated with computerized system lifecycle processes and risk-based validation activities.

Results Achieved

  • Improved Investment Decisions:A transparent and clustered view of global demands helps leaders understand where resources and investments are needed most.
  • More Efficient Rollouts:When organizations harmonize and prioritize demands, new site implementations can benefit from previous solutions instead of rebuilding similar approaches repeatedly.
  • Stronger Compliance Position:A controlled and documented lifecycle for global systems supports inspection readiness, reduces CAPA risks, and protects business operations.
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FAQ

1. Why are ticket-based enhancement systems risky for GMP validated computerized systems?

Ticket systems mainly support incident handling and individual requests. In GMP environments, validated systems require structured demand management, traceable decisions, risk assessment, and controlled releases to maintain the validated state.

2. How should pharmaceutical companies manage changes in global LIMS, QMS, MES, or other validated systems?

Companies should use a demand and release management model that includes a demand manager, governance structure, demand prioritization, impact assessment, release planning, and validation documentation.

3. What do regulators expect for changes to GMP computerized systems?

Regulators expect organizations to maintain the validated state, control and justify changes, document decisions, and protect data integrity and patient safety throughout the system lifecycle.