A Scalable, Risk-Based Approach to Global Validation

“Trissential is a great partner. We did not ask them to propose a CSA Competency Center. They saw a business opportunity that aligned with our challenges. When they proposed an overall solution that reduced our organizational risk, streamlined, and automated our processes, and cut overall organizational spend, it was a no brainer.” – Executive Technical Director of IT Compliance

A global leader in luxury consumer goods partnered with Trissential to reduce costs and accelerate time-to-market for new products. Known for excellence and innovation, the organization needed a smarter, more scalable approach to regulatory compliance and product validation.

Challenge

As a regulated enterprise, the organization was required to validate systems, equipment, and processes to meet strict FDA standards. However, the cost of validation was too high, decisions were driven by fear rather than risk, and the approach lacked consistency across the business. Roles were unclear, documentation was excessive, and teams were burdened by inefficiency and compliance fatigue.

Solution

Trissential introduced a Validation-as-a-Service (VaaS) model within a centralized CSA Competency Center, aligned with modern FDA guidance favoring risk-based, automated validation. Key elements of the solution included:

• Establishing a global Competency Center to standardize processes and technology
• Defining clear roles and responsibilities to eliminate ambiguity
• Implementing five pillars for sustainable transformation: Leadership, Services, Enablement, Organizational Change Leadership, and Global Harmonization
• Rolling out a CSA strategy and roadmap with governance, templates, and best practices
• Launching a value model to evaluate risk, scope, and ROI before project initiation
• Delivering training, coaching, and on-demand expertise to support adoption

Results

The organization is already seeing measurable results:

• Faster validation cycles and improved quality outcomes across global teams
• Reduced time-to-market by 35%
• Initial 20% cost reduction, with an additional 15% projected for following year
• Lower regulatory burden and reduced manufacturing risk