Introduction
In the complex journey of bringing a product to market, two fundamental questions must be answered: “Did we build the product right?” and “Did we build the right product?” These questions represent Design Verification and Design Validation, respectively.
Within a Product Lifecycle Management (PLM) framework, V&V are not mere checkboxes at the end of development. They are continuous, interconnected processes that bridge the gap between abstract ideas and physical reality. While Verification focuses on adherence to technical specifications, Validation focuses on satisfying the end-user’s needs in real-world conditions. Failing in either pillar can lead to a product that is technically perfect but commercially useless, or a brilliant concept that is unsafe or unreliable.
Understanding the Difference: Verification vs. Validation
To master V&V in PLM, it is essential to distinguish their unique roles:
1. Design Verification (“Did we build it right?”)
Verification is an internal process. It confirms that the design output (the CAD model, the software code, the prototype) matches the design input (the technical requirements and specifications).
- Focus: Technical accuracy and compliance.
- Typical Activities: Inspections, walkthroughs, thermal analysis, and unit testing.
- Example: If the specification says the device must weigh less than 500g, weighing the prototype is a verification activity.
2. Design Validation (“Did we build the right thing?”)
Validation is an external-facing process. It proves that the finalized product meets the needs of the stakeholders and the intended users in its actual operating environment.
- Focus: Effectiveness, usability, and customer satisfaction.
- Typical Activities: Beta testing, clinical trials, simulated field use, and focus groups.
- Example: Even if the device weighs 500g (Verified), if a surgeon finds it too heavy to use during a 4-hour procedure, it fails Validation.
The V&V Workflow within the PLM Lifecycle
An integrated PLM strategy maps V&V activities across the entire development timeline, typically following the V-Model logic:
| Phase | Activity Type | PLM Integration |
| Requirements Definition | Validation Planning | Defining how user needs will be tested at the end of the project. |
| System Specifications | Verification Planning | Defining technical tests for each engineering constraint. |
| Detailed Design | Verification | Running simulations (FEA/CFD) to verify the design against specs. |
| Prototyping | Verification | Physical testing of components against technical drawings. |
| Final Product | Validation | Testing the “As-Built” product with real users in real scenarios. |
The Consequences of Fragmented V&V
Without a centralized PLM system, V&V often suffers from:
- Requirement Creep: Changes in design that are never re-verified.
- Compliance Gaps: Missing evidence that a safety-critical requirement was validated, leading to regulatory rejection (FDA, EASA, etc.).
- Late-Stage Discovery: Finding a validation error (user dislike) after the tooling is finished, which is 100x more expensive to fix than during the design phase.
How Visure Solutions Synchronizes Verification and Validation
The Visure Requirements ALM Platform provides the “Single Source of Truth” necessary to orchestrate complex V&V cycles:
- Dynamic Traceability Matrix: Visure automatically links user needs (Validation) to technical specs (Verification) and then to test results. This ensures that every requirement has a corresponding V&V activity.
- Automated Audit Trails: For regulated industries, Visure generates a complete history of V&V. You can prove who tested what, when, and with which version of the design.
- Suspect Link Management: If a user need changes, Visure flags all downstream technical specs and verification tests as “Suspect.” This prevents the team from verifying against obsolete data.
- Integrated Test Management: Visure allows for the execution of both Verification (technical unit tests) and Validation (user acceptance tests) within the same environment, providing a holistic view of product readiness.
Conclusion
Design Verification and Design Validation are the two halves of a successful product story. While Verification provides the technical confidence that the engine will run, Validation provides the market confidence that the customer will buy.
By embedding V&V into the heart of the PLM lifecycle through a robust platform like Visure, organizations move beyond “checking for errors.” They transition to a Quality-by-Design model where every technical decision is traced back to a human need. In today’s competitive landscape, the companies that thrive are those that can prove they built it right, and more importantly, they built exactly what the world needed.
Check out the 14-day free trial at Visure and experience how AI-driven change control can help you manage changes faster, safer, and with full audit readiness.
