Validation Services
What Validation Really Means
Validation is the process of demonstrating—through documented evidence—that a system performs reliably, consistently, and as intended in real-world use.
It goes beyond testing features.
Validation confirms that:
Outputs can be trusted
Decisions based on the system are defensible
Risks are understood, controlled, and documented
In short, validation turns “we believe it works” into “we can prove it works.”
Why the FDA Requires Validation
The FDA expects organizations to demonstrate control over the systems that impact safety, quality, and effectiveness.
Validation ensures:
Systems produce accurate and repeatable results
Decisions are based on reliable data
Risks to patients and products are identified and mitigated
Digital tools do not introduce uncontrolled variability or failure
In regulated environments, validation is how trust is established—both internally and externally.
What We Deliver
Third Penguin provides right-sized, execution-focused validation aligned to real operations.
Core Deliverables:
Validation scope and risk assessment
Defined system controls and operating boundaries
Test cases with expected vs. actual results
Data input, output, and exception controls
User access, permissions, and workflow controls
Executive-ready validation summary and sign-off
Why Third Penguin
We focus on what matters most, without unnecessary overhead—helping organizations define the right controls and apply the right level of validation.
Our approach supports compliance, enables scale, and builds confidence across teams, leadership, and regulators—without slowing innovation.
Clear. Practical. Defensible.
Who Needs Validation?
Validation is essential for organizations that operate where patient safety, product quality, or regulatory oversight are involved, including:
Medical device and life sciences manufacturers
Healthcare and clinical technology companies
FDA-regulated organizations
Manufacturers using digital systems to support quality, production, or compliance
Teams deploying AI, analytics, or automation in regulated environments
If your system influences product quality, clinical outcomes, or compliance decisions, validation is expected—not optional.