VALIDATION-as-a-SERVICE (VaaS)

Validation Services That Prevent Costly Rework

Validated Cloud offers comprehensive validation services including computer system validation, process validation, and data validation. Our Validation Services team delivers the documentation and risk profiles each validation task requires, tailored to your company's stage and needs.

Pre-commercial companies often try to save money initially but don't understand the long-term implications when incomplete validation activities fall short just before FDA/EMA inspections. These efforts require expensive rework that costs far more than doing it right the first time. Don't let sole focus on FDA approval leave your company short for EMA compliance—covering both expectations initially is far more efficient than separate gap analyses and remediation plans.

SaaS Risk Management for the Real World

SaaS solutions promise cost savings and reduced operational burden, but most providers push changes without customer input or control. Multi-tenant platforms serving multiple customers create uncontrolled impacts across their customer base. You've given up control in exchange for price, while SaaS providers have taken some responsibility (for a fee) but left you with the hardest parts to manage.

While some SaaS solutions truly deliver value, too many providers have successfully caught the GxP SaaS wave without earning it. We help you separate the wheat from the chaff.

Modern Audit Services Beyond Compliance

Validated Cloud provides comprehensive audit services that go beyond traditional compliance. A decade ago, auditing focused primarily on compliance. Today, security has become an equal partner to GxP compliance in the auditing process—but we believe this still isn't complete for modern risk assessment.

The missing third component is the technology stack and how it's assembled. This platform layer is where catastrophic issues occur, yet it's a modern gap in most auditing processes. Software can have bugs and hotfixes, but a poorly designed technology stack, technical debt, or insufficient support resources can leave your company without critical services for uncontrollable periods.

The explosion of GxP SaaS has pulled in many vendors who aren't up to the task, while traditional auditors don't know how to ask the right questions to understand the complete risk profile.

Quality System Foundation for Growth

Phase 2 and some Phase 3 sponsors often have no quality system or only pieces of one. The Validated Cloud starter quality system gets you from nothing (or near nothing) to a quality system that can support deploying and maintaining your first validated computerized systems.

Our quality system includes all the basics, and our experienced quality team guides you through the processes while providing a quality skeleton to build from. We're designed to get you in position to have a quality system that supports validated systems and, when the time is right, to take our artifacts, customize them, and own them. Think of us as the support system that gets you ready to stand on your own.

Global Regulatory Strategy from Day One

The difference in auditing and scope between FDA and EMA has evolved significantly over the past decade. FDA has moved toward pushing universal risk management to sponsors, while EMA is training inspectors to look beyond efficacy and safety of new drugs, therapies, and devices.

Building controls for both FDA and EMA approval from the onset requires only a modest additional effort. The alternative—embracing one regulator's requirements after building a quality system for the other—can double your effort. Build your quality system with the lowest common denominator of FDA, EMA, MHRA, best practices, and subject matter expertise requirements. This approach saves significant time and money as your drug, therapy, or medical device pursues new regions for distribution.