Validation Services
Modern, Risk-Based Validation for Life Sciences Companies
Accelerating Compliance Without Sacrificing Quality
In regulated environments, validating your systems, equipment, and facilities is essential to ensure product quality, data integrity, and patient safety. But traditional Computer System Validation (CSV) methods are often slow, burdensome, and outdated.
At Sagax, we help companies adopt a modern, risk-based validation approach grounded in Computer System Assurance (CSA) principles—accelerating timelines while maintaining full compliance. From computerized systems to manufacturing equipment and facility qualification, we offer full-spectrum validation services aligned with GAMP 5, FDA guidance, and global regulatory expectations.
Focus on your business—we'll handle the rest with end-to-end management and seamless support!
Who We Help
- Startups and scaling companies transitioning from paper-based to digital systems
- QA/IT leaders modernizing from CSV to CSA
- Clinical and commercial manufacturers preparing for inspection
- Lab and facilities teams validating equipment and infrastructure
- Operations teams planning tech transfers, new facilities, or process scale-up
Get the right talent when you need it—our experts seamlessly extend your team for short- or long-term success!
Our Validation Service Areas
Validation as a Service (VaaS)
Ensuring Perpetual Validation for Your Entire Tech Stack
For SaaS, COTS, and rapidly evolving systems, one-time validation just isn’t enough. With frequent releases, vendor updates, and internal changes, companies need a way to stay continuously inspection-ready—without re-validating from scratch every quarter.
That’s where our Validation as a Service (VaaS) model comes in.
We offer a structured, scalable service that keeps your systems validated and your documentation up to date. This allows your internal teams to focus on science, operations, and delivery—while we manage the compliance overhead.
Focus on your business—we'll handle the rest with end-to-end management and seamless support!
What’s Included in VaaS:
Release Management
We review vendor release notes, perform risk assessments, and update test scripts as needed—validating only what matters.
Change Management
We document and evaluate internal system changes (configuration, roles, integrations) and maintain your validation traceability matrix.
Compliance Contracts
We establish periodic validation deliverables (e.g., quarterly reviews, validation summary reports) tied to your compliance and audit needs.
Vendor Oversight
We track your software vendors’ compliance posture, documentation practices, and updates to ensure alignment with your regulated use.
Streamlining GxP Compliance
We eliminate rework and reduce validation burden by applying CSA principles, reusable templates, and a risk-based validation approach.
Our VaaS clients often say this service is like having a full-time validation team on-call—without needing to actually hire one.
Who Is It For?
Teams using GxP-relevant SaaS systems (e.g., Veeva, Qualio, TrackWise)
Companies with multiple validated systems across functions
Clients undergoing frequent updates or releases
Those preparing for recurring audits or re-inspections
Businesses scaling quickly that can’t slow down for re-validation
Why Choose Sagax Team for Validation?
CSA Expertise with a Practical Lens
We don’t just follow the book—we bring critical thinking, risk assessment, and lean documentation to speed up validation without compromising quality.
GxP Experience Across IT, Labs, and Operations
From SaaS systems to chromatography equipment and clean utilities, our team understands the full scope of validation.
Flexible Delivery Models
We offer project-based, fractional, or fully managed validation support—depending on your internal capacity and needs.
Audit-Ready Documentation
We produce clear, regulator-facing documentation that holds up during inspections and reviews.
Tip: Did You Know?
The FDA’s CSA guidance encourages reduction in excessive testing and documentation. We help you take advantage of that—cutting time and cost while improving compliance.
What Our Clients Say
Our clients trust us to deliver effective, compliant, and results-driven solutions for the life sciences industry. See what they have to say about working with Sagax.
