Computer Systems Validation Services
Ensuring Compliance, Data Integrity, and Audit Readiness Across Your Regulated Systems
Experts in Computer Systems Validation of Laboratory Software
With over 30 years of CSV experience across pharmaceutical and life sciences organizations, Astrix brings a risk-based, regulation-aligned approach to every validation engagement. We design CSV processes grounded in the latest FDA guidance, GAMP® 5 best practices, and the specific characteristics of each system being validated — because no two systems, and no two organizations, are alike.
Our CSV services support new system implementations, system upgrades, legacy system remediation, and ongoing periodic review programs. We embed compliance into every phase of the validation lifecycle — from initial risk assessment through final system release.
What Is Computer Systems Validation — and Why It Matters
Computer systems validation (CSV) is a critical regulatory requirement for any life sciences organization operating under FDA or EMA oversight. As defined under FDA 21 CFR Part 11.10(a) and EMA Annex 11, Section 4, CSV provides documented evidence that a computer system consistently performs its intended function — delivering accurate, reliable, and audit-ready results that meet predetermined specifications and quality attributes.
In an FDA-regulated environment, a “computer system” encompasses more than hardware and software. It includes any instruments or equipment linked to the system, the standard operating procedures (SOPs) governing its use, and the trained personnel who operate it. Validation is not a one-time event — it is an ongoing process that must be maintained throughout the Software Development Life Cycle (SDLC) as systems evolve, are upgraded, or are replaced.
Failure to maintain proper validation exposes your organization to compliance risk, data integrity concerns, regulatory action, and business liability. Done right, CSV provides the foundation for compliant, inspection-ready operations.
Our Astrix CSV Process Includes
Qualification
Network & Infrastructure
Evidence that the network and infrastructure supporting the validated system has been correctly installed and is functioning as intended.
Installation
Test scripts and results confirming the system has been correctly installed in the user environment.
Operational
Test scripts and results confirming the system performs its intended functions in the user environment.
Performance
Test scripts and results confirming the system performs as intended under real-world conditions, including trained users following SOPs under worst-case scenarios.
Specifications
User Requirement
Clear documentation of what the system must do, including operational and regulatory constraints.
Functional Requirement
Documentation of how the system will look and function to meet defined user requirements.
Assessment & Planning
System Inventory & Assessment
Identification of all systems requiring validation and determination of appropriate validation scope and risk classification.
Risk Assessment
Structured analysis of failure scenarios and their potential impact on product quality, data integrity, and patient safety.
Validation Plan
A comprehensive plan defining validation objectives, scope, roles, responsibilities, and the approach for maintaining ongoing validation status.
Validation Report
A comprehensive review of all validation activities and documentation measured against the Validation Plan.
System Release Documentation
Final documentation confirming that all validation activities are complete and the system is approved for its intended use.
Why Life Sciences Organizations
Choose Astrix for CSV
Computer systems validation is not a commodity service — it requires deep regulatory knowledge, technical precision, and a methodology that holds up under inspection. Astrix brings all three.
Our validation professionals combine scientific domain expertise with regulatory fluency across FDA 21 CFR Part 11, EMA Annex 11, GAMP® 5, and GxP frameworks. We work as an extension of your team — aligning validation activities with your quality systems, timelines, and business objectives — so you can move forward with confidence that your documentation is inspection-ready.
Our CSV practice delivers:
- Reduced compliance and audit risk
- Faster time to system deployment
- Sustainable validation programs built for ongoing maintenance
- Documentation that meets FDA, EMA, and global regulatory expectations
- Peace of mind from validation experts with 20+ years of regulated industry experience
Ready to strengthen your validation program?