Computer System Validation/Assurance Service
Accelerate Digital Transformation in Regulated Industries with InspireXT’s risk-based approach to CSV
In highly regulated industries such as pharmaceuticals, healthcare, and life sciences, compliance is not just a regulatory obligation—it is a critical enabler of trust, quality, and patient safety.
InspireXT’s Validation as a Service (VaaS) helps organisations ensure their computerised systems meet FDA, EMA, MHRA, and other global regulatory requirements, protecting product quality and patient safety while minimising compliance risk and operational disruption.
By combining deep regulatory expertise with a risk-based validation approach, we streamline validation efforts, reduce costs, and accelerate project timelines. Whether you are implementing new systems, upgrading existing platforms, or managing ongoing validation, InspireXT acts as a trusted partner—delivering compliance with efficiency, transparency, and confidence.
Why Computer Systems Validation Matters
In regulated environments, every computerised system supporting product development, manufacturing, testing, or distribution must operate reliably, consistently, and as intended.
CSV ensures that systems:
- Protect data integrity
- Safeguard product quality
- Support patient safety
- Comply with regulatory expectations
Without effective CSV, organisations face increased risks including:
- Regulatory non-compliance
- Data integrity failures
- Product recalls
- Inspection findings, penalties, or licence suspension
A structured, risk-based CSV strategy is therefore essential—not only for compliance, but for sustainable business operations.
InspireXT’s CSV Expertise
Purpose-Built Validation for Life Sciences Organisations
InspireXT delivers accelerated, risk-based Computer Systems Validation services designed specifically for regulated life sciences organisations.
Our Validation as a Service (VaaS) goes beyond checklist-driven compliance. We embed validation excellence across the entire system lifecycle—ensuring speed, accuracy, and audit readiness from day one.
What differentiates InspireXT
End-to-End Validation Ownership
We manage the complete CSV lifecycle—from validation planning and execution to documentation and inspection readiness—across system implementations, upgrades, and ongoing operations.
Deep Life Sciences Domain Expertise
Our specialists bring hands-on experience across regulated environments and apply globally recognised frameworks aligned with FDA, EMA, MHRA, and GxP expectations.
Risk-Based, Audit-Ready Execution
Our proven methodologies reduce validation effort while maintaining traceability, consistency, and inspection confidence.
Digitally Enabled Validation
Advanced digital validation tools streamline planning, execution, and documentation—reducing manual effort, improving data integrity, and enhancing visibility across the validation lifecycle.
Our Approach to CSV
At InspireXT, we recognise that no two validation programmes are the same. InspireXT’s CSV approach is therefore tailored, risk-based, and industry-specific, aligned to your compliance obligations and strategic objectives.
Our Validation Framework
In regulated environments, every computerised system supporting product development, manufacturing, testing, or distribution must operate reliably, consistently, and as intended.
01.
Strategy & Risk Assessment
We define a purpose-built validation strategy based on system criticality, regulatory impact, and business priorities.
02.
Qualification & Testing
Led by experienced CSV specialists, we execute:
- Infrastructure Qualification (IQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ) / User Acceptance Testing (UAT)
This ensure systems perform reliably and meet full GxP requirements.
03.
Continuous Validation (cVaaS)
Our continuous Validation as a Service (cVaaS) supports ongoing validation and SaaS upgrades through robust change control and deviation management—ensuring systems remain in a validated state throughout their lifecycle.
04.
Business Impact & Optimisation
This expert-led, digitally enabled approach minimises validation time, cost, and resource dependency—allowing teams to focus on innovation, research acceleration, and operational excellence.
Why choose InspireXT
Accelerated Validation Cycles
Achieve faster go-live through reduced validation timelines and efficient execution.
Audit-Ready Systems
Ensure consistent compliance with FDA, EMA, MHRA, and global regulatory standards.
Superior Documentation Quality
Reduce documentation effort while improving accuracy, consistency, and inspection readiness.
Risk-Based Cost Optimisation
Minimise revalidation effort and cost during system upgrades using a risk-based cVaaS approach.
Improved Operational Efficiency
Enhance productivity, reduce errors, and optimise system performance across teams.
Compliance & Traceability
Maintain complete traceability through structured execution, audit logs, and detailed reports.
Request for services
Ready to accelerate your life sciences digital transformation with risk-based CSV services?
Schedule a personalised demonstration to discover how InspireXT helps you meet regulatory requirements while optimising system performance, efficiency, and long-term compliance.