Computer System Validation

Computer system validation (CSV)

Quality assurance & computer validation solutions

We provide expert Quality Assurance & Computer System Validation (CSV) services to pharmaceutical, medical device, and biotechnology companies in the life sciences sector. Our tailored approach delivers compliant, auditable software and system testing that aligns with your organization’s needs and meets relevant industry standards and regulatory expectations.

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Expert support for audit-ready compliance

Tailored project plans

Develop customized project plans that align with your specific CSV needs, ensuring that all aspects of the validation process are covered comprehensively.

Experienced project leadership

Our team of seasoned project managers and analysts specialize in CSV, bringing a wealth of knowledge and experience to guide your projects to successful completion.

Regulatory alignment

We ensure that every project adheres to the latest FDA and other relevant regulatory guidelines, keeping your systems compliant and audit-ready.

Resource coordination

From coordinating cross-functional teams to managing vendors and technology partners, we handle all aspects of resource allocation and scheduling.

Risk mitigation

Our proactive approach to risk management identifies potential issues early, allowing for timely interventions to keep your project on track.

Communication & reporting

We maintain clear and consistent communication with all stakeholders, providing regular updates and detailed reports on project progress.

Delivered audit-ready validation across 40+ systems

Wavestone partnered with a global healthcare leader to validate more than 40 systems across four parallel workstreams during a large-scale IT transformation. Our team led planning, risk classification, testing, and documentation to support compliance with FDA and GxP standards. The result was a successful migration delivered on time, with complete audit readiness and validation at scale.

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Partner with Wavestone for reliable Quality Assurance and CSV services that deliver compliance and confidence in your computerized equipment and systems.