Life science organizations operate in an environment where quality, patient safety and data integrity are paramount. As projects grow in scale and complexity, ensuring that CQV activities align with GMP and GDP expectations becomes increasingly difficult. Delays, documentation gaps or misaligned workflows can compromise compliance and disrupt critical project timelines, creating risk for both operational readiness and regulatory approval.

At SGS, we integrate CQV directly into your construction schedule, creating a seamless path from commissioning and qualification through to a fully compliant validation phase. Our regulatory expertise, combined with digital, paperless CQV documentation, ensures complete GDP alignment and reinforces data integrity at every stage. With global delivery capabilities supported by local teams and laboratories, we provide consistent, long‑term support – helping you to achieve safe, compliant and efficient project execution worldwide.

Life science CQV expertise

Early engagement
Integration of CQV into construction schedule is key; compliance from the start through user requirement definition, regulatory mapping and risk-based CQV strategies that minimize late-stage changes and qualification gaps.
Construction & commissioning readiness
Support installation verification, pre-commissioning and documentation control to ensure systems are prepared for structured qualification and validation.
Qualification & validation execution (IQ, OQ, PQ)
Perform Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), including process and cleaning validation, critical system testing and deviation management.
Digital CQV & documentation control
Use digital tools to streamline protocol execution, data traceability and document life cycle management, enhancing data integrity and audit readiness.
Regulatory readiness & inspection support
Prepare comprehensive validation packages, final reports and inspection support to ensure facilities are fully audit-ready and compliant for market approval.
Validated state maintenance
Sustain long-term compliance through change control, continuous improvement and ongoing validation support.

Business impact that matters

Our integrated CQV framework delivers measurable benefits across the project life cycle:

Commercial benefits
- Faster regulatory approval timelines
- Predictable validation milestones
- Reduced compliance remediation costs
Quality and compliance benefits
- Strong GMP and GxP alignment
- Audit-ready documentation packages
- Reduced inspection risk
Operational benefits
- Reliable system performance
- Controlled change management
- Long-term validation sustainability

Why choose SGS?

We are the world’s leading testing, inspection and certification company, recognized as the global benchmark for quality and integrity. Combining proven CQV methodology with deep GMP and GxP expertise, we support life sciences organizations worldwide with digital traceability, independent assurance and consistent global standards delivered through strong local execution.