CQV (Commissioning, Qualification & Validation) is a critical discipline in the life sciences industry that ensures manufacturing facilities, utilities, systems, and equipment operate according to defined requirements, regulations, and intended use.
At eLife Sciences, we provide end-to-end CQV services, helping clients bring production assets into qualified, compliant, and operationally efficient states—ready for audit, inspection, and commercial use.
What we offer
Commissioning
We verify that systems and equipment are installed and functioning according to design specifications.
Design Qualification (DQ)
We ensure that design outputs meet user requirements and regulatory expectations from the start.
Installation Qualification (IQ)
We confirm that equipment and systems are installed correctly with documented verification.
Operational Qualification (OQ)
We test operational performance under expected ranges and document consistent results.
Performance Qualification (PQ)
We verify that systems consistently perform as intended under routine, real-world conditions.
Validation Master Planning (VMP)
We develop comprehensive CQV strategies aligned with GMP, internal procedures, and lifecycle risk management.
Documentation & Regulatory Compliance
All documentation is audit-ready and aligned with EU GMP Annex 15, FDA guidance, and current best practices.
Our experienced engineers and validation specialists support projects across greenfield sites, facility upgrades, and equipment replacement initiatives. Whether you’re building new capacity or modernizing legacy assets—CQV with eLife Sciences means readiness from day one.
Do you need a consultation? Contact us.
We will be happy to review the details of your project and help you choose the most optimal solutions.