Services
Commissioning, Qualification, & Validation (CQV)
Our experts in CQV help pharma and biotechnology clients meet their goals (and schedules)
In pharmaceutical manufacturing, time is revenue. When commissioning, qualification, and validation are left to the final stretch of a project, even small gaps can cascade into production delays, rework, and regulatory exposure.
At Salas O’Brien, CQV is integrated from day one.
We align engineering, construction, and quality teams early so protocols are built alongside design—not layered on after the fact. That means fewer surprises during startup, fewer change orders late in the schedule, and a smoother path to operational readiness.
Our teams understand both the technical systems and the compliance environment. We design facilities with qualification in mind, develop documentation that stands up to regulatory scrutiny, and execute testing that reflects real operating conditions, not theoretical performance.
Understanding CQV in pharma
What we can offer
Salas O’Brien provides CQV services that verify systems and processes are installed correctly, function as intended, and meet regulatory standards for pharma and biologics manufacturing.
Audit‑ready compliance backed by real‑world expertise
Salas O’Brien brings deep cGMP and GxP experience across facilities, laboratories, utilities, and manufacturing environments. Our team enables documentation and validation approaches that are operationally defensible—supporting inspections with confidence, not just compliance on paper.
End‑to‑end CQV leadership for complex projects
Salas O’Brien manages and coordinates CQV for greenfield and brownfield projects, aligning contractors, MEP field testing teams, OEMs, and cGMP segregation requirements. Early, integrated leadership minimizes handoffs, reduces risk, and keeps schedules intact.
Early integration that protects schedules
By embedding CQV from day one, Salas O’Brien informs design decisions rather than reacting after construction. This proactive approach eliminates late‑stage surprises and reduces costly rework across utilities, clean rooms, HVAC, BMS, and process systems.
System‑wide validation through multidisciplinary expertise
Salas O’Brien’s in‑house engineering teams validate critical systems across the facility lifecycle—utilities, clean rooms, chambers, automation, packaging, and process equipment—with unmatched consistency and technical depth.
Proven expertise across equipment and automation
Salas O’Brien validates complex process equipment (tanks, dryers, isolators, freezers), packaging lines (sorters, fillers, serialization, cartoners, case packers), and automation platforms (PLC, HMI, SCADA, BMS), providing seamless integration and compliant performance.
Documentation systems that sustain compliance
Salas O’Brien builds scalable documentation systems and trains teams to sustain long‑term compliance. Our approach strengthens data integrity, operator readiness, and audit resilience.
Risk‑based design for validated facilities
Cleaning validation excellence
Salas O’Brien combines process engineering, equipment knowledge, and CQV rigor to deliver efficient, compliant cleaning validation protocols tailored to real production conditions.
