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Commissioning, Qualification & Validation (CQV)

Structured CQV delivery that gets your facility to operational readiness — on schedule and inspection-ready.

Overview

From installation to validated operation

In GMP-regulated manufacturing, commissioning and qualification aren’t checkboxes at the end of a project — they’re the point at which everything upstream is proven to work as designed. Getting this phase right determines whether a facility is ready to manufacture, and whether it will stay ready.

Rockstone Engineering supports pharmaceutical and biotech clients through the full CQV lifecycle — from commissioning strategy and IQ/OQ/PQ execution through to final validation reporting. We work closely with project, quality and operations teams to ensure that validation activities are planned early, executed rigorously, and documented to a standard that satisfies both internal QA and regulatory inspection.

Whether supporting a new facility build, an equipment installation, a control system upgrade, or a process transfer, our CQV approach is practical, risk-based, and built around the realities of live project delivery.

If your CQV need relates specifically to a tech transfer or new product introduction — where the receiving site’s DCS and MES need to be assessed and aligned, not just qualified — see our Tech Transfer & Automation Alignment page.

What’s Included

CQV activities are scoped to your facility, your systems, and your regulatory framework — we work to your site standards, not ours.

  • CQV Strategy & Master Validation Plan (MVP)
  • Commissioning Planning & Execution
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Protocols & Reports
  • Risk-Based Qualification Approach (ASTM E2500)
  • CSV & Computer System Validation (CSV)
  • Regulatory Inspection Readiness
  • Deviation & CAPA Management

Our Approach

  1. Plan early, not at the end

    CQV strategy is defined during the design phase — not after installation. We work with project teams to build validation requirements into the project schedule from the outset, reducing last-minute re-work and timeline risk.

  2. Execute with rigour

    IQ, OQ and PQ protocols are developed to site standards and executed systematically — with full traceability, deviation management and real-time documentation to support the final validation package.

  3. Document to inspection standard

    Every validation deliverable is written to withstand regulatory scrutiny. We prepare validation reports, summaries and supporting documentation that are clear, complete, and audit-ready.

  4. Support operational handover

    CQV doesn’t end at sign-off. We support the transition to routine operations — ensuring the validated state is maintained and that operations and quality teams are confident in the systems they’re running.

What’s Included

Rockstone has supported CQV programmes across pharmaceutical and biotech facilities in Europe — delivering IQ/OQ/PQ and CSV activities aligned to EU GMP Annex 11, GAMP 5, and site-specific validation requirements.

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