Risk-Based Commissioning
URS to VMP, RTM and DQ — prioritised testing focused on product quality and patient safety. Includes IQ / OQ / PQ protocol authoring, execution, deviations and audit-ready summaries.
Commissioning & Qualification
Join a team of specialists executing end-to-end commissioning, qualification, and validation projects that ensure reliability, compliance, and operational readiness.
End-to-end commissioning & qualification expertise
CSV & Data Integrity
PLC/SCADA, DCS, MES, historians — validation plans, RTM, security, audit trails, backup/restore and report packs aligned to Annex 11 and 21 CFR Part 11.
Utilities & Process Equipment
HVAC, WFI, Clean Steam, CIP/SIP, autoclaves, isolators, packaging and lab systems — commissioned and qualified with integrated change, deviation and punch-list control.
Process Validation & Start-up Support
PV strategy and PPQ readiness, CPV set-up and APR link-up. Site-based troubleshooting that unblocks issues fast and keeps startup dates on track.
Why leading pharma firms choose Rockline C&Q
We deliver fast, compliant, and results-driven Commissioning & Qualification — combining automation expertise, regulatory alignment, and real-world site experience to help you reach release safely and efficiently.
Speed without shortcuts
- Standardised templates and documentation frameworks.
- Risk-based testing ensures effort is focused where it matters most.
- Faster qualification while maintaining full audit readiness.
Automation + C&Q under one roof
- Integrated approach between automation design and qualification.
- DCS, PLC, MES, and historians validated as part of project delivery.
- Reduced handover friction and single accountability for performance.
Hands-on, senior leadership
- Site-based delivery led by David O’Mahony.
- Proven track record across complex European pharmaceutical startups.
- Guidance from seasoned C&Q professionals who know your process.
