Quality & Compliance
Validation & Qualification (CQV)
Commissioning, qualification and validation that regulators accept the first time.
Overview
What this capability means at OneFit Projects
Our CQV teams deliver the full validation lifecycle for regulated manufacturing: from user requirements and design qualification through IQ, OQ, PQ and ongoing periodic review. We work under GAMP 5, ISPE baseline guides, ISO 13485 and FDA expectations, and we write documents inspectors can actually read.
How we engage
- Scoped studies with fixed deliverables and price
- Turnkey packages delivered with our engineering, quality and digital teams
- Embedded specialists working in your tools and processes
- Retained support under a framework agreement
Service lines
8 ways we deliver validation & qualification
Validation master planning
VMP, validation strategy, risk-based scoping and resource plans for greenfield and brownfield sites.
Equipment qualification
URS, DQ, FAT, SAT, IQ, OQ and PQ protocols and execution for process, packaging and utility equipment.
Computerised system validation
GAMP 5 lifecycle for PLC/SCADA, MES, LIMS, BMS/EMS and lab systems, including 21 CFR Part 11 and data integrity.
Cleanroom & HVAC qualification
Airflow visualisation, particle counts, recovery, pressure cascade and ISO 14644 classification.
Utility qualification
Purified water, WFI, clean steam, compressed air and nitrogen systems to pharmacopoeial requirements.
Process & cleaning validation
Process characterisation, PPQ, continued process verification and cleaning validation studies.
Test method & measurement validation
Gauge R&R, MSA, test method validation and calibration programme design.
Medical device V&V
Design verification and validation planning, test protocols, biocompatibility and usability studies under ISO 13485.
Tools, platforms and standards
What we work with
We work in the platforms our clients already use, and we document to the codes their regulators, auditors and customers expect.
- GAMP 5
- ISPE Baseline Guides
- ISO 13485
- 21 CFR 820
- 21 CFR Part 11
- EU Annex 11 & 15
- ISO 14644
- ASTM E2500
Where we apply it
Industries served by this capability
Pharmaceutical
GMP facilities, equipment and systems qualified for global regulatory inspection.
Industry pageMedical Devices
Design, validate and manufacture devices that regulators trust and clinicians rely on.
Industry pageFood & Beverage
Hygienic design, automation and traceability for safe, efficient food production.
Industry pageBiotech & Life Sciences
Lab to commercial scale, engineered for biological processes.
Industry pageElectronics & Semiconductor
Cleanroom facilities, precision automation and thermal engineering for electronics.
Industry pageChemicals & Process
Process, mechanical and safety engineering for plants that run hot, high and hazardous.
Industry pageRepresentative engagements
Validation & Qualification in practice
Automated verification system for a Class II infusion pump line
Designed, built and qualified an end-of-line flow-accuracy and occlusion test system with 21 CFR Part 11 compliant data capture.
Commissioning and qualification of a greenfield oral solid dosage facility
Delivered the full CQV programme for a USFDA-targeted OSD plant, including 60+ equipment items, HVAC, utilities and BMS.
CFD-led cleanroom airflow design and qualification for an aseptic filling suite
Used CFD to design unidirectional airflow and pressure cascades for a Grade A/B suite, then qualified the installed system.
Related capabilities
More from our quality & compliance practice
Need validation & qualification on your next project?
Share the scope, constraints and timeline. A senior engineer will respond with a practical path forward, whichever discipline it touches.