Commissioning, qualification, and validation (CQV) consulting
End-to-end qualification of facilities, utilities, and process equipment for pharmaceutical, OTC, CDMO, and personal care manufacturers. We plan the work around risk, write to your templates, and execute alongside your staff.
What CQV covers
Commissioning, qualification, and validation is the documented evidence that a facility, utility, or piece of equipment is installed correctly, operates as specified, and performs consistently in routine use. Done well, it follows the V-model: every user requirement is traced to the test that proves it.
We support the full lifecycle, from the validation master plan and user requirements specification through design qualification, factory and site acceptance testing, and IQ/OQ/PQ, then on to periodic review and re-qualification.
Equipment and systems we qualify
Compounding and liquid lines, filling and packaging lines, fluid bed dryers, blow-fill-seal, and both aseptic and non-aseptic processes. On the utility side: purified water systems and temperature-controlled storage.
Following the risk-based verification approach in ASTM E2500, we focus formal testing on the functions that affect product quality and leverage vendor documentation and commissioning data where it is sound, so effort goes where the risk is.
What we deliver
- Validation master plans (VMPs) and project plans
- User requirements specifications (URS) and traceability matrices
- Design qualification (DQ) and system impact assessments
- FAT and SAT protocols and witnessing
- IQ, OQ, and PQ protocols, execution, and summary reports
- Vendor protocol review before execution
- Deviation handling and re-qualification
Regulations and standards
- 21 CFR Part 210 and 211
- ISO 22716
- ASTM E2500
- ICH Q9
- GAMP 5 for automated equipment
Common questions
What is the difference between commissioning, qualification, and validation?
Commissioning verifies that a system is installed and working to engineering specifications. Qualification (IQ, OQ, PQ) is the documented GMP evidence that the system is fit for its intended use. Validation is the broader term, most often applied to processes, cleaning, methods, and computer systems, showing they consistently deliver the intended result.
Can vendor IQ/OQ documents be used instead of writing our own?
Often, yes. Vendor protocols can save significant time, but they should be reviewed and approved by your quality unit before execution, and supplemented where they do not cover your user requirements or site procedures. We routinely review vendor packages and write the gap protocols.
Do you execute protocols on site?
Yes. We work on site across San Diego County and Southern California and support remote clients nationwide with protocol authoring, review, and reporting.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.