Requirements Written After Purchase
Equipment was bought, installed, and then someone wrote the URS to match what arrived. Qualification becomes a paperwork exercise defending a decision instead of verifying a design.
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Service · Commissioning, Qualification & Validation
Facilities proven fit for intended use.
New line, new facility, new utility system — before it makes product, it has to be proven: designed right, installed right, operating across its range, performing consistently. We run the CQV lifecycle end to end, from user requirements through requalification, so your qualification package reads like the facility actually runs.
WHY NOW
Qualification failures are born in design.
Most of the expensive rework we see traces back to decisions made before a single protocol was written.
V-ModelRequirements flow down, verification flows up: every requirement gets a test, every test traces to a requirement. Gaps in the V are gaps in your evidence.
URS / DQUser requirements written after the equipment was purchased are wishes, not requirements. Design qualification catches the mismatch before it becomes concrete.
Continued VerificationQualification is not a one-time event. Without requalification and change control, the qualified state quietly expires — usually discovered during an inspection.
WHERE IT BREAKS
The four CQV failures we see most.
Expensive, disruptive, and almost always preventable with earlier structure.
Protocols That Don't Match the Floor
IQ/OQ/PQ documents describe an idealized system. Operators run the real one. The gap between the two is where inspectors live.
Utilities Never Qualified
HVAC, compressed air, purified water, steam — the systems every process depends on — were commissioned and forgotten. No qualification, no ongoing verification.
Requalification Never Scheduled
The initial qualification was years ago. Since then: changes, repairs, drift. Nobody requalified, because nobody owned the schedule.
OUR METHOD
The V-model, executed properly.
We manage the full lifecycle — not just the protocol execution in the middle, but the requirements at the start and the continued verification at the end.
Validation Master Planning
The strategy document that scopes the program: systems, risk levels, deliverables, responsibilities, and acceptance criteria — agreed before work starts.
URS & Design Qualification
User requirements in testable language, design reviews against those requirements, and risk assessments that focus effort where failure hurts most.
IQ / OQ / PQ Execution
Protocol development, execution support, and discrepancy management — installation verified, operational ranges challenged, performance proven under real conditions.
Continued Verification
Requalification schedules, change-control impact assessment, and periodic review — so the qualified state survives staff turnover and time.
WHERE IT APPLIES
One method, five industries.
Cannabis is our home base — the method was built there first. The same evidence discipline serves each industry below, mapped to its own regulations.
Food & Beverage
Preventive controls, supplier verification, environmental monitoring, and traceability under 21 CFR Part 117 and FSMA.
Dietary Supplements
Component qualification, master manufacturing records, and laboratory controls under 21 CFR Part 111.
Cosmetics
Safety substantiation, GMP records, and adverse-event readiness under MoCRA.
Pet Food
Preventive controls for animal food, supplier programs, and sanitation under 21 CFR Part 507.
QUESTIONS
CQV, answered.
What is the difference between commissioning and qualification?
Commissioning proves the system is built and works; qualification proves it consistently does what the process needs, documented to GMP expectations. Commissioning is good engineering practice — qualification is the regulated evidence layer on top of it.
Can you take over a CQV program mid-project?
Yes. We assess what's complete, what's defensible, and what's missing — then fill the gaps without redoing work that already holds up. Rescuing stalled qualification programs is a common engagement.
Do you develop the protocols or just execute them?
Both. We write IQ/OQ/PQ protocols in your format or ours, support execution on the floor, manage discrepancies, and assemble the final qualification package.
How do you handle legacy equipment installed years ago?
Through retrospective qualification: we assess available documentation and history, run targeted testing to fill the evidence gaps, and document a justified qualified state — without pretending records exist that don't.
Do you work on-site?
Yes. CQV is floor work. Protocol execution, walkthroughs, and testing support happen on-site; planning, document development, and review can run remotely.
Don't let the first gap be found under pressure.
Start with a free call about your facility, utilities, or equipment — what's qualified, what isn't, and what comes next. We'll name your top 3 GMP risks and give you an honest fit assessment. No pressure, no pitch.