Proof your facility does what you claim
Every clean room, autoclave, bioreactor, water system, and line in your facility carries an unspoken claim: that it does what your batch record says it does. Commissioning, qualification, and validation are how that claim is proven, on paper an auditor will accept. Done as box-ticking, CQV generates binders nobody trusts and delays that nobody planned. Done as a science- and risk-based program under ASTM E2500, it verifies what actually matters to product quality and gets your facility making product on schedule.
CQV is a chain of traceability. What you specify on the way down has to be verified on the way back up. When that linkage is clean, qualification is fast and defensible. When it's broken, you find out during an inspection.
We run the full arc, or step in at whichever phase your project has reached, without making you re-do the work already done well.
FAT, SAT, and system walkdowns that catch installation and function problems before qualification ever begins.
IQ, OQ, and PQ protocols authored, executed, and closed, each traced to the requirement it exists to prove.
Process validation and PPQ that demonstrate the process makes conforming product, batch after batch.
Requalification schedules, periodic review, and continued process verification that keep the validated state validated.
From a single autoclave to an entire new facility, we qualify the systems regulators expect to see under control, on a risk basis that puts the effort where product quality actually lives.
New builds, expansions, and clean room classification, qualified from URS through PQ against ISO 14644 and GMP grade requirements.
Water for injection, clean steam, compressed gases, and HVAC, qualified for the critical quality attributes they feed into the process.
Bioreactors, fillers, lyophilizers, autoclaves, and skids, qualified across their operating ranges and integrated into the process.
CSV under GAMP 5 and 21 CFR Part 11: automation, historians, and lab systems validated for data integrity, not just function.
Process performance qualification and continued process verification, from protocol design through the campaign that proves consistency.
Stalled, failed, or legacy qualifications assessed and brought current, so an old gap doesn't become the finding in your next inspection.
We don't publish vanity metrics. We run to standards, and we put them in writing at the start of every engagement.
Under ASTM E2500, verification concentrates on what affects product quality and patient safety. We don't qualify a light switch to the same depth as a sterilizer.
Every acceptance criterion traces to a requirement, and every requirement to a test. A reviewer can follow the thread from URS to executed protocol without a gap.
Protocols are authored so the person executing them can't reasonably misread a step. Deviations come from reality, not from ambiguous instructions.
We hand over a requalification and periodic review plan, so the validated state is maintained deliberately rather than rediscovered during an audit.
Our CQV leads have authored the protocols, run the executions, and closed the deviations on real start-ups under real schedule pressure. You aren't being staffed with junior consultants under a partner's name; you get the senior practitioner on every call.
Leads who have written IQ/OQ/PQ protocols and then executed them on the equipment, so the documents match how the systems actually behave.
The lead consultant on your engagement is the one doing the work. We don't bait-and-switch with junior staff after the contract is signed.
ASTM E2500 and ISPE Baseline fluency applied for real, focusing effort where quality risk lives instead of qualifying everything equally.
Practitioners who have carried facilities and systems to a validated state against fixed launch dates, and who plan CQV as a critical-path program.
Tell us what you're bringing online and when it has to make product. We'll match you with a senior CQV lead and respond within one business day. All inquiries are strictly confidential.