Service 03 · CQV, engineering & PM
Commissioning, qualification, validation, and project support
Practical CQV and project execution for new suites, expansions, and process changes — sized for small and mid-size teams that need rigor without large-program overhead.
What this covers
C&Q and validation planning
Strategy and plans using a risk-based approach, aligned with your quality system.
Protocols & execution
IQ/OQ/PQ protocol development, field execution, and deviation handling.
Turnover & documentation review
Vendor turnover packages, FAT/SAT support, and traceability from requirements to testing.
Project management
Schedules, vendor coordination, and readiness tracking through turnover.
Engineering support
Facility, utility, and equipment engineering support for capital and renovation projects. Stamped engineering design is not offered.
Facility readiness reviews
A structured look at facility, utilities, and documentation against intended GMP use, with a prioritized action list. Useful for university spinouts and clinical-stage teams preparing a first GMP suite.
When teams call us
- You're building or fitting out a first GMP suite
- An expansion or renovation is underway
- New equipment or utilities need commissioning and qualification
- A process change calls for requalification
- Your team is stretched thin ahead of a milestone
What you receive
- C&Q / validation plan
- Protocols in your templates (or ours, for QA approval)
- Executed protocols and summary reports
- Deviation log and resolution records
- Traceability matrix
- Readiness tracker and punch list
How an engagement runs
- Scope
A short conversation about your facility, systems, timeline, and what your quality team needs to see.
- Plan
A written scope, method, and deliverables list, aligned with your SOPs and templates where they exist.
- Execute
On-site work with deviations raised as they happen — not after.
- Document & hand over
Reports and records formatted for your QA review and approval.
Standards we reference
References describe the methods we plan against; they don't imply endorsement or certification by any standards body.
Quantex Bioservices provides technical services and documentation support. Acceptance decisions remain with your quality unit. Information on this site is general and is not regulatory or legal advice.
FAQ
Do you replace our validation team?
We extend it. We can lead a scope or work under your validation lead's direction.
Can you use our templates?
Yes — that's the default.
Can you help a spinout or clinical-stage company that's never run a GMP facility?
Yes. A facility readiness review is a good starting point: it clarifies what's in place, what's missing, and what to do first.
Often paired with
Planning a new suite, an expansion, or a recurring test program?
Tell us what you're working on. We'll reply with a few questions, a suggested scope, and next steps.
Request a facility-readiness conversationOr email info@quantexbio.com