Quality Validation
Our FDA-compliant validation process includes IQ, OQ, and PQ protocols with analytical sampling, reporting, and more.
What's Included
Everything required to take your system from installed to FDA-compliant.
Validation Binder
A fully prepared and pre-approved validation binder delivered before testing begins, so nothing stalls on documentation.
Analytical Sampling
Water quality sampling and analysis to support your compliance documentation.
Release for Use Approval
Formal sign-off that your system is validated and cleared for regulated use, with all documentation in order.
Saving you time & money
Validation Bottleneck, Eliminated
We solved a critical validation bottleneck that commonly stalls lab timelines, reducing what used to take up to a year down to just 15 minutes.
without PLS
1
year
with PLS
15
minutes
Our Process
Equipment & Scope Alignment
We define your water quality specification and system details up front.
IOQ Orientation
A structured kickoff meeting to align on port names, service cycle, and testing parameters before IOQ begins.
IOQ Execution & Approval
We execute installation and operational qualification testing against pre-approved requirements, then review for final approval.
PQ Orientation & Testing
We align on testing cadence, execute performance qualification, and walk through final results before sign-off.
Release for Use
Formal approval that your system is validated and cleared for regulated use, with all documentation complete.