Quality · 5 of 7 services
Test menu validation
Validation planned, executed and signed.
Protocol, execution, signature · Per analyte · Audit ready
What you receive.
Validation is where a good laboratory quietly accumulates risk. The studies get run, the data sits in a folder, and no one signs a summary. A surveyor asks for the package, not the intention, and the package is what this engagement produces.
- A validation protocol written before any sample is run
- Accuracy, precision, reportable range and reference interval studies
- Analytical sensitivity and specificity where the method requires it
- A data package with raw results, statistics and acceptance criteria
- A validation summary signed by the laboratory director
- The procedure and quality control plan that follow from the data
What the package covers
Every element a surveyor expects.
Accuracy
Comparison against a reference method or material.
Precision
Within-run and between-run, at decision levels.
Reportable range
Linearity across the claimed interval.
Reference interval
Verified or established for your population.
Carryover and interference
Where the method calls for it.
Director sign-off
Dated before patient testing begins.
The engagement
Protocol before samples, sign-off before patients.
Protocol
Week 1
Study execution
Weeks 2 to 4
Data package
Week 5
Sign-off and go-live
Week 6
Before you engage
Price: fixed fee per analyte or per platform.
Lead: a named partner, in your proposal.
How it starts: a 20-minute call, then a written scope and fee before any work begins.
Questions
Verification or validation?
An unmodified FDA-cleared test on its intended sample type is verified. A modified test, a laboratory-developed test, or an off-label sample type is validated. The difference decides the size of the study.
Can we use the manufacturer data?
For verification, in part. The regulation still requires you to demonstrate performance in your own hands.
Who runs the samples?
Your staff, on your instruments, with our protocol and oversight. That is what makes the record yours.
Cited on this page
- 42 CFR 493.1253, performance specifications (ecfr.gov)
- 42 CFR 493.1213, test method validation (ecfr.gov)
Citations link to the official text. Nothing here replaces the current checklist issued by your accrediting body, and we read that checklist with you rather than in place of you.
Validation that survives review.
Twenty minutes, then a written scope. Nothing starts until you sign it.