app.validleaf.com · Free self-serve tool
Data Integrity Gap Assessment
Answer 27 questions about how your site creates, reviews, and protects GxP data. The tool scores your answers, ranks every gap by risk, and produces a gap report mapped to the exact FDA guidance and regulations inspectors cite — the same findings that appear in recent FDA warning letters and Import Alert 66-40.
Who it is for
Small and mid-size U.S. manufacturers in regulated industries: cannabis, food & beverage, dietary supplements, cosmetics, pet food, and other regulated manufacturing — especially sites without a dedicated CSV / data integrity specialist.
What you get
A scored data integrity gap report: an overall score, a score for each of the 9 categories, and every gap ranked Critical, Major, or Minor with its regulatory mapping and a recommended remediation you can act on.
How it works
Deterministic scoring — no AI, no black box. Each question is weighted by risk; a Non-compliant answer on a high-risk control (shared logins, disabled audit trails) surfaces as a Critical gap. Takes about 15–20 minutes per system assessed.
Your answers stay in your browser. Nothing you enter here is sent to a server or to ValidLeaf. Your progress is saved on this device only, so you can close the page and resume later in the same browser. Print or save your report before you leave — clearing your browser data erases it.
1 · About this assessment
One assessment covers one system, piece of equipment, or process. Run a separate assessment for each system you want to evaluate.
2 · The 27 questions
For each control, choose the answer that matches how your site actually operates today — not how the SOP says it should. Add the evidence you would show an inspector (a procedure number, a screenshot, a log) in the notes field. Questions marked Warning-letter pattern reflect failure patterns cited in recent FDA warning letters and Import Alert 66-40.
3 · Your gap report
The report below updates live as you answer. When you are finished, print or save it — it is stored only in this browser.
Every report is a draft until an expert reviews it
This tool finds and ranks the gaps. It does not replace the judgment of a validation expert who knows your systems, your records, and your inspection history. Nothing on this page reaches ValidLeaf — but if you would like a human review, book a call and share the report you printed or saved. Team ValidLeaf reviews reports by hand for everyone who requests a review, and can work through the remediation with you, from audit-trail review procedures to a full data integrity remediation plan.
Get an expert review