Pharma & biologics · FDA inspection readiness

Don't hand an inspector an easy finding.

Under deadline, the avoidable stuff slips through a GMP document — a date that doesn't line up, a root cause that just restates the symptom, a version identifier that isn't there. Dry Run reads your quality and regulatory documents and flags exactly that, before an FDA inspector does.

Industry built and tested · Free to try

The demo runs on sample data — no login, and nothing is sent anywhere.

One-page PDF The product sheet What Dry Run checks, and why quality teams trust the output. Download →
Built for GMP quality documents SOPs Deviations CAPAs Batch records Validation protocols OOS & quality events Screened against criteria referencing 21 CFR Part 211 · EU GMP — human-authored, never model-generated.

The findings that shouldn't happen

The hard part is judgment. The findings are often mechanical.

Inspection-readiness consultancies review these documents by hand, at volume, under the clock. The real work is judgment — but a lot of what actually gets written up is the avoidable kind: an inconsistency, a missing signature block, a “corrective action” that fixes nothing. Catchable. It just needs a second read that never gets tired.

“Root cause: operator error.”

Circular root cause

A cause that restates the symptom, and a fix that doesn't address why it happened.

Approved 28-Feb · investigated 03-Mar

Dates that don't line up

A sign-off dated before the work it attests to — the kind of thing an inspector circles first.

“…proceed as appropriate.”

Vague instructions

No defined criteria, no version identifier, no acceptance threshold. Easy to miss, easy to flag.

The first tool

Meet Dry Run.

Give it a document — an SOP, a deviation report, a CAPA, a batch record — and it screens the text against a fixed set of inspection-readiness criteria, returning one finding per criterion: what it looked for, what it found, and the exact line it's talking about.

Add a document

Paste it, or drop in a file — it's read right in your browser, never uploaded.

It screens every criterion

Dates, version control, cross-references, abbreviations, root-cause logic — one pass, each check independent of the others.

You get a work list

Per-criterion findings with the evidence highlighted and the reason spelled out — flags to fix, and the ones that need your call.

Fits where you already work

Take the findings with you.

Dry Run sits upstream of your quality management system — it catches the mechanical problems while a document is still being written, before it goes in for approval. When you're done, export the findings as CSV or JSON and load them into your QMS importer, hand them to a reviewer, or just work the list in Excel.

Export findings to Veeva Vault MasterControl Greenlight Guru Qualio TrackWise Excel Exports are plain CSV and JSON — nothing to install, no system to connect, no access to your quality system required. Product names are trademarks of their respective owners; Dry Run is not affiliated with or endorsed by them.

Where it stops

It triages. It never clears.

There's no overall score, no green checkmark, no “ready to submit.” Dry Run catches the avoidable so your scarce attention goes to the judgment calls — it doesn't make the call for you. For a reviewer who's professionally skeptical of software that overclaims, that's the point.

No overall verdictFindings are per-criterion. Never a single pass/fail or a compliance score.
No stored documentsStateless by design — your document never leaves the session.
No invented citationsEvery reference — 21 CFR Part 211, EU GMP — is human-authored and fixed, not generated on the fly.

Free training

The patterns, in under two minutes each.

Eight short animated explainers on the problems that show up in deviations, CAPAs, and quality records — circular root causes, ALCOA, what a checker can catch versus what needs a human, binder prep before a mock. No sign-up, no email, nothing gated. Watch one and you'll spot the pattern in your own records.

Built with a QC manager mid-BLA — for the people who do this by hand

See it on sample data, or screen your own.