RRegscribe
Reference · read-only · zero AI cost

Sample report

A real, unedited excerpt of what Regscribe's output actually looks like — captured from a genuine run of the live analysis pipeline, not mocked up for this page. The document analyzed was a synthetic test fixture, deliberately built with several known defects to verify the tool catches them (see how the readiness gate works for the full logic). The findings below are exactly what the AI passes produced, trimmed to the most illustrative subset rather than every finding.

21 CFR Parts 210/211 (US Drug cGMP)

In-Process Quality Check: Tablet Weight Verification During Compression

SOP-QA-041 · Version 3

✕ Not ready

38 / 100 readiness score

Regulatory findings (2 of 19, most illustrative)

21 CFR 211.192criticalgap

Any unexplained discrepancy or failure to meet specifications must be thoroughly investigated, including assessment of whether other batches may be affected.

Evidence found: Section 4.4/5 describe segregating and reconciling out-of-range tablets against batch yield, but there is no reference to an investigation SOP, no threshold for when an out-of-range trend triggers a formal investigation, and no requirement to assess impact on other batches.

21 CFR 211.100(a)-(b)criticalpartial

Written production/process-control procedures must be followed and documented at the time of performance; deviations must be recorded and justified.

Evidence found: SOP defines a weight-check procedure with a sampling interval and specification, but Section 4.3 is incomplete — the procedure step describing what happens after batch-record verification cuts off mid-sentence with no continuation.

Document integrity

Structure

Section numbering skips from "2. Scope" directly to "4. Procedure" — Section 3 is missing entirely. A procedure step (4.3) is also incomplete, cutting off mid-sentence with no continuation.

Signatures

Prepared by, Reviewed by, and Approved by are all present and visually confirmed signed. The "Quality Head Countersignature" block is listed as required but is visually blank — no name, date, or mark.

Dates

The "Reviewed by" signature date (2 June) is dated after the "Approved by" signature date (28 May) — flagged as an illogical ordering, since review should logically precede approval in a document's lifecycle. This check is deterministic (plain code, not an AI judgment) — see how it works.

Why this document is "Not ready"

Per the deterministic gate logic: two critical regulatory gaps, one blank required signature block, and missing document structure elements are each independently sufficient to block a document — this one has all three. See how the readiness gate works for the complete, exact rule set.

What a "Ready" result looks like

We're not showing a fabricated clean example here — every test document we've run so far was deliberately built to have known defects, since that's what proves the tool actually catches problems rather than rubber-stamping everything. Structurally, a "Ready" result is simple: no critical regulatory gaps, no blank required signatures, no missing structure elements, and a complete set of QMS metadata (owner, approver, effective date, periodic review) — the same rules shown above, just with nothing tripping them.

Full readiness checks also cover QMS metadata extraction and advisory proofreading, not shown above for brevity. Try it on your own document — sign-in required, invite-only.