Validation document review in minutes — every finding located, a quality reviewer decides
Every validation document comes back marked up in minutes, each finding located.
See one case, screen by screen ↓A TMV report, a DV protocol or an executed OQ lands in the quality reviewer’s queue with a due date. Before any judgement on the method or the result, the reviewer has to walk every section against the controlled template, look up every cited SOP and standard to see which revision was in force when the testing ran, and trace each requirement to a test step and a recorded result — then write it all up as comments on the document.
That mechanical part is where the misses are: a procedure cited at a revision superseded two months before testing, a calibration due date left blank, a requirement in the product specification that no test covers, a correction on the data sheet with no initials. Two qualified reviewers rarely return the same list, and when a controlled document gets a new revision, nobody goes back to the open reviews that still cite the old one.
Estimated split for one TMV report of about 11 pages, by hand and with the panel. Hours of reviewer time.
Five specialist agents review, reconcile and mark up every document; a quality reviewer decides.
Sam Patel has finished the test method validation report for the tip-to-shaft bond pull-force test on the Corventa 7F delivery catheter. Here is its review, screen by screen, in the working solution.
Dana opens the solution to 5 documents waiting for review, 3 critical findings open and a median of 14 minutes per review. Below her queue, the library changes that touch open reviews: SOP-MET-0031 rev E is effective, and 4 open reviews still cite rev D.
“They are markup for you to judge — the panel never approves.”
She drops in TMV-0193_TipPullForce_TMV-Report_Rev01.docx — 11 pages. The solution has already recognised it: a test method validation report on template TPL-TMV-002 rev F, product Corventa 7F delivery catheter, Plant 3 — Leiden, test dates 18–20-Aug-2026 taken from the data sheets.
“You decide what goes back to the author.”
The template reviewer maps 14 sections and 41 required fields and finds a blank field and no ndc. The citation reviewer reads 7 references and 4 instruments, resolves each revision at the test date and finds SOP-QA-0112 rev C superseded on 15-Jun-2026. The traceability reviewer collects 8 requirements from PRS-CV7-001, TMS-0193 and SOP-QA-0112 and finds R-4.2.3 has no test.
The reconciler merges duplicates, re-reads every passage and drops 2 flags the document does not support — Quality is named in §4.0 after all, and TMS-0193 rev B is in the library as a test method. What is left is graded and located: 2 critical, 4 major, 5 minor, marked on the pages of the report.
“11 findings · 2 critical — ready for your review”
§2.0 cites SOP-QA-0112 Test method validation at rev C. Rev D became effective on 15-Jun-2026, two months before testing began, and a timeline shows it. The finding explains why it matters: rev D requires ndc to be reported and be ≥ 5 — the gap the old reference hides is F-04.
Under the finding sit both revisions of SOP-QA-0112 with the passages highlighted, the suggested edit — rev C struck, rev D inserted — and who raised it: all three reviewers, confidence 98. Dana accepts it; the finding is marked Accepted and will go to Sam with the redlined copy.
The matrix lists 8 requirements: 6 traced, 1 partly traced, 1 untraced. R-4.2.3 — pull force ≥ 15.0 N after 2 h hydration at 37 °C — is in the product requirements and in the test method’s own scope, but no test in the report addresses it; the water bath WB-0306 is listed in §5 and never used. Criterion 6.2, ndc ≥ 5, has no reported result — from the reported components, ndc ≈ 7.
“The method would be released for a condition it was never validated for.”
Five files come back: the redlined Word with 11 tracked changes and 11 comments, an annotated PDF, the findings table, the pass/fail checklist and the traceability matrix. Each is stamped as advisory, and the controlled original is unchanged.
“Advisory review markup — not an approval”
Dana returns TMV-0193 to Sam Patel with the redlined Word, checklist and matrix. The message is drafted for her: cite SOP-QA-0112 rev D, and give R-4.2.3 a test or a justified exclusion, then resubmit as rev 02. Returning is her decision, recorded in the audit trail under her name.
Every night the panel is run on a locked pack of 36 seeded documents with 412 seeded defects. The September run: critical recall 96.8 % against a 95 % target, false positives 7.4 % against a 10 % limit. In the last 30 days, 38 reviews were completed. A new panel version ships only if critical recall stays at 95 % or above.
The same report, seen by the four people around it — what review looked like before, and what it looks like now.
Five specialist agents review, reconcile and mark up every document; a quality reviewer decides.
Identifies the controlled template from the document type and revision, maps every section and required field, and raises anything missing, blank or out of order — including statistics and signature blocks.
Resolves every reference against the document library by ID and revision, checks standards editions, and looks up the calibration record of every instrument.
Builds the requirement → test → result matrix from the product requirements, the test method and the governing SOP, in both directions.
Merges the three reviewers into one finding set: combines duplicates, re-reads each passage, applies your grading rules and records which reviewers agreed.
Writes the redlined Word with tracked changes and comments, the annotated PDF, the findings table, the pass/fail checklist and the traceability matrix.
Accepts or dismisses each finding. The agents propose; a named person decides.
Reviewers can ask about any review, finding or library document — or tell it what to change. Answers cite the library.
Why is F-01 on TMV-0193 critical?
Because the report cites a procedure revision that did not govern the work. TMV-0193 cites SOP-QA-0112 rev C, but rev C was superseded by rev D on 15-Jun-2026, and testing ran 18–20-Aug-2026. Rev D requires ndc to be reported, and the report does not report it — that is F-04. Your grading rule makes “governing procedure not current on the test date” critical.
Which open reviews have an untraced requirement?
Three: TMV-0193, R-4.2.3 · pull force after 2 h hydration; DV-0421, UR-2.3.1 · activation force after 24 h at 5 °C; PQ-0266, URS-14 · recovery to ISO 7 within 15 min. All three are graded critical.
Grade outdated standard editions as critical
Done. “Outdated edition of an external standard” is now graded Critical (was Major), saved as panel rules v13 under your name in the audit trail. It applies to new reviews; open reviews keep their grades. The next nightly answer-key run will show whether it moves the false-positive rate.
How does the panel score against the answer key?
On the locked answer key — 36 seeded documents, 412 seeded defects — the September run scored critical recall 96.8 % (61 of 63), major recall 93.1 % and false positives 7.4 %. The two missed criticals were both statistics claims on scanned data sheets.
13 screens from the working solution, on its sample data. Pick one to see it large.
Who reviews, how findings are graded and who decides are settings your panel owner changes.
| Setting | Default | Choose from |
|---|---|---|
| Reviewers on the panel | Template, citation, traceability | Each on or off · statistics reviewer in preview |
| When only one reviewer raises a finding | Keep it, marked “one reviewer” | Keep it, marked “one reviewer” · Drop unless two agree |
| Governing procedure cited at a revision not current on the test date | Critical | Critical · Major · Minor |
| Requirement with no test that traces to it | Critical | Critical · Major · Minor |
| Outdated edition of an external standard | Major | Critical · Major · Minor |
| Correction without initials, date or reason | Major | Critical · Major · Minor |
| Who decides findings on TMV protocols and reports | Dana Okafor | Dana Okafor · Omar Haddad · Lena Ortiz |
| What comes back | All five files | Redlined Word · annotated PDF · findings table · checklist · matrix |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample documents and answer key · “target” = the design goal, measured in the live solution · “estimated” = our estimate. People, companies and products named on this page are fictional — characters and sample data in the working solution.
A panel of AI reviewers that reads a validation protocol or report — DV, TMV, IQ, OQ or PQ — and returns a markup: findings graded by severity, a redlined Word, an annotated PDF, a pass/fail checklist and a traceability matrix. It is advisory only; a named quality reviewer decides every finding.
No. The panel can never approve, sign or move a document to Approved, and that setting is locked. It writes on a copy, and every file it returns is stamped “Advisory review markup — not an approval”.
The citation reviewer resolves every reference against your document library by ID and revision and reads the test dates from the data sheets. A citation counts as current only if its revision was in force on the first test date. When a new revision becomes effective, open reviews that cite the old one are re-checked and the reviewer is told.
The traceability reviewer collects requirements from the product requirements, the test method and the governing SOP, matches each to a test step and a recorded result, and maps every test back to a requirement. It flags requirements with no test, tests with no requirement and criteria with no reported result.
It is scored every night on a locked answer key of 36 seeded documents with 412 seeded defects. In the working solution’s September run, critical recall was 96.8 % and false positives 7.4 %, against a target of 95 % and above and a limit of 10 %. A new panel version ships only if critical recall stays at 95 % or above.
The reviewer dismisses it with a reason — not supported by the document, covered by a deviation, already fixed in a later revision, or their own words. Dismissals are recorded under their name and count toward the false-positive measure.
Yes. Which reviewers sit on the panel, what happens when only one reviewer raises a finding, how each kind of finding is graded, who decides each document type and which files come back are all settings.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your templates, document library and a sample of past validation documents — and it goes live once every quality gate has passed. We will walk you through it on your own documents first.
Any batch-record question answered in seconds, cited to the exact page and step.
1-min filmValidation DocumentsValidation protocols and reports drafted in minutes, every value traced to its source page.
1-min filmAsk the PlantBatch analysis that took three months now takes hours, with the query behind every answer.
1-min filmWe’ll run the review panel on a sample of your own validation documents, against your templates and library.