Validation document review that marks up every protocol and report in minutes, each finding located and sourced
Every validation document marked up in minutes, each finding located.
See one case, screen by screen ↓Software that checks validation protocols and reports — TMV, DV, IQ, OQ, PQ — before a quality reviewer approves them. Validation Document Review sends each document to four AI reviewers that read it separately for GxP, data integrity, test design and writing, and returns located redlines, a findings table by severity, a pass/fail checklist and a traceability matrix for the quality reviewer to decide.
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A TMV, DV or IQ/OQ/PQ protocol or report has to be checked against a lot before it is approved: the controlled template, every procedure and standard at the revision in force on the first test date, every requirement traced to a test and a result, every acceptance criterion stated before execution, every correction initialed, dated and explained, every instrument in calibration. A qualified quality reviewer does that by hand, page by page, against the document library.
Two reviewers rarely return the same findings, and what slips through is mechanical: a procedure cited at a superseded revision, a statistic the SOP requires with no criterion, an unexplained correction on a data sheet, a requirement no test covers. Find a missing criterion after a protocol is executed and the study is repeated. Find it at inspection and it can become an inspection observation.
Estimated split of about 3.5 hours for one TMV or DV document reviewed by hand, and the reviewer's time with the panel's markup in hand.
Four reviewers read each document on their own, agreement is marked, accuracy is scored; a quality reviewer decides.
Sam Patel needs TMV-0195 — the test method validation protocol for the marker-band vision system VM-05 on the Corventa 7F delivery catheter, Plant 3 — Leiden — approved before the study runs. Here is what happens to it, screen by screen, in the working solution.
Dana's review panel is open on TMV-0193, Sam's 11-page TMV report for the tip-to-shaft bond pull force. Four columns hold the GxP, data integrity, test design and writing reviewers' redlines, each with page, section and a strike-and-insert edit. Above them: 96.8 % critical recall and 7.4 % false alarms against 36 past human reviews. Seven of the 11 findings were raised by two or more reviewers on their own.
“Advisory panel. Four reviewers read independently; Dana Okafor decides every finding.”
Sam's protocol arrives as TMV-0195_MarkerBand_VM-05_TMV-Protocol_Rev00.docx. Before the panel runs, the document is read: a test method validation protocol, template TPL-TMV-001 rev D — flagged “rev E is current” — product Corventa 7F delivery catheter against requirement R-4.6, instruments vision system VM-05 and gauge block GB-11, site Plant 3 — Leiden.
“The panel returns redlines in four columns and marks where reviewers agree. You decide what goes back to the author.”
The GxP reviewer checks references against the library, the data integrity reviewer reads data sheets and records, the test design reviewer matches requirements to criteria, the writing reviewer reads for terms and numbering. Redlines land as they are found: the protocol is on a superseded template, the gauge block's calibration due date is blank, the ten parts were taken at random from lot 26-0412, “MSA” is used but not defined.
Below the columns, the reconciled findings fill in, with a dot under each reviewer that raised one.
The test design reviewer: “Nothing in Table 2 shows VM-05 can tell parts apart — no ndc ≥ 5 criterion”. The GxP reviewer: “Table 2 omits ndc ≥ 5, required by SOP-QA-0112 rev D §6.2”. The panel marks the agreement. Eleven redlines reconcile into 7 findings: 2 critical, 2 major, 3 minor.
“Two reviewers, working separately, flagged the same missing acceptance criterion.”
In the markup, F-01 sits on page 4, §6.0 Table 2. Table 2 states total GRR ≤ 20 % of the tolerance and operator bias ≤ 5 %, and nothing for ndc. The evidence opens SOP-QA-0112 rev D, effective 15-Jun-2026, page 6 §6.2 — ndc “shall be ≥ 5 and shall be reported” — and TPL-TMV-001 rev E, which asks for each criterion in the table before execution.
“With a ±0.3 mm tolerance, ndc is the statistic most likely to fail, so it has to be fixed in the protocol before anyone measures.”
Dana accepts the finding and it goes into the redlined copy for Sam. F-02 opens: the protocol was prepared on TPL-TMV-001 rev D, superseded on 01-Jul-2026 by rev E, which added the acceptance-criteria table — which is why F-01 exists. The suggested edit, rev D to rev E, and which reviewers raised it are on the same screen.
“F-01 accepted — it will go to Sam Patel with the redlined copy.”
The other findings are fixes Sam can make before execution: choose parts to span 9.7–10.3 mm from at least three lots, name the VM-05 export as the original record instead of copying readings by hand, measure from the distal tip as R-4.6 does, add GB-11's calibration due date. Dana returns the protocol with the redlined Word, the checklist and the traceability matrix, and a message: critical items first.
“Returning is your decision, recorded in the audit trail under your name. The panel's markup stays advisory.”
Back on TMV-0193, the traceability matrix maps 8 requirements from the product requirements, the test method and SOP-QA-0112 rev D: 6 traced to a test and a result, 1 partly traced, 1 untraced. R-4.2.3 — pull force ≥ 15.0 N after 2 h hydration at 37 °C — has no test. Q-6.2, ndc ≥ 5 and reported, has a criterion but no result.
The test design reviewer reads the matrix both ways: every requirement to a test, every test back to a requirement.
The accuracy scorer re-runs the panel on 36 past reviews your quality reviewers signed off — 412 findings raised by hand. GxP reviewer 97.1 % recall, data integrity 95.4 %, test design 96.0 %, writing 92.3 %. The panel missed 2 of 63 criticals, and both are named with what changed. The panel's critical recall has risen from 91.2 % in April to 96.8 % in September.
A new panel version ships only if critical recall stays at 95 % or better and false alarms under 10 %.
The library holds 4,812 controlled documents and 11,406 revisions, each with its effective date. When SOP-MET-0031 rev E became effective, the revision watch had the GxP reviewer re-check the 4 open reviews still citing rev D — DV-0418, TMV-0190, DV-0421 and OQ-0281.
The GxP reviewer judges a revision by the first test date, never by today's date.
The same protocol, seen by the five people who write it, review it, own the rules and keep the library — what their week looked like, and what it looks like now.
Four reviewers read each document on their own, agreement is marked, accuracy is scored; a quality reviewer decides.
Reads the document as a quality auditor would: the controlled template and its required sections and fields, every cited procedure and standard, and whether each revision or edition was in force on the first test date.
Checks raw data and records against ALCOA+: corrections with initials, date and reason, dates written DD-MMM-YYYY, original records named, instrument IDs matching their calibration records and in calibration on the test dates.
Builds the requirement → test → result matrix both ways and checks acceptance criteria stated before execution, part selection, sample sizes and statistics — recomputing GRR, ndc and capability from the raw data.
Reads for what makes a document ambiguous: abbreviations used before they are defined, IDs and revisions written two ways, tables and sections out of sequence, missing units and broken cross-references — with the exact replacement text.
Groups redlines that point at the same defect into one finding, marks which reviewers raised it, re-reads the cited passage, drops what the document does not support and says why, and grades each finding by your rules.
Writes the package: redlined Word with tracked changes and a comment per finding, annotated PDF, findings table, pass/fail checklist and traceability matrix.
Every night runs the panel on 36 past reviews and scores each reviewer against the 412 findings your quality reviewers raised by hand: recall by severity and the false-alarm rate.
Accepts or dismisses each finding. The agents propose; a named person decides.
Ask about a review, a finding, a reviewer's accuracy or a library document — or say what to change. Answers point to their sources.
Where did the reviewers agree on TMV-0193?
7 of 11 findings were raised by two or more reviewers working separately: F-01, SOP-QA-0112 cited at rev C (GxP, test design, writing); F-02, R-4.2.3 not traced to a test (test design, GxP); F-03, LC-2207 calibration due date blank (data integrity, GxP); F-04, ndc required but not reported (test design, data integrity); plus F-06, F-09 and F-10. Both criticals had at least two reviewers behind them.
Why is F-01 on TMV-0193 critical?
The report cites SOP-QA-0112 rev C, which was superseded by rev D on 15-Jun-2026; 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 a governing procedure not current on the test date critical.
How accurate is each reviewer against past human reviews?
Against 36 past reviews and 412 findings, in September: GxP 97.1 % recall, 6.2 % false alarms; data integrity 95.4 %, 8.8 %; test design 96.0 %, 7.9 %; writing 92.3 %, 9.6 %. The reconciled panel: 96.8 % critical recall, 7.4 % false alarms. It missed 2 of 63 critical findings.
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. Tonight's accuracy run will show whether the change moves the false-alarm rate.
13 screens from the working solution, on its sample data. Pick one to see it large.
Who sits on the panel, how findings are graded and who decides are settings, and every change is on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| When only one reviewer raises a finding | Keep it, marked “one reviewer” | Keep it, marked “one reviewer” · Drop unless two agree · Keep it, and ask a second reviewer to re-read |
| Governing procedure cited at a revision not current on the test date | Critical — blocks the document until fixed or justified | Critical · Major · Minor |
| Requirement with no test that traces to it | Critical | Critical · Major · Minor |
| Conclusion not supported by the reported results | Critical | Critical · Major · Minor |
| Outdated edition of an external standard | Major — must be fixed before approval | Critical · Major · Minor |
| Correction without initials, date or reason | Major | Critical · Major · Minor |
| Who decides findings, by document type | TMV: Dana Okafor · DV: Omar Haddad · IQ/OQ/PQ: Lena Ortiz | Dana Okafor · Omar Haddad · Lena Ortiz |
| Risk file reviewer | Off — preview, not yet scored | On · Off |
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 · “target” = the design goal, measured in the live solution · “estimated” = our estimate · ndc ≥ 5 is the AIAG Measurement Systems Analysis expectation, named as context. People, products, sites and documents named on this page are fictional — characters and sample data in the working solution.
Software that checks validation protocols and reports — TMV, DV, IQ, OQ, PQ — before a quality reviewer approves them. Validation Document Review sends each document to four AI reviewers that read it separately for GxP, data integrity, test design and writing, and returns located redlines, a findings table by severity, a pass/fail checklist and a traceability matrix for the quality reviewer to decide.
Each reviews from its own angle, and where two or more raise the same defect on their own, the panel marks the agreement. On the sample TMV report, 7 of 11 findings were raised by two or more reviewers. Findings raised by one reviewer are kept and marked, so you see exactly where the panel was alone.
Every night each reviewer is scored against an answer key of your own past reviews — in the working solution, 36 documents and 412 findings your quality reviewers signed off. Recall and false alarms sit at the top of each reviewer's column, and the Accuracy screen names every critical the panel missed.
Yes. The GxP reviewer resolves every procedure, template and standard against your document library by ID and revision, and judges currency by the first test date, not today. When a new revision becomes effective, open reviews citing the old one are re-checked.
No. The panel is advisory, locked that way in settings: it never approves, signs or moves a document to Approved. The markup writer works on a copy, never the controlled original, and the data integrity reviewer quotes raw data and never alters it.
Yes. A named quality reviewer for each document type accepts, edits or dismisses every finding and decides what goes back to the author. A dismissal needs a reason, and every decision is on the audit trail under the reviewer's name.
A redlined Word with tracked changes and a comment per finding, an annotated PDF, a findings table in Excel by severity with evidence, a pass/fail checklist against the template and a requirements-to-tests-to-results traceability matrix — each marked as advisory markup.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your templates, SOPs, document library and a set of past reviews to score against — 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 page and step.
1-min demoValidation Document AutomationProtocols drafted in minutes, every value traced to its source.
1-min demoManufacturing Batch AnalyticsBatch analysis that took three months now takes hours, with the query behind every answer.
1-min demoWe'll run Validation Document Review on a sample of your own past protocols and reports, and score it against your reviewers' findings.