Local label compliance against the CCDS, meaning by meaning, in every language
Every local label read in its own language and checked against the core data sheet, meaning by meaning.
See one case, screen by screen ↓A core data sheet changes once; its local labels change in many languages, each in its own national template, each at its own time. The bula numbers its sections one way, the package insert another, the IPP puts contraception under pregnancy and lactation. A shortened sentence in a reformatted version, or a number that slipped in a translation round, sits in the label until somebody reads it against the CCDS line by line.
That reading is slow work. Someone translates the label back to English, finds where each CCDS meaning landed, decides whether the difference is a health-authority requirement, a template rule or a real error, checks whether a justification is already on file, and writes the register entry. Done by hand across a whole wave, the register is never quite current — and the critical deviation is found late.
Estimated hours of people time on one label’s first pass, by hand and with the agents, as the working solution’s dashboard shows them. The person still decides every deviation.
Specialist agents read, translate, align and classify every local label and draft each fix; a medical risk assessor decides every deviation.
The Mexico Información para prescribir (IPP) v4 for Veltrimab arrives at 07:20 from the affiliate. Here is what happens next, screen by screen, in the working solution.
Maya opens the audit for Veltrimab, CCDS 15.0: 24 local labels in 19 languages, with the inspection-ready register due Nov 20. Eight labels are signed, 13 deviations are waiting for her decision, and four critical deviations sit on the critical wall — Brazil, Argentina, Türkiye and China — each due at the Labeling Committee within 2 business days.
“China · §4.4 Live vaccines — Local text says at least 8 weeks · CCDS: at least 18 weeks.”
Diego Navarro, affiliate regulatory for Mexico, has sent the IPP v4: 14 pages in Español, as a DOCX. Maya opens it. The CCDS meanings sit on the left; the local sections, still unread, on the right, in the IPP’s own order.
“Five agents read it, write an English reading, align every meaning with CCDS 15.0, classify each deviation and check the register. You decide what they find.”
The Label Intake Reader finds 14 pages and 13 local sections. The Label Translator writes an English reading of 5,480 words, 64 % of it from the translation memory, with the glossary applied. The Meaning Aligner pairs all 12 CCDS meanings and finds one local addition; the Deviation Classifier finds three deviations, one of them critical.
Every step shows what it found, and the last one says who decides: “Ready for a person — Dr. Maya Chen decides.”
Threads join each CCDS meaning to the local sentence that carries it. They cross where the Mexican template reorders sections — §4.6 Contraception lands in “8. Embarazo y lactancia”, the dosing sections in “13. Dosis y vía de administración”. Same meaning in green; justified, unjustified and critical each in their own colour.
One switch shows the agent’s English reading, another shows only the deviations. The original Spanish stays the source of truth: the reading is for comparison, and the translator never corrects a number or a unit.
§4.6 Contraception, DEV-MX-08. The CCDS asks for effective contraception for at least 18 weeks after the last dose; the IPP says “al menos 8 semanas”. Rule R-02 — a changed number in a dose, interval or duration is critical — at 97 % confidence, root cause translation error. No approved justification for Mexico · Veltrimab §4.6, and no HA-mandated text in the library. The version history shows why: IPP v3 (Feb 2026) said 18 semanas; the number changed in the v4 translation round (Sep 2026).
Click any citation to open the source page with the passage highlighted — here the IPP, page 7.
Maya presses “Confirm critical”. The Labeling Committee is alerted, and task REM-MX-01 goes to Diego Navarro with a correction due Nov 6. The Remediation Drafter has written the corrected Spanish sentence from the CCDS and the translation memory, ready for the affiliate to submit.
“Las mujeres en edad fértil deben utilizar un método anticonceptivo eficaz durante el tratamiento y durante al menos 18 semanas después de la última dosis.”
§4.7: the CCDS says Veltrimab has no or negligible influence on driving; the IPP adds “se recomienda precaución al conducir u operar maquinaria”. Rule R-05 makes it a minor, unjustified deviation. Maya confirms it, and REM-MX-02 waits for the next routine update. The prescription-sale legend was accepted by rule — an exact match to HA-MX-001.
With every item decided, Maya signs the review. The sign-off lists the three register entries and their outcomes — task REM-MX-01, task REM-MX-02, HA-MX-001 — and records the meaning of her signature with it.
“I confirm every deviation in this label is classified, each justified deviation has its reason on file, and each unjustified or critical deviation has a remediation task.”
DEV-MX-08 and DEV-MX-09 now sit in the deviation register as signed, with the CCDS meaning, the local wording, the class, the root cause and the task. Maya asks Sam Patel, who signs the register for labeling compliance, to sign it before the Nov 20 inspection-readiness review; the register exports in one step.
The same Mexico IPP, seen by the four people who carry it — from the assessor who decides to the affiliate who files the fix.
Specialist agents read, translate, align and classify every local label and draft each fix; a medical risk assessor decides every deviation.
Reads each local label where it lives — document type, language, version, sections and pages — and links it to the CCDS version it should follow.
Writes an English reading of the label using the translation memory and the labeling glossary, sentence by sentence; the original stays the source of truth.
Splits the CCDS and the local label into meaning units and aligns them, even when the local template reorders or merges sections; reports missing meanings and local additions.
Classifies each aligned pair as aligned, justified, unjustified or critical with the medical-risk rules, and says which rule fired.
Checks each deviation against the justification register and the HA-mandated text library; exact matches are accepted by rule, near matches are shown to a person.
Drafts the corrected local sentence in the label language and opens a remediation task for the affiliate with the clock that the risk class sets.
Decides and signs. The agents propose; a named person decides.
Ask about any local label, deviation or justification — or tell it what to change. Answers cite the CCDS and the local page.
Which critical deviations are still open?
Four are waiting for you: Brazil §4.4 liver monitoring, Argentina §4.3 contraindications, Türkiye §4.2 Crohn’s dosing and China §4.4 live vaccines. The China clock ends today.
Why is the Brazil liver-test sentence critical?
The CCDS asks for liver enzymes and bilirubin at baseline and monthly up to week 12, and to interrupt treatment if liver injury is suspected. The Brazil bula v7 keeps only “no início do tratamento” — at the start of treatment. Two safety steps are missing, so rule R-01 makes it critical. Bula v6 still had the full sentence; it was shortened when v7 was reformatted. No justification is on file.
What did the Mexico leaflet get wrong?
Three findings in the Mexico IPP v4. The critical one: contraception after the last dose is “al menos 8 semanas” where the CCDS says at least 18 weeks — the number changed in the v4 translation round. A driving caution was added without a source (minor), and the prescription legend is justified by HA-MX-001.
Add a rule: a dropped anaphylaxis term is always critical
Done. Rule R-08 is on: when §4.8 no longer names anaphylaxis, the deviation is critical and goes to the Labeling Committee. It reclassified the open items where the term is missing, France among them. The rule is in Settings and in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
The classification rules, approvers and clocks are settings your team owns.
| Setting | Default | Choose from |
|---|---|---|
| Classification rules | 8 rules, R-01 to R-07 and R-01b, all on | Turn each on or off · add a rule by asking the assistant |
| Accept exact matches to the register by rule | On | On · Off |
| Send to a person below this confidence | 0.80 | 0.75 · 0.80 · 0.85 · 0.90 |
| Confirm a critical deviation | Dr. Maya Chen, medical risk assessor | Dr. Maya Chen · Lena Ortiz · Sam Patel · Omar Haddad · Dana Okafor |
| Approve a new justification | Lena Ortiz, global labeling lead | Dr. Maya Chen · Lena Ortiz · Sam Patel · Omar Haddad · Dana Okafor |
| Sign the deviation register | Sam Patel, labeling compliance | Dr. Maya Chen · Lena Ortiz · Sam Patel · Omar Haddad · Dana Okafor |
| Escalate a critical deviation to the Labeling Committee | 2 business days | 1 · 2 · 3 business days |
| Submit the correction — critical | 30 days | 14 · 30 · 60 days |
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 labels for a fictional product · “target” = the design goal, measured in the live solution · “estimated” = the solution’s own estimate of people time · “typical” = published figures (a published label-deviation audit case study: about 100 countries, 18 months). People, companies and products named on this page are fictional — characters and sample data in the working solution.
A check of each country’s label — SmPC, prescribing information, bula, package insert, monograph or leaflet — against the Company Core Data Sheet (CCDS), recording every place the local text says something different, why, and what will be done about it. The result is a deviation register you can show an inspector.
The Label Translator writes an English reading sentence by sentence, using your translation memory and labeling glossary, and the Meaning Aligner pairs each CCDS meaning with the local sentence that carries it, wherever the local template puts it. The original text stays the source of truth and is always shown beside the reading.
The Deviation Classifier applies your medical-risk rules — for example, a missing contraindication, warning or monitoring step in §4.3–4.4, or a changed number in a dose, interval or duration, is critical — and says which rule fired, with a confidence. The Justification Matcher then checks the justification register and the HA-mandated text library, so required national text is recognised as justified.
Yes. The agents propose; a named medical risk assessor confirms, downgrades or accepts each deviation, and no critical item is closed by an agent. Anything below the confidence threshold goes to a person, near matches to the register are never applied automatically, and the label review and the register are each signed.
No. Labels are read in place from the labeling repository, read only. The Remediation Drafter drafts the corrected local sentence and opens a task for the affiliate, who submits the correction.
The Labeling Committee is alerted, the affiliate owner gets a remediation task with the corrected local text drafted, and the correction is due on the clock the risk class sets. Both the escalation window and the correction clocks are settings.
Your labeling repository, CCDS library, translation memory and labeling glossary, plus the justification register and the HA-mandated text library. It produces the deviation register, cited side-by-side comparisons, remediation tasks and a compliance dashboard.
The Agentic Solution Engine builds and deploys it from your requirements — your CCDS, a sample of local labels, your justification register and your classification rules — and it goes live once every quality gate has passed. We will walk you through it on your own labels first.
Every agency change reaches the right team within hours, translated and cited.
1-min filmSubmission SummariesModule 2 summaries drafted in weeks, every statement cited to its source page.
1-min filmAgency ResponsesEvery agency question gets a cited first draft within hours, consistent with every past answer.
1-min filmWe’ll run the Local Label Deviation Auditor on a sample of your own local labels and your CCDS.