Every Label Checked.Every Risk Caught Before Print.
Agents check every draft label, carton and insert against your source documents, the regulations and the products already on the market. Each finding shows its evidence, and your labeling team decides every change before it ships.
Checked against the approved label v12, the SPL listing and 4 marketed products
A sample carton under review. All names, products and numbers are made up.
Four Checks on Every Label
Each draft is checked the same way, from the first carton mock-up to the final insert. Each check below opens the screen your labeling team works in.
- SourceLabel TextEvery statement checked against its source.
- MarketComparator ReviewNames, colors and layouts compared with marketed products.
- EvidenceLabel UpdatesSafety changes drafted into the label with their sources.
- VersionsChange ControlEvery version compared, every change approved.
- RiskRisk MinimizationLook-alike, sound-alike and wording risks flagged early.
Every Statement Checked Against Its Source
Prescribing information, patient leaflets and instructions for use are read statement by statement. Agents match each one to the core data sheet, the approved label and the market, and flag what changed, what is broken and what reads too hard.
Matched to Its Source
Rates, schedules and contraindications are checked against the integrated summary, the core data sheet and the approved label.
Compared With the Last Version
Every change since the approved version is tracked, including the ones nobody meant to make.
Written for Patients
Patient-facing sections are checked for reading level and plain language.
5. Warnings and Precautions
Changes since approved version 12 are tracked
5.1 Hepatotoxicity.
ALT above 3× ULN in 1.4% of patientsAI
Check liver tests every 4 weeksAI
5.2 Hypotension.
Do not use with other alpha blockersAI
5.3 Angioedema.
See Patient Counseling (17.3)AI
| Product | Similarity | Strength | Carton colors |
|---|---|---|---|
| Veltrazine (draft) | — | 20 mg | Navy, green |
| Valtrazide | 0.86 | 20 mg | Navy, green |
| Velmeprol | 0.62 | 10 mg | Orange |
| Teltrazine | 0.71 | 40 mg | Blue |
| Verazolin | 0.48 | 25 mg | Purple |
Compared With Every Product on the Shelf
A label is safe only if it cannot be mistaken for something else. Agents compare names, strengths, colors and layouts with marketed products, and flag look-alike and sound-alike risk before launch.
Names, Strengths and Trade Dress
Spelling, sound, strength and carton colors are compared with every product in the comparator set.
Medication Error Risk
Combinations that could lead to a dispensing or administration error are flagged with the reason.
Comparator Labels Kept Current
Comparator labels are refreshed as they change, so the comparison is never out of date.
Safety Changes Drafted Into the Label
When a safety assessment confirms a new risk, agents draft the label update from the evidence: the signal assessment, the core data sheet and the current label. Every sentence cites its source before the labeling committee sees it.
From the Evidence
Drafts use the signal assessment, the core data sheet and the current approved label, and nothing else.
Every Market at Once
The same change is drafted for each market’s label, with local differences kept.
The Committee Decides
Nothing is final until the labeling committee approves the wording.
Label Update · Section 6.2
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Veltrazine.4 Hepatobiliary disorders: cholestatic hepatitis, jaundice.12
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency.4 This wording matches section 4.8 of the core data sheet.3
Every Version Approved in the Right Order
Each label version follows a route you define, from author to regulatory to quality. Every signature is electronic, every version is kept, and the change from the last approved version is always one click away.
Routes You Define
Artwork, inserts and updates each follow their own route, set by an administrator without code.
Electronic Signatures
Each sign-off records who signed, when, and the meaning of the signature.
Every Version Kept
Drafts and approved versions are kept side by side, with every change between them.
Built for Labeling Teams
ThinkTrends runs in your environment, keeps a qualified person on every decision, and keeps your data out of model training.
Your Team Approves Every Change
Agents check, compare and draft. Your labeling team decides, and every approval is recorded under a name.
Your Data Never Trains a Model
Cases, labels, trial data and documents are used to do the work and nothing else.
Runs in Your Environment
Deploy in your cloud or data center, with patient and product data kept inside your boundary.
Validation Evidence Included
Each agent version is tested against your acceptance criteria, and the results are ready for your validation file.
21 CFR Part 11 Aligned
An audit trail no one can edit, electronic signatures with their meaning, and access by role.
Configured, Not Coded
Rules, routes, checks and thresholds are settings your administrators can read and change.
Related Modules
The platform modules these solutions are built on.
Frequently Asked Questions
Common questions about ThinkTrends Labeling Intelligence & Assurance.
What is ThinkTrends Labeling Intelligence & Assurance?
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ThinkTrends Labeling Intelligence & Assurance is agentic AI that checks draft labels, cartons, prescribing information and patient leaflets against your source documents, the regulations and products already on the market. Each finding shows its evidence, and your labeling team decides every change.
How is ThinkTrends different from RIM or artwork management systems?
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Regulatory information management and artwork systems track label versions and approvals. ThinkTrends reads the content itself: it checks every statement against the core data sheet and approved label, compares each version with the last and flags look-alike and sound-alike risk.
What does ThinkTrends labeling review check?
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Panel content against the regulations, every statement against the approved label and core data sheet, each version against the last one, and names and layouts against marketed products.
How does ThinkTrends find look-alike and sound-alike name risk?
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Names are compared by spelling and sound with every product in your comparator set, together with strength and carton colors, and risky combinations are flagged with the reason.
Does a ThinkTrends agent change a label on its own?
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No. Agents check and draft. Your labeling team decides every change, and only approved versions move forward.
Is our data used to train AI models?
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No. ThinkTrends uses labeling documents only to do the work, inside your own environment. Your data is never used to train, tune or evaluate a model.