botminds.aiRequest a demo
SystemQuality & Labeling

UDI Data Reconciliation (GUDID and EUDAMED vs Label)

GUDID, EUDAMED and the ERP item master read against the released label artwork, so a wrong value is corrected for its whole family and signed by a steward who opened the sample.

See the demoBook a demo
Follow one MR Unsafe symbol from line-up to signature ↓
Watch with transcript →
The problem

A label that says MR Unsafe and a database record that says nothing about MRI

One device fact lives in the product lifecycle system, the ERP item master, the labeling system, GUDID, EUDAMED, China's UDI database and the instructions for use. When a label template changes, each team updates its own system from its own copy, and the field that feeds the GUDID load keeps its old default.

Submission validators check that a record is complete and well formed. They do not open the label. A mismatch turns up by accident, in a hospital's item master or a data pool rejection, and gets fixed one identifier at a time while the rest of the family carries the same error. Past the grace period, a fix done the wrong way creates a device identifier that should not exist.

Built forUDI data stewardsMaster data analystsLabeling specialistsRegulatory affairs teams

The Problem Today

The same device fact sits in six systems, and each team updates its own system from its own copy.

5.26M
device identifier records in the public US database published
28 Nov
2026: last day to register devices already on the EU market published

Compared by hand today

  • Labels
  • ERP
  • GUDID
  • EUDAMED
  • Records lock after the grace periodA published GUDID record is hard to edit once it closes
  • One fix, never the familyRecords that share a cause are found one at a time

The Solution

  1. The label read as the truthEach symbol on the released artwork becomes an anchor, cited to its spot
  2. Each system lined upEach attribute compared under the symbol it describes
  3. The cause traced to a familyOne finding becomes a batch of the identifiers that share its cause
  4. People approve and submitThe steward opens a sample and signs; labeling checks; a person submits

Built-in controls

  • Agents never submit to any database
  • Approval waits until each sampled record is opened
  • No edit drafted where a new identifier is needed

What You Get

Database records an auditor can trace to the released label, with a signed reason for each change.

12,500
hours a year of cross-checking off people, at a sample maker our estimate
  • EU registrations unblockedMismatches cleared before records go to the EU database
  • Whole catalog read overnightEach active identifier compared with its approved label
  • Each fix read backThe published value checked after a person submits
One symbol, seven systems

A GUDID record that missed the MR Unsafe symbol, and 140 records like it

Friday's overnight sweep read 100,240 active identifiers and found 4,812 mismatches on 2,906 of them. The master data analyst starts on Tuesday with a bidirectional ablation catheter.

demoThe manufacturer, its catheters, the people, the identifiers and the counts are sample data.

  1. 0107:40

    Seven anchors from the label, seven systems under them, nothing read yet

    Master data analyst

    The released artwork sits across the top as seven anchors: sterile EO, do not re-use, not made with natural rubber latex, MR Unsafe, use-by date, quantity one, keep dry and away from sunlight. Under each anchor sits a row per system, from product lifecycle to the IFU. Each cell reads not read yet until the agents run.

  2. 0207:41

    Three values fall out of line, and two sit under MR Unsafe

    Master data analyst

    Six agents run in order and compare 60 attributes. GUDID holds that the labeling does not contain MRI safety information. The ERP field that feeds the GUDID load reads NOT LABELED. EUDAMED's storage text says keep dry and leaves out keep away from sunlight. The other cells agree with the label, each with its source.

  3. 0307:41

    The GUDID value predates the template that added the MR Unsafe symbol

    Master data analyst

    He opens the GUDID cell. The record, the field, the value held and what the label says sit together: MR Unsafe, at position 4 of the symbol row, added by template rev C. The agent's reading says the record should read MR Unsafe, with a confidence of 0.97 labeled as sample data. Nothing changes until people agree.

  4. 0407:42

    Each correction drafted in its own database's field and wording

    Master data analyst

    Because the label did not change the device, this is an error correction and no new identifier. Past its 7-day grace period, the GUDID record is opened for edits by the coordinator for 5 calendar days. An ERP change request stops the next load from overwriting the fix. EUDAMED storage is updated in place. China's database maps no MR field, so nothing is drafted there.

  5. 0507:42

    One template revision explains 141 identifiers and 282 corrections

    UDI data steward

    The sibling finder followed template LT-EP-04 rev C to five electrophysiology catheter families, all with the same two gaps. For a batch of 150 identifiers or fewer, the rule in force draws 5 records, and it leaves out the one the analyst already read. Approve stays locked until she opens the sample. No timer opens it.

  6. 0607:51

    Each sampled record puts the artwork beside the drafted value

    UDI data steward

    A sampled decapolar catheter shows its identifier, its label template, what GUDID and the ERP hold now and what is drafted, and the released artwork with the MR Unsafe symbol at position 4. A record counts as opened after 3 seconds and her verdict: matches the label, or does not. Her opens count for her alone.

  7. 0707:55

    Approved after five opens, and the batch moves to the labeling check

    UDI data steward

    She signs as herself, with her own user ID and password. The meaning reads: approved, I opened the 5 sampled records and approve these 282 corrections for submission. The step bar moves on, and the screen says the labeling specialist must open each record herself before she can sign. Five green lines show how long each record was open.

  8. 0808:02

    Labeling opens the same five against the artwork and signs a separate check

    Labeling specialist

    Her opens are logged under her own session. She signs checked against the approved label, with the reason that the sample matches the released artwork. Two people have now signed the batch for two different things, each with a session code. The next step names the regulatory affairs specialist, and the ERP part waits for the analyst to post.

  9. 0908:05

    The button to submit 141 GUDID edits is hers, and no agent presses it

    Regulatory affairs specialist

    Approved and checked, the batch shows one button on her screen. Once she submits, the submission tracker reads back each acknowledgment and the published value, and reopens any record that did not land. The EUDAMED storage fix travels in its own batch, and the analyst posts the 141 ERP changes from his queue.

An edit, or a new identifier: how the rule checker decides

The change rule checker applies these before anything is drafted. Where a new identifier is needed, nothing is drafted and a person owns the route.

What happenedGUDIDEUDAMED
The label changed the version, model or package quantityNew device identifier (21 CFR 830.50)New UDI-DI
The label did not change; the database holds a wrong valueError correction: the record is reopened for 5 calendar daysCorrect the record in place
MRI safety status wrong, label unchangedError correction, record reopenedNo EUDAMED element
Storage and handling, GMDN or EMDN code, contact, instructions addressEdit in the grace period, or error correction after itUpdate in place
China's record wrong, label unchangedNoneChina's own correction procedure, through the registration agent

demoSample data, from the working solution. A label change to single use, sterile packaging, latex or quantity per package needs a new identifier, so those findings go to a person with no draft.

Five catheter families share template rev C, and batch B-14 holds them all

The sibling finder follows the cause, not the product name.

Irrigated ablation catheters22
Steerable decapolar diagnostic catheters36
Fixed-curve quadripolar diagnostic catheters44
Circular mapping catheters24
Non-irrigated ablation catheters15
Identifiers in batch B-14141
Corrections: one GUDID edit and one ERP change for each identifierOpen mismatches go from 4,405 to 4,123 once all 282 are read back.282

demoSample data, from the working solution.

Around the batch

Mismatches, rules and queues behind the UDI data steward's sign-off

What the analyst, the steward and regulatory affairs open between line-ups.

4,812 mismatchesGrouped by attribute and by where the wrong value sits, each with its cause, owner, clock and batch. MRI safety status alone holds 612.
Edit or new identifierThe GUDID and EUDAMED rules side by side, each cited, with three worked cases from this sample.
100,240 identifiers87,310 in GUDID, 61,880 on the EU market and 18,450 in China's database. 412 EU registrations wait on an open mismatch.
The EU representative's viewRead only: EU registrations, open EU corrections and the days left to register. Corrections are approved by the steward and submitted by regulatory affairs.
Work queuesEach person's queue, its oldest item and its clock, from 3,327 mismatches in triage to 23 quantity changes that need a new identifier.
Audit trailEach open, approval and check with its session and the meaning of the signature, exported as CSV or JSON.

demoSample data, from the working solution.

Who reads the label

Seven agents compare the label with each database; a person submits

The approved label is the source of truth, and people decide what goes out.

Label reader

Reads the released artwork and IFU and lists each symbol and statement with its place.

  • Never reads unreleased artwork
  • Never decides when the label is silent
Record gatherer

Pulls the identifier's record from each system and database.

  • Never writes to any system
Attribute matcher

Maps each system's field and value to the label's meaning and compares them.

  • Never treats a typed value as matched
  • Never reads not held as matched
Change rule checker

Decides whether a change is an edit or needs a new identifier, from the loaded rules.

  • Never drafts an edit where a new identifier is needed
Correction drafter

Writes each correction in the target database's own field and wording, and the ERP request.

  • Never submits anything
Sibling finder

Follows a cause, such as a template revision or an ERP default, to each identifier sharing it.

  • Never adds an identifier without the shared cause
Submission tracker

Reads acknowledgments and the published record after a person submits.

  • Never resubmits
  • Reopens what did not land

Submissions, new identifiers and silent labels stay with named people

The agents draft from the label. These calls belong to a person.

Submitting to GUDID, EUDAMED or China's databaseRegulatory affairs presses send, after the steward's approval and the labeling check.
A change that needs a new device identifierNothing is drafted; regulatory affairs and labeling own the route.
A label that is silent, or disagrees with its IFUThe labeling specialist decides, and can place a print hold.
The largest batchesBatches over a set size need the director of regulatory operations' second approval.
Rules for sampling and approvalThe administrator proposes a change; the director signs it before it takes effect.

What UDI data stewards ask about GUDID corrections

What does GUDID data reconciliation check?

It checks that GUDID, EUDAMED, China's UDI database and the ERP item master say what the approved label says. This GUDID reconciliation reads the released artwork and IFU, lines up each system's value under each symbol, and drafts corrections for people to approve and submit.

Does it submit corrections to GUDID or EUDAMED?

No. The steward approves after opening a sample, the labeling specialist checks it, and regulatory affairs submits. The submission tracker then reads back the acknowledgment and the published value.

What happens when a change needs a new device identifier?

The change rule checker marks it and nothing is drafted. The finding goes to regulatory affairs and labeling, who own the new identifier.

How can a steward approve a large batch without opening each record?

The rule in force draws a sample by batch size and leaves out records already examined. Approval stays locked until each sampled record is opened and given a verdict, and the largest batches need a second approval from the director.

Does it handle HIBCC identifiers as well as GS1?

Yes. Both issuing agencies' identifiers sit in the inventory and are read against their labels, and search matches GTINs, HIBCC codes, catalog numbers and Basic UDI-DIs.

Why does the ERP item master matter?

It feeds the GUDID load. A default left in an ERP field overwrites a corrected GUDID value on the next load, so each GUDID fix comes with an ERP change request.

Quality & Labeling

Other labeling and registration work for device makers

All 4 solutions →
CAPA Effectiveness Verification

Every closed CAPA proved with its own sums, and the same cause found where the fix never went.

1-min demoNonconformance (NCMR) Investigation and MRB Disposition

Every MRB call made on the records, not on memory, with each seat's signature.

1-min demoFDA 483 and Warning Letter Response

Every promise to FDA has an owner, a date and its proof.

1-min demo

Send us one label template
and the identifiers printed with it.

We will line up what each database says under its symbols and show which values drifted.

Book a demoBrowse solutions