Platform
Regulatory and Product Data.
The same attributes appear on the label, in the regulatory record, in the ERP and in the quality record. Maintained separately, they diverge quietly. The cost is rarely the original error; it is the reconciliation work and the audit exposure that follow it.
What it does
One attribute, one owner.
Each regulatory and product attribute has a single authoritative value and a defined owner. Downstream uses reference it rather than holding their own copy.
Market-specific values where they genuinely differ.
Some attributes legitimately vary by market. The record carries those variants explicitly, rather than forcing a choice between one wrong global value and a separate record per market.
Change control on data, not just documents.
A regulatory attribute change is a controlled event with review and an audit trail, in the same way a template change is.
Feeds the label and the filing.
The printed label and the registry submission both resolve from this record, so they cannot state different things about the same device.
How it works
Attributes defined once, centrally.
The data model covers the attributes labeling and submissions actually need: identifiers, classifications, sterilisation and storage conditions, contents, market authorisations.
Populated from the system of record.
Where an attribute already lives authoritatively in ERP or PLM, it flows in rather than being re-entered, so there is one source and not a second copy to reconcile.
Validated on entry
Values are checked against the format each target market requires at the point of entry, rather than failing later at submission when the cost of correction is higher.
Consumed by every downstream use.
Labels, submissions, eIFU content and reports all read the same record. A correction propagates to all of them from one change.
Regulatory context
What this speaks to.
The regulations and standards this capability is built against. Always check the current text of any regulation before relying on it.
- FDA GUDID: device identification data
- EU EUDAMED: Basic UDI-DI and device registration
- ANVISA RDC 591/2021: Brazilian UDI data
- NMPA UDI: Chinese device identification
- 21 CFR Part 11: attributable, time-stamped change records
Questions about this capability.
Does this replace our ERP or PLM system?
No. It holds the regulatory and labeling view of the product and takes authoritative values from ERP or PLM where those already exist. The aim is one source per attribute, not a second system competing with the first.
How are attributes that differ by market handled?
As explicit per-market variants on the same product record. That keeps one product record while allowing an identifier, a classification or a storage statement to carry different values in different jurisdictions.
Related capabilities
Label Management
Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.
Destination Labeling
Market-specific language, symbols and regulatory content applied automatically by ship-to destination, from one approved template.
Stop guessing why a label changed.
See linked object impacts and change reasons captured in one click.