Platform
Label Management
Most labeling problems are version problems. A template edited locally, an artwork revision that never reached the second plant, a translation updated in one market and not another. Centralising the template, the data and the approval removes the conditions those problems need.
What it does
Design once, deploy everywhere.
A single template serves every site that prints the product. Layout, symbols and variable fields are defined centrally, so a change reaches every location at the same moment rather than site by site.
Electronic approval before release.
A label cannot reach production without the reviews its change type requires. Approval is an electronic signature bound to a named person, a reason and a timestamp, given with a password or single sign-on, and the routing for a recurring change type is saved rather than rebuilt each time.
Versioning with full history.
Every revision is retained, not overwritten, and each step it passes through (drafted, checked out for editing, checked back in, promoted) is written to the label's own history as it happens. The version in force on any past date can be retrieved, which is what makes a batch record defensible years later.
Print without re-entry
Variable data (lot, expiry, serial, destination) arrives from the system of record rather than being typed at the line, removing the most common source of label error.
How it works
Template holds structure, not content.
The template defines where information goes and which rules govern it. The values come from the product record at print time, so one template covers every variant of a product rather than one template per variant.
Change triggers the workflow.
Editing a controlled template opens a change record. The system routes it to the required reviewers based on what changed: a regulatory content change and a layout tweak do not need the same approvals.
Approval releases the version.
On final signature the new version becomes the one available to print. The previous version is retained and remains retrievable.
Printing draws from the approved set.
Production requests a label for a product and destination; the system resolves which approved template and content apply. Operators do not choose a template, so they cannot choose the wrong one.
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.
- 21 CFR Part 11: electronic records and electronic signatures
- EU Annex 11: computerised systems
- EU MDR / IVDR: label content and symbols
- ISO 15223-1: symbols for medical device labels
- GAMP 5: risk-based validation
Questions about this capability.
Can a label be printed without going through approval?
No. Only approved template versions are available to production. An unapproved draft cannot be selected at the line, which is the control that makes the audit trail meaningful rather than advisory.
What happens to labels approved under the previous version?
Previous versions are retained in full, not overwritten. A batch produced last year remains linked to the template version in force at the time, so the label that shipped can be reproduced exactly during an inspection or investigation.
Related capabilities
Regulatory Data
One master record for product and regulatory attributes, so the label, the artwork and the ERP cannot disagree with each other.
Destination Labeling
Market-specific language, symbols and regulatory content applied automatically by ship-to destination, from one approved template.
Traceability
Full genealogy from incoming material to shipped unit, queryable for the product's regulatory retention period.
Ditch the change-tracking spreadsheets.
Witness the power of fully unified, relational change management.