Platform
Label and Artwork Management.
RONOVA is enterprise label management for life sciences, and label and artwork management is its core: one controlled source for assets, templates, data and approval. 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 artwork, the template, the data and the approval removes the conditions those problems need.
What does RONOVA label and artwork management include?
A managed library of digital assets.
Images, icons, symbols and completed designs are stored and organised in one controlled library, so every label draws on the approved version of an asset rather than a copy saved on somebody's drive.
Design and edit text and artwork.
Users design and edit the text and artwork on product labels and packaging inside RONOVA. A single template serves every site that prints the product, so a change reaches every location at the same moment rather than site by site.
Markup for review and feedback.
Reviewers mark up a design directly, with lines, boxes, arrows and text, to show exactly what needs to change. Markups are saved with the review, visible to the other reviewers, and sent to the change owner to resolve.
Compliance checks before release.
Labels are checked against regulatory requirements before they are approved, through automated checks or compliance checklists built into the review, so a missing symbol or statement is caught in review rather than at inspection.
Every version of a design, logged.
Every change or update to a design is logged and every revision is retained, not overwritten. Each step a version passes through (drafted, checked out for editing, checked back in, promoted) is written to its history as it happens, and the version in force on any past date can be retrieved.
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.
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 does label approval and release work?
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
Which regulations is label and artwork management built against?
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.
Does RONOVA include artwork management?
Yes. RONOVA manages label artwork alongside the label itself: it stores and organises digital assets such as images, icons and completed designs; lets users design and edit the text and artwork on labels and packaging; gives reviewers markup tools to collaborate and give feedback on a design; checks labels against regulatory requirements through automated checks or compliance checklists; and logs every change, so each version of a design is tracked.
How do reviewers give feedback on a label design in RONOVA?
With markup. During review, a reviewer draws directly on the design (lines, boxes, arrows and text) to show what needs to change. The markup is saved with the review, other reviewers can see it, and it goes to the change owner to resolve, so feedback stays attached to the change rather than scattered across email.
How does RONOVA check that a label meets regulatory requirements?
Compliance is checked during review, before a label can be approved, through automated checks or compliance checklists that reviewers complete. Combined with electronic approval, that means a label reaches production only after the required content has been checked and signed for.
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.