Label and artwork management, regulatory data, destination labeling and serialization in a single validated platform: from a single plant to a global enterprise.
Where it hurts
Not a feature list. These are the three things that make regulated labeling expensive, and what RONOVA does about each.
A single label change touches artwork, product data, translations and templates. Reconstructing what actually changed, and why, means reading back through email.
Change management captures the reason for a change at the moment it is made, and links every object altered as part of it. The change set is one record rather than a trail to reassemble later: what changed, why, who approved it, and what moved with it.
An inspector asks who approved this label, when, and on what basis. The answer is spread across systems, or in somebody's memory.
Every user action and every change is recorded against a person, a time and a reason, with electronic signature for 21 CFR Part 11. The history is the evidence: it does not have to be assembled for an audit, because it was never kept anywhere else.
Production printing never quite matches the workflow a vendor assumed. So the system gets worked around at the line, and the controls get worked around with it.
Fully configurable, web-based printing workflows built to match the production printing process a plant already runs: rather than a fixed sequence the floor has to adapt to, or abandon.
Labeling sits at the end of the process, after everything else has been validated. It is where a wrong translation, an out-of-date instruction or an unapproved artwork revision reaches the product, and a large share of device recalls trace back to exactly that.
The United States, the European Union, Brazil and China each define their own identifiers, data sets and language requirements. Managed separately they diverge, and the divergence surfaces as a rejected submission or an inspection finding.
In a validated environment every change carries qualification effort. Systems that make change cheap by making it uncontrolled are not an option, so the control model has to be designed in rather than layered on.
Label and artwork management
Artwork, text and review in the same controlled system that approves and prints the label.
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.
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.
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.
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 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.
Capabilities
Store assets, design and edit artwork, mark up for review, check compliance and track every version of every label, in one controlled system.
Read moreOne master record for product and regulatory attributes, so the label, the artwork and the ERP cannot disagree with each other.
Read moreMarket-specific language, symbols and regulatory content applied automatically by ship-to destination, from one approved template.
Read moreUnique serial numbers issued, applied and recorded under the same change control as the rest of the label, at production line speed.
Read moreElectronic instructions for use, published to a regulator-compliant portal and versioned in step with the printed label.
Read moreFull genealogy from incoming material to shipped unit, queryable for the product's regulatory retention period.
Read moreHow RONOVA deploys and fits an existing stack: hosted cloud or private cloud, integrated with ERP, MES and PLM.
Read moreValidated by design
Compliance is not a module. The control model (who may change what, and what evidence that leaves) is the architecture.
Electronic records and signatures, with enforced re-authentication.
Label and instructions-for-use content, symbols, and language per destination.
Portuguese and Simplified Chinese content, with carriers at every packaging level.
Risk-based validation and IQ/OQ/PQ documentation, delivered against Innovatum's ISO 9001:2015 certified quality system.
Every change attributable to a person, a reason, and a timestamp.
Ingredient, allergen, and nutrition declarations that follow the recipe.
Hazard pictograms, signal words, and precautionary text from one classification.
Per-customer transport and part labels resolved from one shipment record.
RONOVA is built for 21 CFR Part 11 compliance, with electronic signatures, immutable audit trails and role-based access control, and the same controls satisfy equivalent expectations under EU Annex 11, EU MDR, NMPA and ANVISA oversight. Innovatum supplies IQ/OQ/PQ documentation and validation support, and Innovatum's own quality system is certified to ISO 9001:2015. Validation is always for intended use, so qualification is completed against the customer's own configuration.
Nothing has to happen: ROBAR is still supported and still sold, and there is no forced migration. If you do choose to move, RONOVA is reached on a supported path that carries across label templates, master data and approval history, with Innovatum handling the migration and the revalidation so an existing configuration is not rebuilt from scratch. Whether the move is worth making depends on your estate, which is a conversation rather than a deadline.
RONOVA integrates with SAP, Oracle and other ERP and MES systems through documented APIs and message-based interfaces. Product and order data flows from the system of record into labeling without manual re-entry.
Yes. The same validated path to release applies whether one plant prints labels or two hundred do. A single-site manufacturer gets the same control model without the multi-site coordination it does not need, and the system scales as sites are added rather than being replaced.
Watch how easy it is to configure custom web-printing workflows.