One validated system for label design, approval, and regulatory data: meeting FDA, EU MDR, NMPA and ANVISA labeling requirements from a single plant to a global network.
Every customer has agreed to act as a reference, and every one has renewed, year after year. Learn more about our record.
The problem
Most manufacturers still run labeling as a chain of disconnected systems: artwork in one tool, regulatory data in a spreadsheet, approvals in email, and market content rebuilt by hand for every destination. Every handoff is a place where the label and the truth can diverge, and every market you add multiplies the handoffs.
RONOVA closes the gap. One source of regulatory and product data drives the label, the artwork, and the electronic IFU, so what prints, what ships, and what the regulator sees are the same record, whether that regulator is in Washington, Brussels, Beijing, or BrasÃlia.
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.
Every market you sell into
Each market defines its own identifiers, its own database, and its own language requirements. RONOVA holds them as configuration, not as four parallel processes your team maintains by hand.
Label content, symbols and UDI carriers under FDA rules, with electronic records and signatures under 21 CFR Part 11.
Label content in every language a member state requires, with UDI carriers and symbols under EU MDR and IVDR.
UDI coding at the smallest sales unit and Simplified Chinese content on the label, phased across device classes.
UDI carriers on the label and every packaging level under RDC 591/2021, in Brazilian Portuguese.
Deployed at every scale
One plant, one market, and a quality system that still has to hold up to an inspection.
1 site
Shared templates and one master record across plants, without each site drifting into its own process.
3+ sites
Dozens of sites and every regulated market, with regional requirements applied automatically.
Dozens of sites
The platform
Validated by design
Compliance is not a module bolted on at the end. Every action in RONOVA is attributable, timestamped, and reconstructable, because that is what an inspector asks for, in whichever jurisdiction they arrive from.
Already running a labeling system?
Templates, master data, and approval history migrate across. Innovatum handles revalidation. That applies whether you are on ROBAR, another labeling platform, or a stack of spreadsheets and workarounds.
Questions
Still unsure? Talk to someone who implements this.
RONOVA is Innovatum's enterprise label management platform for life sciences manufacturers working in validated, regulated environments. It addresses three problems that make regulated labeling expensive: change management, by capturing the reason for every change and linking every object that change alters; auditability, through a complete history of user actions and changes with 21 CFR Part 11 electronic signature; and production fit, through fully configurable web-based printing workflows that match the process a plant already runs. Label design, regulatory data, destination labeling and serialization all resolve from the same product record. It is the successor to Innovatum's ROBAR platform.
Yes. 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 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.
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 runs as a hosted cloud service or in a private cloud. It is used through a browser, including printing, so there is no client software to install on the plant floor. Regulated manufacturers with data residency requirements can keep the system in a dedicated environment.
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.
RONOVA supports labeling for the United States, the European Union, China, and Brazil, along with other markets on request. Market-specific identifiers, symbols, and language requirements are held as configuration rather than as separate processes, so adding a market does not mean adding a parallel workflow.
Yes. RONOVA assigns NMPA UDI codes at the smallest sales unit and carries them on the label and every packaging level, with Simplified Chinese content resolved by destination. This matters more in China than in most markets because UDI data is a prerequisite for product registration, renewal, and modification, so the identifiers have to be right before anything else can proceed. NMPA coverage is phased across device classes through 2029.
Yes. RONOVA applies UDI carriers to the label and every packaging level as required by ANVISA under RDC 591/2021, as amended by RDC 884/2024. Brazilian Portuguese label content is handled through the same destination labeling rules used for every other market.
No. RONOVA is used by single-site manufacturers and by global networks running dozens of plants. The term enterprise labeling describes the software category, not a minimum customer size. Deployment scope, validation effort, and cost scale with the number of sites, label complexity, and markets in play.
Label content is stored per market and applied automatically by ship-to destination, covering the up to 24 official languages the European Union may require, Simplified Chinese for China, and Brazilian Portuguese for Brazil. Translations are versioned and approved through the same audited workflow as the rest of the label, so a translation change is traceable like any other change.
Implementation timelines depend on the number of sites, label complexity, and validation scope. A single-site deployment is typically measured in weeks; a multi-site global rollout is planned in phases. Innovatum scopes the timeline during evaluation rather than quoting a fixed figure.
