Solutions by scale
Labeling across a global network.
At this size the problem stops being any single label and becomes consistency: the same product, labelled the same way, in every plant that makes it, provable to every regulator that asks.
This is you if…
Checkable statements rather than adjectives. If most of these are true, this is the right page.
- Plants on more than one continent, and at least one contract manufacturer printing your labels
- The same product sold into markets with different labeling rules
- An audit somewhere in your network at almost any given time
- More than one labeling system in use, because sites were acquired rather than built
- A change to one label that nobody can confidently say has reached every site
What makes it hard.
Divergence is invisible until it is expensive.
Two plants printing the same label from two systems will drift apart: a symbol here, a revision there. Nobody notices until a regulator compares them, and by then it is a finding rather than a fix.
Contract manufacturers are inside your quality system.
Their printing is your label and your liability, but they are outside your network and often outside your IT estate. Handing them a PDF and hoping is the common answer and the wrong one.
Every market wants a different label.
Maintained as separate label sets, the number of things that can be wrong multiplies by the number of markets, and each one has to be revalidated on its own.
The audit has to reconstruct the past.
Not the current state of a label but who changed what, when, and why, on a product that may have been in the field for a decade. Local records in local systems cannot answer that as one story.
What changes.
One record, every site.
The label is defined once and printed everywhere from that definition. A site cannot quietly hold a variant, because there is nowhere for a variant to live.
Contract manufacturers print from the same system.
Browser-based printing means an external site needs a login and a printer, not an installation and a copy of your data.
Markets are content rules, not label sets.
Destination-driven content resolves what a given market requires from the one record, so adding a market adds rules rather than another parallel label to keep in step.
One audit history, network wide.
Every action attributable and timestamped, with the reason captured at the point of change and electronic signature where 21 CFR Part 11 requires it: across all sites rather than per site.
Isolation you can point at in a questionnaire.
In the hosted service each customer runs in a logically isolated tenant database, and a private cloud is single-tenant. Either way it is an architectural answer to the first question your own security review asks.
The shape that fits
What it costs.
Many sites including contract manufacturers, high printer counts, and US, EU, Brazil and China in the same product record.
Approximate, and an annual subscription. The final figure depends on configuration: sites, users, printers and markets.
The capabilities that carry it.
Architecture
How RONOVA deploys and fits an existing stack: hosted cloud or private cloud, integrated with ERP, MES and PLM.
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.
Questions at this scale.
Can contract manufacturers print RONOVA labels?
Yes. RONOVA printing is browser-based, so a contract manufacturer prints from the same system and the same label record as your own plants, with their own users and permissions and without an installation on their estate. Their printing appears in the same audit history as everyone else's.
How does RONOVA handle several regulators for one product?
Through destination-driven content rather than parallel label sets. The product has one record, and what a given destination requires is resolved from it at print time, so US, EU, Brazil and China can be satisfied from the same source rather than from four label families that have to be kept in step by hand.
We have several labeling systems from acquisitions. Where does that leave us?
It is the common starting point at this size, and it is a migration question rather than a blocker. RONOVA is designed for data migration from existing label systems, and consolidation usually runs site by site rather than as a single cutover, so a plant moves when its validation window allows.
Is RONOVA multi-tenant, and what does that mean for our data?
In the hosted service RONOVA is multi-tenant, and each customer runs in a logically isolated tenant database rather than sharing tables with other customers. RONOVA also runs in a private cloud, which is single-tenant by definition and is the route for data residency requirements. Ask for the hosting detail behind whichever model you are considering: it is the part your own questionnaire will want in writing.
Other shapes
- Growing CompaniesStart at one site with the full control model, and grow without a re-implementation.
- Multi-Site OperationsOne record and one audit history, with printing configured per site.
Change control, without the archaeology.
See how to execute game-changing labeling change control with automatic, end-to-end impact analysis.