FAQ
Questions, answered in full.
76 questions, gathered from across the site. Each answer is the same one that appears on the page that owns the subject: this page does not keep a second, shorter version.
About RONOVA
What it is, who it is for, and how it is delivered. The platform
- Is RONOVA validated for regulated environments?#
- 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.
- We currently run ROBAR. What happens to our system?#
- 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.
- How does RONOVA integrate with SAP and other ERP systems?#
- 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.
- Does RONOVA suit a single site as well as a global enterprise?#
- 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.
Pricing
Published figures, and what moves them. Pricing
- Why publish prices at all when nobody else does?#
- Because the alternative wastes everyone's time. A buyer with a $40,000 budget and a buyer with a much larger one both currently have to sit through a discovery call to find out whether a conversation is worth having. Publishing where it starts means that question is answered before anyone picks up the phone.
- Are these figures fixed?#
- No. They are approximate starting points for each shape of deployment, in US dollars, billed annually. The final figure depends on configuration: how many sites, users, printers and markets are in scope. Scope is agreed before a quote is issued, so the number in a proposal is a real number rather than a range.
- Is it a subscription or a perpetual licence?#
- A subscription. RONOVA is licensed as an annual SaaS subscription, which covers the platform for the agreed configuration.
- What happens when we add a site or a market?#
- It changes the configuration, so it changes the subscription. The system itself does not need replacing: adding a site or a market is configuration rather than a new deployment, which is the point of the tiers describing scale rather than different products.
Compliance and validation
21 CFR Part 11, the equivalent expectations elsewhere, and what validation involves.
- Does RONOVA support electronic signatures under 21 CFR Part 11?#
- Yes. Electronic signature is part of the control model, bound to the action being signed and to the signer, alongside an immutable audit trail and role-based access control. Which steps in your process require a signature is configuration, because it varies by company and by product class.
- Can RONOVA satisfy EU, Brazilian and Chinese requirements as well as US ones?#
- The same controls (audit trail, electronic signature, change control with reason capture) address the equivalent expectations under EU MDR, ANVISA and NMPA oversight. What differs between those markets is label content rather than control, and content is handled by destination-driven labeling from a single product record rather than by maintaining a separate label set per market.
- Can we require a signature on some actions but not others?#
- Yes. Signing is configured per action rather than applied uniformly, so the actions your procedures treat as significant require a signature and routine ones do not. Where a signature is required you can also require a reason code, a comment, or both, and users sign with either their password or their single sign-on identity.
- How are label approvals routed to reviewers?#
- Reviewers are grouped against the change, and a routing you use repeatedly is saved as a template so a recurring change type does not have to be assembled by hand each time. The outcome is kept with the change rather than in someone's inbox: who approved, who rejected, when, and the reason given.
- Who is responsible for compliance, us or Innovatum?#
- Both, and the split matters. Innovatum is responsible for the software's controls and for the validation evidence that the software does what it claims, including IQ/OQ/PQ documentation and validation support. You remain responsible for the procedural half: authorisation, training, deviation handling and periodic review. No software product can discharge a regulated company's own obligations.
- Is Innovatum's quality system certified?#
- Yes, Innovatum holds ISO 9001:2015 certification covering its software development and support processes, and the certificate itself is published rather than merely claimed. Innovatum is also a member of RAPS, the Regulatory Affairs Professionals Society, and of AIM Global, both of which are independently checkable in those organisations' own supplier directories. Ask for the current certificate with its expiry date for your supplier file.
- Does Innovatum supply IQ/OQ/PQ documentation?#
- Yes. Innovatum supplies IQ/OQ/PQ documentation and validation support for RONOVA. Ask during evaluation which documents are templates you execute and which Innovatum executes and hands over, because that split is what determines your internal effort.
- What happens to our validated state when RONOVA is updated?#
- That depends on the release and on what your configuration actually uses, which is why change control matters: because every change records its reason and links the objects it alters, the impact of a change is a question the system can answer rather than an assumption you have to make. Ask Innovatum for the release cadence, the notice period and the regression evidence that accompanies a release. Those three decide the ongoing cost of a validated deployment far more than the size of the initial package does, and they are the right thing to settle before signing rather than after.
- Do we have to revalidate everything when we change one label?#
- No, and a system that made you do so would be unusable. Changes are made under change control with the reason captured and every affected object linked, so the scope of any revalidation follows what the change actually touched. Your own validation procedure sets where that line falls.
- Is validation different for a multi-site deployment?#
- The performance qualification covers each site's own process and printing, since that is what differs. What does not multiply is the installation: printing is browser-based and there is no local install per plant to qualify separately.
Security and deployment
Tenancy, hosting, integration, and what a deployment actually involves.
- Is RONOVA multi-tenant, and is our data mixed with other customers'?#
- In the hosted service RONOVA is multi-tenant, and each customer runs in a logically isolated tenant database: your records are not interleaved with another customer's in shared tables, because isolation is a property of the data model rather than a filter applied by application code. A private-cloud deployment is single-tenant, so the question does not arise there.
- Can we control who is allowed to approve and print labels?#
- Yes. Role-based access control governs who may design, review, approve and print, and signing authority is an explicit permission rather than an assumption. Every action is recorded in the audit trail, so the enforcement is also evidenced.
- Where is RONOVA hosted, and can we choose a region?#
- RONOVA runs as a hosted cloud service or in a private cloud, so a residency requirement can be met by the deployment model itself. The provider and regions behind the hosted option specifically should come from Innovatum in writing rather than from a marketing summary: ask for it early if EU, Brazilian or Chinese residency is a constraint.
- What uptime does RONOVA maintain?#
- Innovatum maintains 99.99% uptime. Ask for how that is expressed in the subscription agreement (how it is measured, what maintenance is excluded from it, and whether service credits attach) because an operational figure and a contractual service level are different commitments and only one of them is enforceable.
- Does Innovatum hold SOC 2 or ISO 27001?#
- Innovatum's quality system is certified to ISO 9001:2015. Any further independent assurance for RONOVA or its hosting should be requested directly rather than inferred from this page, and if a specific certification is a requirement for your organisation, raise it in the first conversation.
Migration
Moving from ROBAR, and moving off another vendor's system.
- Is ROBAR being discontinued?#
- No. ROBAR remains a supported product and Innovatum still sells it to customers who want it. RONOVA is the newer platform and is where most new deployments go, but moving is a decision you make on the merits rather than a deadline you are handed. If you need the support position for your own deployment in writing, ask Innovatum for it directly rather than planning around a date on a web page.
- Do we lose our label templates and history?#
- No. The supported path carries across label templates, master data and approval history, and Innovatum handles the migration and revalidation rather than leaving an existing configuration to be rebuilt. Worth confirming for your own case: whether the migrated history satisfies your record-retention obligation on its own, or whether you also keep ROBAR available read-only for a period.
- Do we have to revalidate?#
- There is revalidation work in any move between systems, and Innovatum handles it as part of the supported ROBAR path rather than leaving it with you, alongside the IQ/OQ/PQ documentation and validation support that comes with RONOVA generally. Ask what that division of labour looks like for your deployment, which documents Innovatum produces and which activities your quality team still executes.
- Can we migrate one site at a time?#
- A phased rollout is the normal shape for multi-site deployments, so that a plant moves when its own validation window allows rather than all sites at once. Confirm the specifics for your estate with Innovatum, including what happens to sites still running ROBAR during the transition.
- Can RONOVA import templates from our current labeling system?#
- RONOVA is built for data migration from existing label systems. What migrates cleanly and what has to be rebuilt depends on what you are moving from and how consistent your current library is, so ask for an assessment against a sample of your real templates rather than a general assurance.
- How does RONOVA compare to other enterprise labeling systems?#
- This site does not publish feature comparisons against named products, because an accurate one requires sourced and dated information about someone else's roadmap and an inaccurate one is worse than none. What is published is RONOVA's own position in detail, including the pricing, which most vendors in this category do not publish at all: that is a comparison you can make yourself.
- What happens to the audit history in our old system?#
- That depends on your record-retention obligations and on what the old system allows, and it is worth settling early because it can outlast the migration itself. The two usual answers are migrating the history or keeping the previous system available in a read-only state; both have a cost, and a migration plan that does not mention it is incomplete.
- Will a demo use our labels?#
- No. Demos run on generic data and generic labels rather than your artwork or your data. What we will do is talk through how the system would work for your particular workflow and requirements, which is a more useful conversation than watching your own label appear on someone else's screen.
The company
Who Innovatum is, how long it has been doing this, and how it relates to RONOVA. About
- Can we speak to an existing customer?#
- Yes. Every Innovatum customer has agreed to act as a reference, so this is a question of matching you to the closest situation rather than of finding someone willing. Ask for a reference running at your scale, in your industry, and ideally mid-way through a rollout rather than years past one: that is the conversation that tells you something.
- How long has Innovatum been doing this?#
- Since 1993, and on regulated labeling specifically for that entire time rather than arriving from print, packaging or general document management. The company is based in Sugar Hill, Georgia.
- What is the difference between Innovatum and RONOVA?#
- Innovatum is the company. RONOVA and ROBAR are both its products and both are supported: RONOVA is the browser-based platform most new deployments go to, and ROBAR is the established enterprise labeling system that can be deployed on premises. ROBAR customers who choose to move to RONOVA do so on a supported path that carries templates, master data and approval history across.
- Is Innovatum big enough to support a global rollout?#
- It is a fair question to ask directly rather than infer, and worth asking in the first conversation. What is on this site: RONOVA runs at single-site manufacturers and across global networks including contract manufacturers, Innovatum's quality system is certified to ISO 9001:2015, and the pricing for an enterprise deployment is published. What is not published is headcount, so ask for it.
Services and support
What Innovatum does alongside the software. Services
- Does Innovatum migrate our existing label templates?#
- Yes: data migration from an existing label system is part of how RONOVA is deployed. What is involved depends entirely on what you are moving from and how consistent your current library is, so the useful version of this answer comes from walking through your actual templates rather than from a general claim.
- Is implementation included in the subscription price?#
- Ask Innovatum directly. The published tier figures on the pricing page are the annual subscription, and how implementation and services are priced alongside them is not stated on this site, which means you should get it in writing rather than assume either way.
- Do we have to change our printing process to use RONOVA?#
- No, that is the intent of configurable printing workflows: they are configured to match the production printing process you already run. This is worth testing hard during evaluation with your most awkward line, because it is the claim that most affects whether a labeling system gets adopted or worked around.
- What support is available after go-live?#
- Support is included in the subscription. Ask Innovatum for the specifics that apply to RONOVA, hours of cover, how to reach support, who answers, and the response and resolution commitment as it is written into the agreement. Get it in the contract rather than in an email: a support commitment you cannot point at is a description rather than an obligation.
- Is Innovatum ISO 9001 certified?#
- Yes. Innovatum holds ISO 9001:2015 certification scoped, as printed on the certificate, to its quality management system for software development, delivery and support. It was issued by National Quality Assurance, U.S.A. (NQA) under ANAB accreditation, is certificate K 17405, and runs to 8 March 2027. The certificate is published on this page, so it can go into your supplier file without being requested. Innovatum is also a member of RAPS and of AIM Global, which are memberships rather than certifications.
- Does ISO 9001 mean RONOVA is validated?#
- No, and the distinction matters in a regulated environment. ISO 9001:2015 certifies how Innovatum operates as a company. Validation is evidence that RONOVA does what it is specified to do in your process and configuration, which is what IQ/OQ/PQ documentation and your own validation activity establish.
- Does Innovatum hold ISO 27001 or SOC 2?#
- Neither is claimed on this site. ISO 9001:2015 is the certification Innovatum has published, and if a specific security framework is a requirement for your organisation, raise it in the first conversation rather than late in a security review: the answer should come from Innovatum in writing.
- Can we see the certificate?#
- Yes, it is published on this page as a PDF, so nothing has to be requested. It carries the certifying body, the certificate number, the scope as printed and the validity dates, which are the four things your own auditors will look for. A certification claim without those is not something an auditor accepts, so it is reasonable to expect all four from any supplier before evaluating further.
By industry
The questions that are specific to a sector's rulebook. Solutions
- Does this cover both medical devices and pharmaceuticals?#
- Yes. Device labeling centres on UDI, symbols and instructions for use; pharmaceutical labeling carries heavier market-specific content and serialisation obligations under the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act. Both require validated change control, and both are served by the same control model.
- We are a contract manufacturer labeling on behalf of others. Does that change anything?#
- The regulatory content belongs to the legal manufacturer, but the printing and the records happen at your site, so the audit trail has to be attributable across both organisations. Destination-driven content and per-customer configuration matter more here than in a single-brand operation.
- Can the label be driven from our formulation data?#
- That is the aim. Ingredient order, allergen declaration and nutrition values all derive from the formulation, so holding them as one record and resolving the label from it removes the reconciliation step where drift happens. Where the formulation lives authoritatively in another system, it flows in rather than being re-entered.
- How are retailer-specific and private label variants handled?#
- As destination-driven content on one controlled template rather than as separate labels per customer. The approval chain can differ per brand while the underlying product record stays single.
- Can one template really serve several OEM formats?#
- The formats differ too much for one layout, but they draw on the same shipment and part data. The practical approach is one controlled product and shipment record, with per-customer label definitions resolved at print time, so adding an OEM is configuration rather than a new parallel process.
- Does this integrate with our MES?#
- Product, order and shipment data flows in from ERP, MES or PLM through documented interfaces rather than being re-entered. Labeling is not the system of record; it consumes the record and produces controlled output.
- Can the label and the safety data sheet be driven from one classification?#
- That is the point of holding the classification as one controlled record. Hazard statements, pictograms and precautionary text resolve from it for both the label and the SDS, so a reclassification reaches both from a single controlled change rather than two edits someone has to remember to keep in step.
- How are agrochemical registration labels handled?#
- Plant protection products carry authorised label text that is approved as part of registration and varies by country. That approved content is held per market on the product record, in the same way other market-specific content is, so the printed label reflects what was authorised in the market of sale.
By company size
Single site, several sites, or a global network.
- 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.
- What does RONOVA cost for a single site?#
- A base deployment starts at approximately $40,000 a year as an annual SaaS subscription, covering one manufacturing site with a core set of users and printers and the full control model: change management, audit trail and electronic signature. The final figure depends on configuration, and the published pricing page sets out what moves it.
- Do we get less compliance capability on a smaller deployment?#
- No. The control model is the product, not a tier of it: change management with reason capture, full audit history and electronic signature for 21 CFR Part 11 are present in a single-site deployment. What scales with the tier is size (sites, users, printers and markets) not governance.
- What happens when we add a second site?#
- It extends the deployment you already have rather than replacing it. Sites, users, printers and markets are configuration, so the system's shape does not change as you grow and there is no second implementation and revalidation to pay for.
- Can we migrate our existing label templates?#
- Yes: data migration from existing label systems and template libraries is part of how RONOVA is deployed. What is involved depends on what you are moving from, so it is worth walking through your current templates in a working session rather than estimating it cold.
- Can each site keep its own printing process?#
- Yes, and that is the point of separating the two. The label record is shared and single; the printing workflow is configured per site to match that plant's printers, lines and sequence. Consistency of the label does not require uniformity of the production process.
- What happens to a label change across sites?#
- It happens once. Because sites print from one record rather than from local copies, there is no distribution and confirmation step: the change is made with its reason captured and every altered object linked, and every site is printing from the changed record from that point.
- Do sites need software installed?#
- No. RONOVA printing is browser-based, so bringing a site on is a matter of users, permissions and printers rather than a local installation to deploy, maintain and validate at every plant.
- How many sites can run under one configuration?#
- Multiple sites under one configuration is the mid-tier shape, at approximately $150,000 a year, and a global network including contract manufacturers is the enterprise shape. Where a given estate lands depends on sites, users, printers and markets together rather than on site count alone, so it is worth pricing against your actual estate.
Capabilities
Questions about specific parts of the system. The platform
- 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.
- Does this replace our ERP or PLM system?#
- No. It holds the regulatory and labeling view of the product and takes authoritative values from ERP or PLM where those already exist. The aim is one source per attribute, not a second system competing with the first.
- How are attributes that differ by market handled?#
- As explicit per-market variants on the same product record. That keeps one product record while allowing an identifier, a classification or a storage statement to carry different values in different jurisdictions.
- What if a market's requirements change?#
- Market requirements are configured centrally and referenced by templates, so the change is made once and applies wherever that market is in scope: rather than requiring every affected label to be found and edited individually.
- Can a single shipment carry more than one market's content?#
- Yes. Where a product ships into a region with several language or identifier obligations, the applicable sets are combined according to the configured rules for that destination.
- How is serial number uniqueness maintained across multiple sites?#
- By allocating distinct ranges to each site or line rather than issuing every number from a single live service. Sites cannot collide because their ranges do not overlap, and a network interruption does not stop a line.
- What happens when a code fails verification?#
- It is handled as a controlled exception: the number is recorded as rejected rather than silently reused or discarded. Batch reconciliation then accounts for every number issued, which is what makes the shipped set defensible.
- Can an eIFU fully replace the paper leaflet?#
- Only for the device categories and conditions set out in EU Regulation 2021/2226, and a paper copy must still be supplied on request within the stated period. It is a conditional permission, not a general substitution.
- How long must previous eIFU versions stay published?#
- For as long as devices using them remain in use, which in practice means well beyond the current revision. That is the reason version identity has to be designed in rather than added later.
- How far back does traceability need to reach?#
- To the product's regulatory retention period, which for implantable devices can run to decades after manufacture. This is why retention and queryability have to be a design decision rather than an operational hope.
- Does traceability depend on serialization?#
- Unit-level traceability does, because it needs a unique identifier per unit. Lot-level traceability does not, and is sufficient for many device classes. The right level follows from the product and its regulatory requirements.
- What is involved in validating the system?#
- Innovatum supplies IQ/OQ/PQ documentation and validation support, and Innovatum's own quality system is certified to ISO 9001:2015. Validation is for intended use, so the qualification is completed against the customer's actual configuration and environment.
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