Platform
Validation that does not restart every quarter.
In a regulated environment the question is never whether a system works. It is whether you can prove it works, and whether that proof survives the next release.
The shape of a validation.
The standard three qualifications, in the order they run. What differs between vendors is not the names but how much of the evidence you have to produce yourself.
Installation qualification.
Evidence that the system is installed and configured as specified, in the environment it will run in. For a SaaS deployment this covers the environment and configuration rather than a local install.
Operational qualification.
Evidence that each function behaves as specified across its operating range, including the controls that carry your compliance case: audit trail, signature, permissions, change control.
Performance qualification.
Evidence that the system performs as intended in your process, with your labels, your printers and your people. This is the qualification that cannot be delivered generically, because it is about your workflow.
What keeps it proportionate.
Risk-based, not uniform.
GAMP 5's premise is that testing depth should follow the risk of the function. Applied honestly it means the signature path and the audit trail get rigour, and a colour picker does not.
Change control defines the scope.
Because every change carries its reason and links every object it alters, the question "what does this change affect" has an answer in the system. Revalidation scope follows that answer instead of defaulting to everything.
Configuration is where your risk lives.
Two companies running the same product have different validation exposure because they configured different workflows. Validation is executed against your configuration for that reason.
One system, not one per site.
Browser-based printing means there is no local installation at each plant to qualify separately, which is where multi-site validation effort usually multiplies.
Questions people ask.
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.
Do we have to revalidate RONOVA after every software update?
Not from scratch. Under a GAMP 5 risk-based approach, the scope of revalidation follows what a release changes and which of those functions your configuration actually uses, so a release that touches nothing you rely on calls for an impact assessment rather than a repeat of IQ/OQ/PQ. Your own validation procedure sets where that line falls. 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.
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.
Read next.
Traceability
Full genealogy from incoming material to shipped unit, queryable for the product's regulatory retention period.
Architecture
How RONOVA deploys and fits an existing stack: hosted cloud or private cloud, integrated with ERP, MES and PLM.
Label and Artwork Management.
Store assets, design and edit artwork, mark up for review, check compliance and track every version of every label, in one controlled system.
Compliance
The controls and the regulations.
Services
What Innovatum does alongside the software.
Your process, your rules.
Experience web-based production printing workflows tailored entirely to your line mechanics.