Platform
Architecture
Labeling is not a system of record. It consumes product data from wherever that data authoritatively lives and produces controlled output for production, so how it integrates matters as much as what it does.
What it does
Three deployment models
Hosted cloud or private cloud. The choice is usually driven by data residency, validation posture and existing infrastructure policy rather than by cost.
Documented integration interfaces
Product, order and master data flow from SAP, Oracle and other ERP, MES and PLM systems through documented APIs and message-based interfaces rather than manual re-entry.
Validation-ready
IQ/OQ/PQ documentation and validation support are supplied, so the deployment can be qualified rather than validated from scratch by the customer.
Role-based access control
Access follows role, with enforced re-authentication for signing actions, so the approval record is attributable to a person.
Logically isolated per customer.
In the hosted service, every customer runs in its own logically isolated tenant database: separated at the database level rather than filtered in the application layer. A private-cloud deployment is single-tenant by definition.
How it works
Data in from the system of record.
Rather than duplicating ERP or PLM, the system references authoritative values so there is one source per attribute.
Controlled content out to production.
Approved templates and resolved market content are made available to printing at the point of production.
Records retained under control.
Approvals, print events and data changes are retained with attribution and timestamps for the required retention period.
Qualified in place
The deployed instance is qualified in its actual environment, which is what validation for intended use requires.
Regulatory context
What this speaks to.
The regulations and standards this capability is built against. Always check the current text of any regulation before relying on it.
- 21 CFR Part 11: access control, audit trail, electronic signatures
- EU Annex 11: computerised systems in regulated environments
- GAMP 5: risk-based validation approach
- ISO 9001:2015: Innovatum's own quality management system, certified
Questions about this capability.
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.
Related capabilities
Label Management
Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.
Regulatory Data
One master record for product and regulatory attributes, so the label, the artwork and the ERP cannot disagree with each other.
Serialization
Unique serial numbers issued, applied and recorded under the same change control as the rest of the label, at production line speed.
Adapt to any factory floor.
See how our web-based printing scales to match your exact production lines.