LABELai is a patent-pending tool that enables companies achieves their End-to-End regulatory labeling goals. With option of using the system for either Label Lifecycle Management (LLM) or Label Operations or both, companies can pick the part of the tool that enhances their productivity and efficiency.
Content part ensures top-down approach linking content and operations seamlessly. LABELai utilizes Artificial Intelligence and NLP business rules internally coupled with local country requirements (Reg Intel built-in) and all of this delivered in a cloud platform to reduce IT burden drastically. In turn, all label aspects managed automatically without manual efforts. With the use of an automated tool, labeling teams can reduce time, costs and non compliance challenges.
End to End (E2E) Label Operations
Manage labeling operations from content to local operations to supply chain
Workflow based with “no programming” involved for agility
Metrics management and detailed reports/dashboards for different stake holders
“Light processes” for non-core labeling teams like local RA, artwork or supply release teams
Built-in project and program management
Label Lifecycle Management (LLM) & Automation
Provides end to end labeling such as CCDS create/update, SmPC/USPI create/update, and LPDs
Company Core Data Sheet (CCDS) – creation and updating. Maintain Core package automatically
Automating local label creation from any of CCDS or as most companies prefer instead use SPC / USPI as source documents.
Reg Intel built-in for 50+ countries (and you can bring in your custom country requirements as well)
Structured Product Label (SPL) creation and updating
Full Local labels Life cycle management including translation processes
Label tracking, safety compliance and version history reports
100% Label QC automation
Global Labeling Compliance
Compliance Automation for local label deviations and local deviation safety compliance
Set rules/controls for alerts on deviations
One-click reports to get any deviation on any product in any country
Access to 60k+ approved marketed products labels from Canada, USA, EU
Compare different versions and 3rd party labels section-wise, side-by-side