Labeling Automation, Content Lifecycle & E2E Platform
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
Labeling Strategy
- Access to 60k+ approved marketed products labels from Canada, USA, EU
- Compare different versions and 3rd party labels section-wise, side-by-side
- Labeling regulatory intelligence (country requirements) built-in
Key Benefits:
- All teams full empowered reducing too many dependencies and manual handoffs
- Built-in Change control & implementation full cycle
- Leverage built-in automation to gain efficiency
- Reduce process and content errors at every stage (literally, no QC needed for local labels)
- Maintain absolute compliance
- Inbuilt global labeling regulatory intelligence
- Deep Cost savings
To Know More about DDi’s LABELai, a patent pending Drug & Device Labeling Automation Software, and to take a feature-specific comprehensive product tour.
