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Electronic Device History Records (eDHR)Tulip

Streamline compliance processes and ensure your device history records are documented correctly the first time. Leverage powerful apps that can error-proof workflows, track materials, and automate data collection for continuous production visibility.

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Product details

Overview

Tulip Device History Records is a digital solution designed to help manufacturers and regulated industries capture, track, and analyze detailed device production and compliance data. The platform replaces traditional paper-based records with a centralized, digital system that ensures accuracy, traceability, and adherence to regulatory standards. It streamlines the creation and management of device history records (DHR), enabling faster audits, real-time visibility, and improved quality assurance. By integrating with shop floor systems and providing role-based access, Tulip empowers frontline teams to document each step of the production process efficiently, ensuring product safety and compliance.

Features and Capabilities

  • **Centralized digital repository: **All Device History Records (DHR) are stored in a single digital system, eliminating errors from manual paper records and ensuring data consistency, completeness, and easy accessibility.
  • **Step-by-step data capture: **Data is collected at each stage of production via guided, structured input forms tailored to manufacturing and regulatory processes to ensure no critical information is missed.
  • **Real-time visibility for quality teams: **Quality and production teams gain instant access to current production and compliance data, enabling faster decisions and preventing delays.
  • **Automated alerts and notifications: **The system automatically generates alerts for deviations, missing entries, or issues, allowing prompt corrective actions before defective products are made.
  • **Integration with ERP, MES, and shop floor systems: **Seamless integration with existing Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), and shop floor tools ensures continuous data flow and eliminates duplicate manual work.
  • **Role-based access control: **User permissions are finely managed based on roles to secure sensitive data and allow only authorized personnel to input or review records.
  • **Audit-ready reports and dashboards: **Automatically generated reports and visual dashboards simplify regulatory audits and internal quality checks by providing clear, accessible compliance data.
  • **Detailed process parameters and operator verification: **Captures precise process details like machine settings, environmental conditions, operator signatures, and timestamps for full traceability and accountability.
  • **Mobile and tablet-friendly interfaces: **Intuitive mobile interfaces enable frontline workers to document data directly at the production site via tablets or smartphones, increasing accuracy and efficiency.
  • **Advanced analytics tools: **Built-in analytics help identify patterns and inefficiencies to drive continuous quality and productivity improvements.
  • **Scalable for regulated manufacturing: **The platform supports diverse manufacturing environments, especially those requiring strict regulatory compliance such as medical device production.
  • **Secure cloud-based storage: **Data is securely stored in the cloud, ensuring integrity, availability, and easy, location-independent access.