New Data Logging Capabilities to Support Quality Processes

Tommy Nielsen ApS is excited to announce the launch of Enhanced Data Logging Capabilities across our Universal machines, transforming production data into a powerful, automated tool for Quality Management, compliance, and accelerated project validation.

This new system is seen as a quantum leap, specifically tailored to help low to medium volume blister packaging operations meet stringent quality and regulatory demands.

Key Advantages of the new Data Logging System

Ensures Consistent Quality at Low Volumes: Automated data capture limits process variability that can be challenging to control in low volume, high-mix production environments. By synchronizing tooling and product parameters, this feature guarantees uniform, high-quality blister packaging outcomes from the very first batch onward, significantly reducing the risk of quality deviations and rework.

Achieve Full Traceability: Every packaging step is recorded with time-stamped details, including operator credentials, batch numbers, and set-up parameters. This full, verifiable audit trail is essential for Corrective and Preventive Actions (CAPA), allowing you to quickly detect, document, and resolve quality issues—a critical need for all regulated projects, regardless of batch size.

Simplifies Compliance with ISO 13485: Built-in data logging provides transparent and easily exportable records of equipment, process, and product settings. This feature helps your team demonstrate immediate alignment with regulatory expectations and standards like ISO 13485:2016 without the burden of manual record-keeping.

Accelerates Project Validation: The verifiable process data serves as ready-made input for IQ, OQ, PQ processes. By automatically gathering this required documentation, we can significantly shorten validation timelines for new projects and streamline technology transfer, getting your specialized products to market faster.

This enhancement confirms our commitment to providing sophisticated, compliance-focused solutions that empower our partners’ low-volume packaging. It underscores our desire to provide our partners with the tools necessary to achieve and maintain the highest levels of quality and efficiency within medical packaging.

Exhibitor Data Sheet