In regulated sectors, measurement accuracy has a direct influence on compliance with standards such as ISO 13485 in Europe and CFR 21 Part 11 in the USA. Ellistat updates its Quality Suite to automate measurement traceability and meet the regulatory requirements of the medical and pharmaceutical sectors.
Guaranteeing the integrity and traceability of measurement data is a central requirement in medical and pharmaceutical manufacturing, where product conformity and safety depend on reliable quality control processes. In this context, Ellistat has introduced an evolution of its Quality Suite to automate data recording and reinforce long-term traceability.
Measurement data at the heart of regulatory compliance
In regulated sectors, measurement accuracy has a direct influence on compliance with standards such as ISO 13485 in Europe and CFR 21 Part 11 in the USA. These standards require traceable and verifiable data to demonstrate product conformity and process reliability.
Reliable measurement data enables deviations to be detected quickly and corrective action taken, reducing the risk of non-conforming production. With the digitization of industrial environments, real-time data collection improves responsiveness and supports continuous process improvement within the digital supply chain.
Automated data recording without manual intervention
The updated Quality Suite features automatic recording of measurement data, eliminating the need for manual entry. Each measurement is recorded directly in the system, together with contextual information such as serial number, date and operator ID.
This feature applies to IQC (Incoming Quality Control) and SPC (Statistical Process Control) system, which centralizes data from supplier controls, ongoing operations and final validations. By preventing manual modification, the system reduces the risk of data manipulation and improves data reliability.
Integration with measurement equipment
The solution supports equipment capable of generating digital files, facilitating their integration into quality management workflows. For specific systems, such as Zeiss and the Metrios, direct recording in the measurement program, with mandatory data archiving.
This approach ensures that every measurement is automatically recorded and traceable, thus meeting auditing and process transparency requirements.
Long-term traceability and audit readiness
The system enables measurement data to be stored and traced over long periods, up to ten years, in line with the regulatory requirements of the medical and pharmaceutical sectors.
Complete tracking of the data lifecycle facilitates audits by providing rapid access to historical data, and ensuring that operations can be reconstructed if necessary.
Enhancing the safety of quality processes
The solution integrates electronic signatures in the IQC, SPC and APC, This enables actions to be validated securely. All modifications made to the system are recorded, ensuring complete traceability of events.
Sorting, searching and editing functions make it easier to exploit the data collected, and contribute to more efficient management of quality processes.
A solution based on proven methods
The Quality Suite is based on over ten years of development, and draws on methodologies such as statistical process control, experimental design and Six Sigma.
By combining automation, traceability and compliance, the solution enables manufacturers to maintain high quality standards while meeting the growing demands of regulated environments.
