Eurotherm solutions can help reduce the time and cost of regulatory compliance and strengthen trust throughout manufacturing processes and supply chains.
In life science manufacturing, process data is as important as the medicine being produced. Failure to comply with internationally recognized regulations such as FDA 21 CFR Part 11 can be detrimental, not only in terms of inadequate insights. Serious failures with Data Integrity can lead to audit warning letters, product scrutiny and even manufacturing suspension. They can damage a reputation and lose public trust. Good data practices enrich the quality of data, enabling life sciences leaders across operations, production and quality to make informed, strategic decisions on batch release, based on trustable data and analytical insights.
With specialist knowledge and experience, Eurotherm™ by Schneider Electric delivers life sciences solutions that help manage the quality, the safety and the authenticity of manufactured goods. “Our expertise in machine and process automation efficiency and high integrity data management, including qualification and validation services to ISPE GAMP® 5 guidelines, enable us to help customers optimize their solutions,” said Sébastien Girard, Eurotherm Global Business Development Manager for Consumer Packaged Goods (Life Science/Food & Beverage).
Eurotherm provide solutions to help maintain Data Integrity throughout the data lifecycle. Products are aligned with the latest global best practices such as cGMP, FDA 21 CFR Part 11, EMA Annex 11 and Data Integrity ALCOA (+) principles. Enhanced regulatory requirements demand that GxP critical records comply with the ALCOA (+) concept to maintain Data Integrity and quality.
Eurotherm has recently released Data Reviewer software that now includes an Auditor option designed to aid Data Integrity and help simplify audit compliance. Eurotherm 6000 Series Recorders, nanodac™ Recorder/Controller, T2750 PAC and versadac™ Scalable Data Recorders together with Data Reviewer are designed with password-controlled user access and electronic signatures. These provide event traceability within digital tamper-resistant audit trails for quality approvals aiding compliance to regulations.
Eurotherm solutions are chosen for the control and monitoring of labs, storage environments and process manufacturing because of their proven reliability and input accuracy (0.1% of reading with correct field calibration) and proprietary tamper-resistant data recording file format. EcoStruxure™ Manufacturing Compliance Advisor, a Eurotherm-designed, cloud-hosted digital platform with asset compliance at the core of the solution will also be launching a significant enhancement this month. Developed to help minimize testing costs, increase productivity and ease the asset audit process, the solution is extended, connecting organizations to further optimize asset testing and compliance requirements.
Eurotherm solutions are EcoStruxure-ready, providing a Data Integrity layer within the Schneider Electric EcoStruxure platform. EcoStruxure is Schneider’s open IoT-enabled system architecture aiding the digital transformation to Pharma 4.0 technology. Discover how to get more from your life sciences manufacturing operations Data Integrity Solutions.