Schneider Electric Launches Enhanced Life Sciences Solutions that Further Strengthen Data Integrity

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ASHBURN, Va. - eTradeWire -- Schneider Electric releases enhanced products, solutions and engineering services for the life sciences industry to help reduce the time and cost of regulatory compliance and strengthen trust throughout manufacturing processes and supply chains.

Lack of Data Integrity can lead to the loss of public trust

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.

Eurotherm solutions are designed to reduce time and cost of regulatory compliance

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).

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Trusted advisor to the life sciences industry

• Eurotherm Data Reviewer aids Data Integrity and helps simplify audit compliance
• Enhanced Recorders and Temperature Controllers help meet ALCOA (+) principles with password-controlled user access and electronic signatures • EcoStruxure™ Manufacturing

Compliance Advisor platform helps manage asset compliance

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.


Hashtags: #lifesciences #dataintegrity #21CFRPart11 #ALCOA #GAMP #GxP #LifeIsOn

Source: Eurotherm by Schneider Electric
Filed Under: Biotech

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