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Achieving Data Integrity in the Life Sciences Industry

Data management designed to simplify regulatory compliance and enhance trust

Rapid world growth, globalization, advanced technologies for Pharma 4.0 automation and data analysis trends, are emphasizing the need for high standards of data quality and integrity. Good data practices (GxP) will enrich the quality of data, enabling life science companies to make strategic decisions on batch release, based on trustable data and analytical insights.

The pharmaceutical and biotechnology industries closely regulate data production and storage to make sure that data cannot be modified without detection. Regulatory bodies such as the FDA and EMA, as well as global institutions and associations like the WHO, ISPE, PIC/S and local CDSCO, NMPA, MHRA, ANVISA, etc, emphasize the need for accurate measurement and secure storage of critical process and environmental parameters. If such storage mediums are electronic, then the methods used for controlling and monitoring of data should comply with regulations, for example FDA 21 CFR Part 11, to help ensure data integrity.

To discuss your data integrity needs:

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Lack of data integrity could lead to:

  • Inadequate strategic data insights
  • Audit warning letter
  • Product scrutiny/suspension
  • Import bans, forced recalls, plant shut down/debarment
  • Legal action
  • Loss of reputation/public trust

Our knowledge and expertise covers the following and more:

  • FDA 21 CFR Part 11
  • EMA Annex 11
  • Data Integrity ALCOA (+)
  • ISPE GAMP® 5
  • cGMP

Eurotherm solutions for the life sciences industry

With specialist knowledge and experience in the life sciences industry, Eurotherm™ by Schneider Electric delivers solutions that help businesses to reduce the time and cost of regulatory compliance, throughout their manufacturing processes and supply chains. Our solutions and services help customers to efficiently manage the quality, the safety, and the authenticity of manufactured goods, through machine and process automation efficiency, high integrity data management, and an ISPE GAMP® 5 engineering approach with qualification and validation services.

Data Integrity ALCOA (+) Concept

Enhanced regulatory requirements demand that GxPcritical records comply with the ALCOA (+) concept to maintain data integrity and quality. As a trusted advisor to the industry Eurotherm offers a range of solutions to help maintain data integrity throughout the data lifecycle.

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The Data Lifecycle

Discover the data lifecycle and dataflows within Eurotherm recorders and associated PC tools, from data creation, through data processing, reviewing, reporting and use to data retention retrieval and destruction.

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Data Management, Acquisition and Control Solutions

The Eurotherm portfolio ranges from discrete products and software to engineered systems, embedded with a variety of features that help meet Data Integrity ALCOA (+) principles.

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Store and Forward Feature

Eurotherm Store and Forward feature aids reliability of data archiving, supporting the ALCOA (+) data integrity concept by providing original, attributable data that is contemporaneous, consistent and complete.

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Pharma 4.0 Ready Solutions

Data recording solutions from Eurotherm have Ethernet communications, providing a data integrity layer within, the EcoStruxure™ platform. EcoStruxure is Schneider Electric’s open IoT-enabled system architecture. Digital platforms and services such as EcoStruxure enable pharma and life science companies to increase production while maintaining compliant systems and improving sustainability and efficiency.

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Engineered Solutions for Life Sciences

As well as data management solutions, Eurotherm global projects teams and Authorized Solution Provider network offer a range of control systems and services from simple engineered solutions to plantwide automation and turnkey projects.

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