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Discover Solutions for Compliance with GTH & Eurotherm’s 6100A /6180A Paperless Graphic Recorder

As industries evolve and regulatory standards tighten, the demand for compliant and efficient data acquisition solutions has never been greater. Recent updates from regulatory bodies such as the Food & Drug Administration (FDA) with 21 CFR Part 11, the Society of Automotive Engineers (SAE) with AMS2750G, Automative Industry Action Group (AIAG) with CQI-9 have directly affected electronic data collection. While these specific regulations don’t always dictate whether records should be kept electronically or on paper, many industrial operators in aerospace, pharma, and food & beverage have already made the transition to electronic record-keeping systems due to efficiency, ease of access, and potential for greater data integrity. If you haven’t made the transition to electronic record -keeping, it might be time to consider that path.

In a previous blog titled, “Navigating the Digital Frontier of Industrial Operations: the Path to Paperless Record-Keeping”, you’ll find a comprehensive overview of benefits to make the transition from paper to electronic data acquisition for your organization.

In this blog, we’ll delve into these regulations and explore how Eurotherm® 6100A / 6180A Paperless Graphic Recorder series offers a seamless path to compliance and operational excellence. Let's start by understanding the regulatory landscape and then we’ll discuss this specific recorder.

FDA 21 CFR Part 11 sets forth stringent requirements for electronic recordkeeping systems, ensuring the integrity, reliability, and security of electronic records and signatures. Compliance with Part 11 is mandatory for industries such as Bio-Pharmaceutical and Food and Beverage, necessitating the secure capture and storage of all electronic records and signatures related to product manufacturing. Key provisions include data protection, accuracy, efficient retrieval, and the implementation of secured, time-stamped audit trails. While no specific deadline exists for transitioning to paperless record-keeping, businesses must ensure compliance when adopting electronic systems, involving system validation and security measures implementation.

AMS2750G and CQI-9 covers pyrometric requirements for equipment used in thermal processing of metallic materials used across industries like aerospace, automotive, and manufacturing. The standards ensure the accuracy and reliability of temperature measurement and control systems, specifically for temperature sensors, instrumentation, thermal processing equipment, correction factors and instrument offsets, system accuracy tests, and temperature uniformity surveys. These are necessary to ensure that parts or raw materials are heat treated in accordance with the applicable specifications. Transitioning from paper to electronic data acquisition is recommended to enhance efficiency and accuracy in thermal processing operations.

At George T. Hall (GTH), we are proud to be Authorized Solutions Partners with Eurotherm and Watlow. Following Eurotherm's recent acquisition by Watlow, they are now strongly positioned to serve key industries such as Heat Treat, Pharmaceutical, and Food & Beverage. Their products meet all relevant requirements for 21 CFR Part 11 validation and AMS 2750G compliance. Eurotherm and Watlow are leading providers in temperature, power, and process control, as well as measurement and data management equipment, systems, and software across various industrial applications. This alignment with GTH underscores our shared history and expertise, solidifying our position as trusted system integrators and engineers within thermal processing.

Eurotherm® 6100A / 6180A Paperless Graphic Recorder

Eurotherm describes this series of data recorders being specifically designed to meet industry requirements for data integrity of process records in pharmaceutical, aerospace, automative and food & beverage applications. We recently obtained a demo of this recorder for our engineers to test and practice the configuration and programming. Through our testing we found that Eurotherm 6100A / 6180A paperless graphic recorder and the Data Reviewer software to be superior to that of its competitors.

We found these recorders deliver exceptional performance and reliability, boasting a capacity extendable to 48 precision input channels and recording intervals as low as 125ms. Key features of these recorders include secure data recording, full-color touch screen displays, batch functionality, remote viewing and configuration, and USB "Plug & Play" support. Enhanced cybersecurity measures ensure data integrity, with features such as data encryption and redundancy to prevent loss in network connection failures. The 6180A Series stands out for its input accuracy and configurability, offering intuitive touch screen displays for clear process data visualization. Onboard Flash data storage, Ethernet communication capabilities, and a choice of storage media ensure secure, long-term data storage compliant with regulatory standards.

While we won’t delve into the features and benefits within this specific blog, it’s worth noting that Eurotherm provides a TUS (Thermal Uniformity Survey) Recorder designed to meet the rigorous standards of AMS2750G. With instant-on accuracy, an overall maximum error of +/-0.5ºF, and high stability to minimize drift, this device stands as a best-in-class solution for the Heat-Treating Industry. Stay tuned for our upcoming blog where we’ll explore Thermal Uniformity Surveys and discuss this recorder in detail. In the meantime, for a description and specifications of this recorder, click here.

Eurotherm® Data Reviewer

Complementing the 6100 series recorders, Eurotherm Data Reviewer provides powerful software for viewing, analyzing, and printing the 6000 series “UHHH” files (encrypted historical data). Features like browser-based installation, dual cursor mode for data analysis, and support for multiple data viewing styles enhance usability and efficiency, making it an invaluable tool for users seeking comprehensive data management solutions.

After testing out the software, our engineering team stated the functionality, ease of use, advanced visualization capabilities, viewing of batch information, and adherence to regulatory standards are all reasons why the Data Reviewer software would be a leading recommendation for our customers. They noted a few specific features that support that statement.

1. The software's capacity to visualize and monitor multiple data points concurrently over time is particularly advantageous for heat treat facilities. This functionality facilitates tracking temperature variations, enabling users to meet specific process requirements more efficiently.
2. The batch functionality allows users to distinguish and categorize data according to specific batches. This feature streamlines data management processes, simplifying the identification and analysis of relevant information without the need for manual sorting.
3. Compliance with regulatory standards AMS2750G, CQI-9, and 21 CFR Part 11 assures users that their data management practices align with industry requirements and quality standards. This aspect offers peace of mind and minimizes the risk of non-compliance issues.

By discussing with your team GTH can tailor your recorder requirements, provide configuration of the recorder, and provide ongoing local support as well as calibration service. As a full-service control solutions provider, GTH has nearly a century of experience in thermal processes. You can trust in our ability to support past, current, and future technologies. Our team and our solutions are built beyond expectations. Leveraging our legacy of expertise in this field alongside Eurotherm’s premier products ensures seamless system upgrades and replacement part sourcing.

For a more in depth description of this recorders features and specifications, click here to review, or click here to contact GTH for a quote.

For more information on the FDA 21 CFR Part 11 requirements & the Eurotherm 6000 series graphic recorder, click here.

For more information on the AMS2750G pyrometry solutions& the Eurotherm 6000 series graphic recorder, click here.

A recent blog written by Watlow on regulatory compliance and evolving industry standards for AMS2750G can be found by clicking here.