Data Acquisition & Reports
Today’s manufacturers and service providers must operate within a significant regulatory environment imposed by a myriad of agencies such as FDA, NADCAP, EPA, OSHA, and DEP, to name only a few. Meeting their wide-ranging and complex compliance and reporting requirements can be a daunting challenge that demands solid data acquisition, storage, processing, and visualization that is accurate, reliable, secure, and readily accessed and managed. To help you instead focus on your core business, Neal Systems offers cutting edge data acquisition and reporting solutions to meet your particular need.
Click below to see our Data Acquisition & Reports solutions for your application need:
- Recorders & Data Acquisition Units
- Analytics Solutions
- Compliance & Reporting Capabilities
Recorders & Data Acquisition Units
Where process data needs to be logged over an extended period of time, a data recorder can be used, providing secure data storage and easy access to process records. Eurotherm Chessell produce a wide range of products to meet any data recording, archiving, and management need with the highest level of electronic file protection. Powerful hardware and software options can be tailored to the application requirement, enabling the user to configure online and off, remotely view real time data, and create historical charts and application specific reports.
AnalytiX from Iconics is a suite of products that transforms large amounts of real-time data from manufacturing and facility operations to drive improvement in productivity, efficiency, quality, and sustainability. The suite includes rich, dynamic visualization tools and a wide variety of analysis functions.
Facility AnalytiX is a predictive equipment diagnostic solution to analyze all available information to detect and predict faults in equipment, applying algorithms to prevent equipment failures or excessive use of energy.
The Iconics Historian family of products ensures data is never more than a few clicks away. The powerful Iconics platform offers universal connectivity through open standards and widely accepted communication protocols for acquiring and analyzing all data necessary to make informed decisions in real time. Hyper Historian is a plant process historian designed to log data at greater than 100,000 tags per second and works with multiple data sources across the enterprise providing full, web-based configuration via its integrated engineering Workbench.
TrendWorX64 is a plant-wide data collection, logging, charting, reporting, and analysis solution, offering tools to trend and chart real-time and historical data from any relational database.
Compliance & Reporting Capabilities
Neal Systems’ product line meets a broad range of customer requirements for regulatory compliance and reporting. Click on the links below to see how our data acquisition and report products can meet your need.
To learn the differences, watch the video on this page.
Standards such as the AMS 2750 E (Aerospace Material Specifications) are applicable for the industrial processing of high-quality materials. They define industry-specific requirements for heat treatment. Today, the AMS 2750E and derivative standards such as AMS 2770 for the heat treatment of aluminum are the guidelines for the aerospace industry. After the introduction of the CQI-9, the automotive industry has also committed to submit heat treatment processes to stricter rules. These standards describe in detail the requirements applicable to thermal processing plants, such as:
- Temperature uniformity in the charge space (TUS)
- Instrumentation (definition of measurement and control systems)
- Calibration of the measurement system (IT) from the controller via the measurement line to the thermocouple.
- Inspections of system accuracy (SAT)
- Documentation of the inspection cycles
Norm compliance is necessary to ensure that the required quality standard of the manufactured components can also be reproduced in series. For this reason, extensive and repeated inspections as well as controls of the instrumentation, including the relevant documentation, are required.
Depending on the quality requirements of the heat treatment job, the customer specifies instrumentation type and the temperature uniformity class. The instrumentation type describes the necessary combination of the applied control, recording media as well as thermocouples. The temperature uniformity of the furnace and the class of the selected instrumentation are defined based on the required furnace class. The higher the requirements are set for the furnace class the more precise the instrumentation must be.
The furnace or the heat treatment system must be designed so that the requirements of the AMS 2750 E can be met and be reproduced. The standard also requires the inspection intervals for the instrumentation (SAT = System Accuracy Test) and the temperature uniformity of the furnace (TUS = Temperature Uniformity Survey). The SAT/TUS tests must be performed by the customer with measuring devices and sensors which operate independently of the furnace instrumentation.
The Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails and any corresponding requirement. Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date, time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries. Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records. We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. We suggest that you apply appropriate controls based on such an assessment. Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation.
The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records and any corresponding requirement. You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)). The FDA recommends that you supply copies of electronic records by:
- Producing copies of records held in common portable formats when records are maintained in these formats
- Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML).
In each case, the FDA recommends that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.
The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period and any corresponding requirement. Persons must still comply with all applicable predicate rule requirements for record retention and availability (e.g., §§ 211.180(c),(d), 108.25(g), and 108.35(h)).
The FDA suggests that your decision on how to maintain records be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment and a determination of the value of the records over time.
FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML). Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. In addition, paper and electronic record and signature components can co-exist (i.e., a hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved.