Tokyo, Japan - March 8, 2010
Today, Yokogawa Electric Corporation is releasing DXAdvanced® R4, an enhanced version of the DXAdvanced data acquisition and display station for networks that is part of the Daqstation® series of paperless recorders.
With this enhanced version, new functions have been added that are compliant with the 21 CFR Part 11* regulation (hereafter Part 11), a de facto global standard for electronic records and electronic signatures that was defined by the US Food and Drug Administration (FDA). By using these functions on a multi-channel, high-speed paperless recorder with a large memory, pharmaceutical companies can easily record and manage various kinds of data from the manufacturing process.
DXAdvanced® R4
Development Background
There are two types of industrial recorders: the conventional type, which prints measurement data on recording paper, and the new type, which records this data on electronic media. This second type is rapidly spreading in popularity. The World Health Organization's (WHO) good manufacturing practice (GMP) guidelines require pharmaceutical companies to keep records on items such as sterilization and freeze-drying times in order to prevent contamination during the manufacturing process. Although the GMP guidelines require paper records, records stored on digital media have the advantage of taking up far less space and also can be searched and accessed much more readily. The FDA therefore established the Part 11 regulation to address topics such as tampering prevention and providing electronic approval for the digitization of records, and has approved the keeping of electronic records on the pharmaceutical .manufacturing process by pharmaceutical companies. In 2001 Yokogawa released the Part 11-compliant DX100P and DX200P.DX paperless recorders. Since then, Part 11-compliant recording has become the de facto standard worldwide in the drug manufacturing industry and demand for Part 11-compliant paperless recorders is on the rise.
In addition to having these Part 11-compliant functions, the DXAdvanced R4 has all the advanced functions provided in our high-end DXAdvanced R3 model, namely, the support of multiple channels, a large memory, and high speed recording.
Product Features
Like all models in the DXAdvanced series, DXAdvanced R4 is a paperless recording device, and its use of electronic storage media not only saves space but also facilitates data searching and access. Other shared features include the ability to remotely record data over a network, support of many channels (up to 48), a large memory, and high-speed measurement. In addition, it has the part 11-compliant functions described below.
- Part 11-compliant functions
Yokogawa uses a proprietary binary data storage format that provides a very high degree of protection against data tampering. In addition, the DXAdvanced R4 has a login function that restricts device access to authorized individuals who electronically sign in either at the DXAdvanced R4 or from a PC. Finally, there is a function that keeps an audit trail by storing a log on all operations performed with the main unit.
Major Target Markets
A wide range of manufacturing and process industries including electric power, petrochemicals, chemicals, iron and steel, nonferrous metal, pulp and paper, foods, pharmaceuticals, electrical equipment, ceramics, automobiles, and water and wastewater
Applications
The recording and monitoring of various kinds of manufacturing process data such as temperature, pressure, flow rate, and chemical composition
* Title 21 CFR Part 11 of the Code of Federal Regulations
Regulations defining the requirements for digitizing and maintaining manufacturing records and documents that must be submitted for drug approval in the US
About Yokogawa
Yokogawa's global network of 19 manufacturing facilities and 85 companies spans 40 countries. Since its founding in 1915, the US$4 billion company has been engaged in cutting-edge research and innovation, securing more than 8,000 patents and registrations, including the world's first digital sensors for flow and pressure measurement. Industrial automation and control, test and measurement, information systems and industry support are the core businesses of Yokogawa. For more information about Yokogawa, please visit our web site at www.yokogawa.com