These recorders have been designed to meet 21 CFR Part 11, which identifies the requirements necessary for the storage of electronically produced data within the pharmaceutical industry
Yokogawa has introduced a number of major enhancements to its DXP family of paperless recorders, which are specifically designed to meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11, covering the storage of electronically produced data in the pharmaceutical industry.
The new DXP Style 5 recorders are equipped for use with SNTP (simple network time protocol), so that a recorder can be linked as a client to an SNTP server on a network.
Alternatively, one recorder can be used as an SNTP master to a number of other recorders on a network.
In each case, the recorders will be automatically synchronised with the network clock, removing the effects of clock drift between different units.
Any time adjustment by the SNTP client is recorded in the operation log, and the records of access from the SNTP client to SNTP server are recorded in the SNTP log.
The SNTP log can be shown on the DXP itself, and it can be output by communication command.
Thus the all-important audit trail is maintained.
Other new recording and display features include a manual save function, which initiates a memory dump into a Zip drive; a first-in/first-out facility for recording on external media; automatic configuration for daylight-saving time; and the ability to configure the time, number of users and calibration during memory start.
It is also possible to carry out calibration correction and user name changes while the unit is actually running, eliminating the need to halt the recording process in the event of an incorrect password being entered, for example.
Authority for the calibration correction configuration can be given to users, and sequential multiple channels can be set at the same time.
Up to 90 users can access the system simultaneously.
Other new features include the ability to change the monitor display format - from digital to trend, for example, without a user being logged in, plus a wide range of communications functions.
The Yokogawa DAQSTATION DXP family of pharmaceutical recorders save data in secure, binary-encrypted files, which include batch information, configuration settings, and the audit trail of the access to the recorder system, including the serial number of the device the data was recorded on.
Log-in functions require user name, user ID and password security, and provide controlled access to all recorder functions including the application of electronic signatures.
Full access to the recording system is provided by the administrator log in, of which there are three.
User access is set up by the administrator, who also determines the rights of each user.
No user or administrator can see anybody else's password, and a password ageing function allows passwords to be periodically changed at the request of the system.
These recorders have been designed to meet the requirements the United States Food and Drug Administration's regulation 21 CFR Part 11, which identifies the requirements necessary for the storage of electronically produced data within the pharmaceutical industry.
Using electronic records provides a solution to the problems encountered by paper based recorders, for example data being lost due to consumables such as pens and paper running out during recording, the difficulty of storing paper after data recording, and data management.
In addition, it simplifies the retrieval of historical records by the ability to search by batch name.
Yokogawa's global network of 18 manufacturing facilities, 82 affiliate companies, and over 650 sales and engineering offices spans 28 countries.
Since its founding in 1915, the US$4 billion company has been engaged in cutting-edge research and innovation, securing more than 7000 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.
The European headquarters were founded in Amersfoort, the Netherlands in 1982.
Throughout Europe Yokogawa has its own sales, service and engineering operations.
This dedicated network has been extended to central and east Europe and southern Africa to further enhance the coverage and support associated with serving the process control and automation market place.
Yokogawa develops and produces flowmeters at Rota Yokogawa in Germany, liquid analysers and industrial safety systems in the Netherlands.
In addition to this dedicated network of Yokogawa subsidiaries a select organisation of test and measurement (T and M) subsidiaries and distributors is established in certain areas to support the specific customer needs of this continuously developing and specific market of T and M instrumentation.
Yokogawa UK is a supplier of technology to the process, manufacturing and utility sectors.
Yokogawa UK's headquarters are in Runcorn, Cheshire, with additional system sales support operations in Milton Keynes.
