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Upgrade for FDA compliant paperless recorders

Edited by the Engineeringtalk editorial team Aug 8, 2005

The DXP family of paperless recorders are specifically designed to meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11.

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 US 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.