Paperless recorders fit US pharmaceutical specs

Edited by the Engineeringtalk editorial team Mar 15, 2002

A new range of paperless recorders is specifically designed to meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11.

Yokogawa has introduced a range of paperless recorders 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 Daqstation DX100P/DX200P 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.

Up to 30 users can be configured.

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 functions conform directly with all requirements of the 21CFR Part 11 rule, and as such make the DX-P recorders compliant with pharmaceutical regulations.

Yokogawa has also commissioned a White Paper from Stelex, a leading US authority on pharmaceutical validation, which provides a third-party independent test of conformance to 21CFR Part 11 with the DX-P recorder and a validation protocol (IQ/OQ) to reduce the time taken to validate the DX-P as part of a total system.

The US Food and Drug Administration issued Regulation 21 CFR Part 11, now adopted as a standard within the pharmaceutical industry, to overcome the problems of paper-based recording - for example, consumables such as pens and paper running out during recording, and the difficulty of storing and retrieving large quantities of paper-based data.

With the new Yokogawa Daqstation products, electronic signatures can be added to the electronic records by using the recorders' secure log-in and record signing functions.

Alternatively, PC software designed to be used in conjunction with the DX100P/DX200P can apply signatures in the same manner.

Electronic signature information is stored as an attachment to the measurement file in order to protect the original data.

The new recorders use either a 5.5in (DX100P) or a 10.4in (DX200P) high-resolution TFT colour display, and can display data in a wide range of formats including trend, bargraph, digital and overview displays.

The display is easy to manipulate using a simple navigation button.

Archive storage media include a choice of 100Mbyte ZIP drive or a PCMCIA ATA flash memory card.

The internal nonvolatile flash memory does not require battery backup, and data and configuration settings are saved during power outages.

The Daqstation DX100P and DX200P are equipped for use under harsh conditions, and comply with IEC529-IP65 and Nema No 250 Type 4 standards for dustproof and waterproof construction.