Report confirms recorders' FDA compliance

Edited by the Engineeringtalk editorial team May 24, 2002

Yokogawa has received independent confirmation that its Daqstation DX100P and DX200P paperless recorders meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11.

Yokogawa has received independent third-party confirmation that its Daqstation DX100P and DX200P paperless recorders meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11, covering the storage of electronically produced data in the pharmaceutical industry.

A new White Paper, authored by Stelex of Bensalem, PA, USA, provides a comprehensive review of the requirements of 21 CFR Part 11, and demonstrates, with the aid of stringent validation testing, how the Daqstation recorders achieve compliance.

Stelex is a specialist provider of information and consultancy services related to FDA regulations.

"They have a thorough understanding of FDA regulations and industry accepted software standards within the changing technological and regulatory environments", comments Yokogawa's David Jones: "And the fact that they have lent their name to this White Paper confirms our leading position in this key market sector for electronic recording systems".

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.

Login 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.

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.