White Paper provides independent verification that paperless recorder products meet requirements on electronic records and signatures
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, 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
Stelex is a specialist provider of information and
consultancy services related to FDA regulations.
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 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
Full access to the recording system is provided by
the administrator log in, of which there are three.
is set up by the administrator, who also determines the rights of
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
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.
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.
information is stored as an attachment to the measurement file in
order to protect the original data.