Batch validation meets FDA record requirements
A
Yokogawa product story
Edited by the Engineeringtalk editorial team
Aug 30, 2000
A batch validation package that complies with the latest FDA requirements on the storage of electronic records in the pharmaceutical and biotechnology industries has been introduced by Yokogawa.
A batch validation package that complies with the latest FDA requirements on the storage of electronic records in the pharmaceutical and biotechnology industries has been introduced by Yokogawa.
The new batch system, offered as an option on Yokogawa's Daqstation DX100/DX200 paperless recording system, provides electronic signature and data security facilities that comply with FDA requirement 21 CFR Part 11.
In addition, it is supplied complete with a validation document covering installation and operational qualification.
The Daqstation DX100/DX200 are versatile data-acquisition systems which feature high-resolution colour TFT displays and can store data in a variety of formats.
They can be operated in stand-alone or networked mode, and their PC compatibility means that data can be transferred to spreadsheets or other software packages.
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