Is the software used on the DR 3900 and DR 6000 spectrophotometers in compliance with Title 21 CFR Part 11?

Dokument-ID

Dokument-ID TE1087

Veröffentlichungsdatum

Veröffentlichungsdatum 24.01.2019
Frage
Is the software used on the DR 3900 and DR 6000 spectrophotometers in compliance with Title 21 CFR Part 11?
Zusammenfassung
Compliance of the DR 3900 and DR 6000 spectrophotometers with Title 21 CFR Part 11
Antwort
With regard to the software controlling the user interface of the DR 3900 and DR 6000 spectrophotometers, the software has features that support the accreditation for 210 CFR Part 11. However, this accreditation must be done by the user. This includes the administration management of the PC that the communication software is installed on.

With regards to the communication software, including the Remote Operating Software (Product # LZV938) or any other data transfer method, there is no user rights management. This must be accounted for by the user's computer.
 

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