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

Document ID

Document ID TE1087

Published Date

Published Date 01/24/2019
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Question
Is the software used on the DR 3900 and DR 6000 spectrophotometers in compliance with Title 21 CFR Part 11?
Summary
Compliance of the DR 3900 and DR 6000 spectrophotometers with Title 21 CFR Part 11
Answer
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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