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

Document ID

Document ID TE1087

Published Date

Published Date 05/27/2017
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Question
Is the software used on the DR 3900 and DR 6000 in compliance with Title 21 CFR Part 11?
Summary
Software on DR 3900 and DR 6000 in compliance with Title 21 CFR Part 11
Answer
The software has features that support the accreditation for 210 CFR Part 11, but the accreditation must be done by the user, which includes the administration management of the PC that communication software is installed on.

User rights management is not included in the Remote Operating Software Photometer (catalog number LZV938) or the other data transfer methods, so must be accounted for by the user's computer already.

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