BUCHI NIRWare - Manual (Page 226)

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NIRWare Suite NIRWare 1.5 Software Manual
The following dialog opens:
Four different template types are provided:

Electronic Records/Signatures: Covering all requirements of 21 CFR Part 11 (relevant for
pharmaceutical applications)
This template is only available together with the NIRWare Advanced License or with the
additional NIRWare Regulatory Kit License. It is designed for user in a regulated
environment who work with electronic signatures and records.

Electronic Records: For user in a regulated environment, who do not work with electronic
signatures but with electronic records. This template is only available together with the
NIRWare Advanced License or with the additional NIRWare Regulatory Kit License.

Unregulated: For users in unregulated environments, who do not work with electronic
signatures and records.

Custom Settings: Customer specific settings, which are generated on request by BUCHI
Labortechnik AG (for information on how to import a corresponding template, see
Lifecycle Configuration )
If you highlight a template type, a detailed explanation of its characteristics is displayed in the area below.
To change the lifecycle template, highlight the desired template and click the Save button or double-click
the desired template.
The dialog "Authorize with your signature" opens. Type in your user name and password and click the
Okay button (green arrow).
When changing the lifecycle template to a more restrictive one, the following message appears