Lifecycle templates, Unregulated – BUCHI NIRWare User Manual
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NIRWare Suite
NIRWare 1.5 Software Manual
6.8.5. Lifecycle templates
The requirements for various industries are very different. Only GMP relevant areas of the pharmaceutical
industry must comply with all requirements of 21 CFR Part 11. On the other hand there are industries,
which are not affected by these requirements at all, e.g. Food&Feed industries. In order to simplify the use
of the implemented lifecycle model, there are three pre-defined templates available, which fulfill various
requirements.
The following description and tables summarize the settings for the different templates.
Unregulated
This template is for users who do not need to bother with the regulations. The settings are reduced to the
minimum. There are no Comments, Audit Trail entries and no electronic signatures needed. From the
create state the data sets are directly put into the approved state. With this template it is possible to edit
the data sets in the Approved state as well.
Unregulated
Action
Signature
Comment
Audit Trail
Constraint
Signature
Create
Copy
Delete
Edit
Next
Create Edit
Save
Approved
Copy