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Downloading - Weber Marking Systems

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Setting Label Mode (Meaning Level)<br />

10. User and Administrator Reference (FDA 21 CFR Part 11)<br />

One of the new properties added to the label document is the Label<br />

Mode. During initial creation, you should set the mode to Authorship.<br />

After reviews, you should progressively set the mode through Review<br />

and Approve (and perhaps also Responsibility). Authorship is<br />

considered the lowest mode and Responsibility the highest.<br />

You can set any mode at or below your permission level. In the<br />

following screen, if you had Authorship permissions you could only<br />

set the Author mode. If you had Responsibility permissions, you<br />

could set any of the levels of label mode.<br />

Legitronic does not require you to set the label mode. It offers this<br />

setting for client use. You can change Label Mode on only a new<br />

label file or a work file. You cannot edit a read-only archived version<br />

of a label file.<br />

Legitronic User Manual (v3.4) 133

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