BUCHI NIRWare - Manual (Page 298)

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NIRWare Suite NIRWare 1.5 Software Manual
6.8. Lifecycle
6.8.1. Lifecycle introduction
NIRWare has been designed to comply with 21 CFR Part 11. The Lifecycle model is the core of this
compliance.
The Lifecycle approach enables to control the user access to the NIRWare software, transitions from one
lifecycle state into the other and to keep a history of actions done (Audit Trail).
The following picture shows the principal lifecycle configuration. There are three relevant modes:
1. Upper right quadrant: this is the part of editing or developing electronic records
(calibrations, applications etc.). The electronic records are in an edit state and can be
changed. This area is in the write mode and is not GMP relevant.
2. Upper left quadrant: this is the part of testing calibrations or applications. This area is
read only but it is not GMP relevant.
3. Lower left quadrant: in this part the electronic records are in routine use, after approval for
it. This part is read only and it is GMP relevant.