BUCHI NIRWare - Manual (Page 306)

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NIRWare Suite NIRWare 1.5 Software Manual
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Electronic Records/Signatures
This template covers all requirements of 21 CFR Part 11. An electronic signature is required for all phase
transitions. Going from the checked state into the approved sate, the electronic signature must be given
by a different person (Constraint Signature). When signing electronically it is mandatory to enter a
comment giving the reason for the action. Everything is documented in the Audit Trail. Editing is allowed
only in the Create state. Editing the lifecycle data sets is not possible in the Checked and Approved
states.
Electronic
Records/Signatures Action Signature Comment Audit Trail Constraint
Signature
Create Copy
Delete
Edit
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Create Edit Save
Checked Copy
Delete
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Approved Copy
Delete
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