Module 12 2019

Life Cycle Management

Within a sequence, documents are submitted.

Per document a different operation attribute is assigned. The operation attribute defines if the document is:

New = no relationship with files submitted previously

Append = there is an existing file to which this new file should be associated (Advise is not to use append!).

Replace = there is an existing file that this new file replaces

Delete = no new file is submitted – leaf mentions that it is ‘deleted’

The Organisation for Professionals in Regulatory Affairs

Slide 71