RPS Master Files

Regulated Product Submissions | RPS Master Files

Please use this page for discussion. Do not delete other authors entries, but feel free to comment. When mature, this should become part of the story boards and business requirements. Use the signature --~~~~ to mark your own text.

This discussion should include two-way communication and referencing of Master files.

Two-way Communication of Master Files

TBD

Referencing of Master Files

TBD

Confidential/Public Use

One of the current problems with DMFs in eCTD format is the ability to label confidential items differently from public information -- there isn't a way to duplicate many of the eCTD hierarchy items to separate them. In RPS this should not be an issue -- and would be a key benefit -- as it can be done merely with a keyword. This may necessitate an extra keyword, e.g., "Confidential", being available over a majority of eCTD-style context of use items. --Joelfinkle 18:43, 19 August 2009 (UTC)