Greetings, faithful eCTD readers. Sorry for the delay in posting but as many of you know, the vacation season was upon us! Although the break was nice, my inbox didn't stop accepting messages and I'm presently digging my way back out.
In any event, as regulatory groups start analyzing their needs regulatory tracking systems are emerging as a component that can assist with regulatory affairs planning and commitment tracking. Particularly in global organizations where local operations are handled by remote branches that are note well connected to headquarters, there is not always a good understanding across sites of details such as submission status, and in some cases, local brand name.
As these systems become standardized, integration with publishing systems is a logical step. The question -- which way does the integration work?
- Do tracking systems act as the staging area where submission details (and in the case of eCTDl, submission metadata) is planned, and then pushed to the publishing system as a stub or template publication, OR
- Do publishing system automatically recognize information that has been published, and simply reflect the actions taken by the publishing team?
Although both may be possible, ultimately this is a bit of a chicken and egg question -- which is the logical starting point of a submission? The tracking system, or the publishing system?
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