eCTD manager


We are working on is an electronic system to register (new) drugs for Southern African countries. If the prospective programmer knows something of the process, it will be a great help. It consists of a "Client and Server" side functionality.

Client side:

Basically a file structure is created in a uniform way (see [url removed, login to view] ) and then populated with required documents, mainly in pfd format, but may contain any standard document type including MSword, Xls, Graphics, etc. All documents are index and a TOC is then made in XML format file.

Changes to these documents can be made and must be documented as ver. 1, ver. 2...n. This will be done in a multi-user environment.

The documents must be change sensitive. When more than one user work on the document any changes must be reloaded for each user, if required.

The user interface must be "Friendly" and the user does not need to know we are working on folder Module which is the IHC numbering system, if we describe what the drug is used for.

Server side:

All this is then electronically submitted to a Government agency where it is entered on a database (see electronic FDA submissions <[url removed, login to view]>


Once received various parts of the final document are distributed to different departments. Clinical data goes to clinical evaluation etc.

Many quires may be lodged and attached to part(s) of the final document and responses on these may be attached on top of the query, etc. We should keep track of the tree of correspondence.

Yes and there can be more !

Best regards,

Johan Swanepoel

pharmasoft@[url removed, login to view]


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( 1 comentário ) South Africa

ID do Projeto: #2972671

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