Many companies thought that by acquiring eCTD publishing, all of their submission problems will be solved. Unfortunately, after ten or more sequences it becomes clear that the connection between original documents and published eCTD is lost, and they continue with life of their own. Initially copied document may have gone through several versions, but in eCTD it is still the first one, which was copied. And vice versa, based on regulatory agencies requirements, RA personnel changed some documents (in most cases specifications) without letting it be known to the document author. In both cases the result is the same – serious problem.
How to overcome this? By introducing integral, company-wide EDMS, with eCTD publisher just a tiny part of it. In this case, every single document has a lifecycle of its own, which is reflected in eCTD structure, since the documents are not copied, but linked in eCTD. What does it mean? It means that for each document there is only one, valid version in the system. Each document is typically owned by its author, who knows everything about it. If the document has to be changed, change request is issued by interested party, and the author changes the document accordingly. On the other hand, if the document is changed by the author because of departmental needs, he can see where this document is used (specification for excipient can be used in hundred of dossiers) and act accordingly. At the same time, compiler of the dossier will see that the old version of the document is linked in the dossier, so he can either leave it or change to new version, as the situation requires.
In this way, dossier will always be up to date, only qualified persons will be able to make changes, and managing of eCTD lifecycle will become much easier.
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Infotehna: eCTD as part of integral Electronic Document and Content Management System - Webinar
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