Easy configuration for complex needs
From a virtual document editor, which remains the essential tool for working with documents, P2 eCTD allows the creation of a submission that complies with authority-approved DTD. During the finalizing stage of eCTD, information-entry screens are automatically generated.
Controlling submissions' lifecyclesP2 eCTD manages the life cycle of the various sequences associated with many submissions by following the requirements set by the ICH. The actions New, Replace, Append and Delete are deduced automatically by checking the current status of the virtual document and the last sequence submitted when configuring documents in the eCTD. |
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P2 eCTD's sequence editor facilitates the management of submissions by displaying the different actions carried out. It allows efficient control of the content of each sequence, which can be locked, unlocked or updated.
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Study reports, as STF, are managed through specifics elements to respond to ICH specifications. In this same way, every other type of eCTD document can be also easily integrated.
P2 eCTD also facilitates the management of links, within and between documents as well as between submissions. Hyperlinks can be created directly in PDF files using Acrobat, and then are managed by P2 eCTD. In order to guarantee the integrity of the document database, all management information is stored in the docbase.
Additionally, any faulty links are displayed, so that they can be quickly corrected
In this way of conformity, P2 eCTD allows the backbone to be generated and the submission exported so it may be communicated to the regulatory authorities.
The power of this product equally resides in the ability to integrate it with P2 to create one or several paper-based publishing configurations all, to be clear, without altering the eCTD's original content.
