The suite of applications has been designed to support all aspects of the preparation of CTD and in future eCTD dossiers for the registration of pharmaceutical products. It has been designed to provide specific functionality useful in the preparation of these dossiers through an intuitive user interface with a similar look and feel to the widely used Microsoft Office products. Like Microsoft Office it makes extensive use of xml to store dossier structural information and documents in a normal folder structure on the user’s personal computer or shared file server. As a result it integrates effortlessly with document management systems and avoids the pitfalls and risks associated with locking long lasting business documentation away in proprietary databases. With the focus is on providing the professional or trained administrative user with an affordable solution that specifically addresses the dossier preparation task using familiar information technology.
This development has been greatly facilitated by the contributions of a number of active user sites and although only two of the modules are in current commercial use, more than 50 product licenses have already been issued and a large number of CTD dossiers have been created and successfully submitted. eQALs addresses a specific need in the pharmaceutical industry for registering medicines. The regulatory body in South Africa requires documents to be submitted in a format known as Common Technical Dossier (CTD) and eQALS makes itself useful as an electronic CTD (eCTD) management software.
eQALS provides a suite of several applications covering all aspects of eCTD process. It can archive CTD dossiers along with their constituent documents at different points in their life cycle. It can track and maintain hyperlinks, even as their destinations undergo change. eQALS uses XML and regular folder structure to avoid the pitfalls of locking away important and long-lasting business documentation in proprietary formats. eQALS can interface with corporate document management systems such as Microsoft Sharepoint. eQALs has been developed using Visual Basic and .NET Framework 4 in Visual Studio with Gnostice PDFOne .NET providing important functionality.