Having in view the permanently changing rules and regulations of the European and worldwide pharmaceutical and regulatory authorities (EMEA, USFDA, etc.) and because these regulations tend to be more and more strict, QPS comes into our customers help by offering from our partners a set of software solutions specially designed for pharmaceutical industry.
eCTD Manager Suite:
The eCTD (electronic Common Technical Document) specification is an international standard (is part of the ICH= International Conference on Harmonization ) for submitting electronic NDAs (New Drug Applications). eCTD Manager is an off-the-shelf submission management system of highest quality and functionality. It provides the eCTD functions of building, viewing, validating and publishing (electronic and paper) and enables the easy-to-use compilation of compliant electronic dossiers based on CTD, eCTD and other dossier structures.
The eCTD specifies the format and the structure of an electronic dossier. The benefits of eCTD include:
- Improved dossier quality
- Reduced preparation and update time for NDA, variations, amendments, etc.
- Fast access to documents for everyone who has access to the electronic dossier
- Shorter approval times which means reduced time to market
- Less paper quantity and lower logistics overhead
- Advanced archiving capabilities
eCTD Manager is the implementation of eCTD and much more. It ensures the fast and smooth functioning of an NDA with the following additional benefits:
- Living dossier
- Parallel work supported: inhouse and worldwide
- Intuitive user interface
- Advanced features for display, scanning and printing
- Compliant with 21 CFR Part 11
- Powerful navigating tools: links, private and public comments, bookmarks
eCTD Manager's visual structure editor allows you to compile a dossier step-by-step. Structural elements can be edited, added and deleted, and documents can be scanned, copied, moved or imported by drag and drop from other dossiers or files. Links, comments and highlights can be set at any time during compilation since documents are referenced relative to a structure element.
Once an eCTD based dossier has been approved by the agency, its Post Approval Maintenance Lifecycle starts which is adequately supported by eCTDmanager.
eCTDmanager has been designed with a client/server architecture allowing multiple users access to one dossier simultaneously. Parts of the dossier can be compiled at different sites and imported to a central site via a corporate network or via CDs/DVDs based on the eCTD specification. A sophisticated caching mechanism has been implemented especially for using eCTDmanager in globally distributed workgroups. This reduces network traffic and waiting periods. eCTD Manager can be easily integrated into state of the art document management systems such as DOCUMENTUM among others.
eCTD View - a read-only additional application of the eCTD Manager which enables viewing and printing of certain documents in a eCTD dossier or of the entire dossier, but without any possibility of making any changes in the text or on the documents included in that dossier.
eCTDcomfort - an additional application of the eCTDManager which enables the automatical generation of reference lists, the hyperlink overviews and additional reports.
DMSconnect - an additional application of the eCTDManager, which harmoniously integrates the documents in DOCUMENTUM or in LOTUS to eCTD Manager.
Doc Manager - application for automatical generation of the pharmaceutical dossiers for generics pharmaceutical industry.
Doc Validator - application for verifying the compliance of the documents with regard to a set of predefined corporate formatting standards.
DRA Manager - application which enables the Regulatory Affairs Manager to follow up the registrations and lifecycle management process for several pharmaceutical products and variations in different countries.
Pharmacovigilance software solution