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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 partner Extedo a set of software solutions specially designed for
pharmaceutical industry. Amongst the software solutions we can offer, the following can be mentioned :
1. eCTD Manager Suite:
e-CTD Manager
 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:
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Improved dossier quality
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Reduced preparation and update time for NDA, variations, amendments, etc.
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Fast access to documents for everyone who has access to the electronic dossier
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Shorter approval times which means reduced time to market
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Less paper quantity and lower logistics overhead
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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:
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Living dossier
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Parallel work supported: inhouse and worldwide
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Intuitive user interface
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Advanced features for display, scanning and printing
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Compliant with 21 CFR Part 11
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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.
2. Document Management
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
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