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Dossier formats
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| eCTD – electronic Common Technical Document |
X |
X |
| NeeS – Non eCTD electronic submission |
X |
X |
| vNeeS – veterinary Non eCTD electronic submission |
X |
X |
| Paper CTD (PDF) – Common Technical Document |
X |
X |
Building and publication functions
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| Dossier storage and archiving |
X |
X |
| Generation of publication |
X |
X |
| Hyperlink & bookmark management |
X |
X |
| Internal validator (before and after publication) |
X |
X |
| Table of content, header, footer and numbering management |
X |
X |
| Publication visualization |
X |
X |
| eCTD sequence management (dossier lifecycle) |
X |
X |
| Collaborative work (check-in / check-out) |
X |
X |
Specific to paper dossiers
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| PDF publication (paper publication) |
X |
X |
| Automatic volume creation |
X |
X |
| Creation and printing of margin hyperlinks |
X |
X |
Other functionalities
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| 21 CFR part 11 traceability |
X |
X |
Settings and configuration
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| Document and dossier type configuration |
X |
X |
| Completely configurable system |
X |
X |
| Ennov Doc EDM software – pre-configured |
X |
X |
| Ennov Process option |
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X |
| eCTD import module Option |
X |
X |
Support and maintenance
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| Technical support |
Included |
Contract |
| Minor updates |
Included |
Contract |
| Major updates |
Included |
License |
Server settings
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| Secure data center |
X |
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| Data backups |
X |
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Costs
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| Monthly or annual subscription |
X |
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| Per sequence subscription |
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| Training |
X |
X |
| First publication follow-up offer |
Option |
Option |
| Adaptation of initial configuration |
X |
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| Complete configuration according to your specific needs |
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X |
| Perpetual license |
|
X |
| Annual support and maintenance |
|
X |
| Installation |
|
X |
| Database administration |
|
X |
| Server / operating system / database |
|
X |
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Contact Us |
