Comparison of offers

Essential Premium Enterprise
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Dossier formats

eCTD – electronic Common Technical Document X X X
NeeS – Non eCTD electronic submission X X X
vNeeS – veterinary Non eCTD electronic submission X X X
Paper CTD (PDF) – Common Technical Document X X

Building and publication functions

Dossier storage and archiving X X X
Generation of publication X X X
Hyperlink & bookmark management X X X
Internal validator (before and after publication) X X X
Table of content, header, footer and numbering management X X X
Publication visualization X X X
eCTD sequence management (dossier lifecycle) X X X
Collaborative work (check-in / check-out) X X X

Specific to paper dossiers

PDF publication (paper publication) X X
Automatic volume creation X X
Creation and printing of margin hyperlinks X X

Other functionalities

21 CFR part 11 traceability X X X

Settings and configuration

Document and dossier type configuration X X X
Completely configurable system X X X
Ennov Doc EDM software – pre-configured X X X
Ennov Process option X
eCTD import module Option X X X

Support and maintenance

X X X
Technical support Included Included Contract
Minor updates Included Included Contract
Major updates Included Included License

Server settings

Secure data center X X
Data backups X X

Costs

Monthly or annual subscription X
Per sequence subscription X
Training X X X
First publication follow-up offer Option Option Option
Adaptation of initial configuration X X
Complete configuration according to your specific needs X
Perpetual license X
Annual support and maintenance X
Installation X
Database administration X
Server / operating system / database X
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