Regulatory full features

Submission for Human drugs

Paper CTD and Electronic submission in eCTD and NeeS formats
Sequence management and Variation control with modification indicators
Validation checker for submissions to the FDA, HEalth Canada, EMA and SwissMedic regulatory agencies
ICH Dossier template generator compliant with the ICH eCTD specifications for m2 to m5
Native Regulatory document management according to DIA EDM reference model
Hyperlinks and Study Tagging File (STF) management

Submission for Animal health

Electronic submission in vNeeS format
Sequence management and Variation control with modification indicators
Pharmaceutical, Immunoligical and MRL products
Validation checker for vNeeS version 2.2
Native Regulatory document management
Hyperlinks and PDF generation

Submission for Medical devices

eCopy submission management for 510(k) and PMAs
Original submission and hold notification review
Management of General and specific controls for Class I, II and III
Validation checker in compliance with the FDA eCopy program Guidance
Native Regulatory document management
Hyperlinks and automatic PDF naming

Regulatory Information Management Discover software

Planning and tracking system for regulatory activities
Submission management by product according to a geographic zone
Exchange with Health Authority
Product Registration capabilities, XEVMPD, IDMP, RPS, SPL
Overview on all regulatory activities

Compliance

Unique ID reference code generator
Double electronic signature for validation
Full audit trail 
ICH, GxP and FDA 21 CFR part 11 Compliant
Validation tool kit for all qualification required

Metrics

Automatic periodic reports
Data export in Excel and/or XML file
Real time dashboards
Statistics and other dynamic quality indicators
Business Intelligence and datamart capabilities

Search

Solr search engine (use by Google)
Full text search on document content and metadata
Advanced search form based on multi-criteria
Quick search tool available
Configurable views and search forms
iPad app for document management
View and sign your document from everywhere
Offline synchronization
Cloud environment available
Full web based solution compatible with every web browser
Fast multilingual and proven multisites capabilities

Information system integration Discover software

Available on the Cloud and on premises installation
Fully configurable, Turn key solution, No programming required
No IT skill required for administrators
Easy scalable deployment
API available to connect to any other software (Sales Forces, SAP, Product database, etc.)
Emailbox and Scanner connector
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