Regulatory full features

Submission for Human drugs

Support for eCTD, CTD (paper) and NeeS submission formats
Sequence management and variation control with change tracking
Validation tool for submissions to the FDA, Health Canada, EMA, GCC and SwissMedic health authorities
Submission assembly templates compliant with the ICH eCTD specifications for m2 to m5
Integrated Regulatory document management aligned with DIA EDM reference model
Hyperlink and Study Tagging File (STF) management

Submission for Animal health

Electronic submission in vNeeS format
Sequence management and variation control with change tracking
Pharmaceutical, Immunological and MRL products
Validation checker for vNeeS version 2.2
Integrated Regulatory document management
Hyperlink management 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
Integrated Regulatory document management
Hyperlink management and automatic PDF naming

Regulatory Information Management Discover software

Planning and tracking of regulatory activities
Submission management
Health authority correspondence and commitment tracking
Product registration management, XEVMPD, IDMP, SPL
Automatic notifications for renewal and PSUR submissions

Compliance

Unique ID reference code generator
Two-step electronic signature verification
Full audit trail 
ICH, GxP and FDA 21 CFR part 11 Compliant
Validation toolkit for IQ, OQ and PQ verification

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 using multiple selection criteria
Quick search tool
Configurable and sortable search results display and views
iPad app for document management
View and sign your document from everywhere
Offline synchronization
Available cloud-based deployment
Full web-based solution is browser independent
Local language capability is ideal for multi-site deployment

Information system integration Discover software

Cloud-based or on-premises deployment options
Fully configurable, turn-key solution requires zero programming
No IT skill required for administrators
Highly scalable architecture
REST API to connect to other enterprise systems (CRM, ERP, PLM, etc.)
Email and scanner connectivity
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