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 |
| 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
| 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 data mart capabilities |
Search
| Solr search engine (as used 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 |
Mobility
| iPad app for document management |
| View and sign your document from anywhere |
| Offline synchronization |
| Available as a cloud-based deployment |
| Full web based browser independent solution |
| Local language capability is ideal for multi-site deployment |
Information system integration
| 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 (ERP, MDM (Master Data Management), PLM) |
| Email and scanner connectivity |