Ennov Compliance platform
Enterprise Document Management Software
- Support of all documents types (including dossiers)
- Configurable workflows and electronic signatures
- Document control and version control
- Management of meta-data in multiple formats
- Document rendition / dossier publishing
- Controlled document distribution
- Easy-to-use views and search features
Unified Access to All Documents
All types of documents can be managed in the same Ennov database: Quality, Regulatory, but also R&D, Clinical, Engineering, Legal or Marketing. Each document has an ID form associated with it, it includes a set of metadata fields and displays the document history.
Field values are used to classify, filter and search documents. It is then very easy to structure the documentation and navigate in it; there is no need to create multiple databases, one for each domain. Document hierarchies can be set differently for each unit; users then access the content that is related to their function or interests.
Improved Productivity and Efficiency
Ennov manages the entire document lifecycle: creation, collaborative authoring, approval, distribution, revision/cancellation, archival. When a document is revised, the new version is created in draft status; it will become applicable after being signed by all approvers, the previous version is then automatically archived. Approval workflows are entirely configurable, they can be skipped in case you incorporate existing documents into the system. If large volumes of documents or dossiers have to be imported, Ennov proposes data migration services, this ensures a smooth transition to the new system.
Documents and dossiers managed in the Ennov EDMS can be linked to records managed in other modules (e.g. a Change Control in Ennov Process or a Regulatory Activity in Ennov RIM). Each view of documents has its own URL that can be inserted in an Intranet portal, for example.
A dedicated server converts documents into PDF format and dossiers into CTD, eCTD, NeeS, vNeeS and eCopy formats. Compliance with regulatory requirements is then guaranteed. Print control features can be activated if needed for specific document types such as batch files.
Document management is a key component of the Ennov platform.
Ennov’s unified compliance platform is a highly configurable software architecture that combines business process management, document management, data/forms management, learning management and business intelligence to form the foundation on which our applications are constructed.