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Medical Device and Drug Development Compliance Specialists

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Dossier (Regulatory Affairs Submission)


Dossier helps you create, assemble, update and publish a composite document(s) from various individual document sources and formats.

A compound document is resulting from a dynamic merge and assembly of elementary documents monitored by a structuring and publishing agent (the Dossier module). Elementary documents might be of heterogeneous types and formats. They should be managed as a whole. For instance, a training manual can be made up of Word documents, Powerpoint presentations, Excel spreadsheets and a video tape. It is published and made available to all users as a single document.

Does your business activity require that you merge various files created in different formats by several authors in a single and consistent dossier, with its own publishing rules, page numbering, headers, footers, table of contents, indices? Then Ennov5 Dossier is meant for you. Technical documents and marketing authorization submission dossiers call for tender, press and media kits: all these documents are managed as a single, consistent, structured and unified document. No more time wasted on assembling and maintaining a constantly moving document means immediate return on investment.

Each document or sub dossier follows its own lifecycle. Individual changes update in real time the whole dossier, up to the moment you decide to freeze and publish it. Several authors can work in parallel. Dossier allows various combinations of the same content in order to adapt to different contexts or targets: FDA approval, other regulatory approval, suppliers/customers needs, auditing purposes, etc.

Dossier offers both sophisticated and easy-to-use features

Thanks to its user friendly drag-and-drop interface it can manage documents stored in Ennov5 Doc as well as external documents. To structure a dossier, all you have to do is to specify what parts, chapters sections you want the dossier to be split into and then drag-and-drop. The dossier author describes layout elements rather than ask for publishing. This operation starts dossier version numbering. Publishing can be done in paper (PDF) or electronically. Dossier is eCTD compliant.

Up and running from the moment you install it, Dossier is a key tool to simplify and secure document management. It includes all benefits you have using Ennov5 Doc and adds the ability to manage even more complex documents, compound dossiers. Time saving and safeguarded against potential mistakes and oversights: this is what Dossier will do for you!

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