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Medical Device and Drug Development Compliance Specialists

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Document Management – Life Cycle Management



Implementing an Electronic Document Management System (EDMS) is now a basic requirement for most companies, as a result of the growing need to manage and share valuable information as part of daily working processes.

The most current needs to be addressed by an EDMS are the following:

  • Management of large volumes of documents and control of edition rights on the system, so that no validated document can be modified unless it is formally revised
  • Management of all document statuses and on-line access to the latest applicable version of each document
  • Configurable signature cycle depending on the type of document
  • Easy search and browsing in the system for all profiles of users
  • Definition of a comprehensive documentation structure (by business unit, by department, by region/site, etc.)

Ennov5 Exceeds These Requirements

Ennov5 Doc handles all types and formats of documents. The complete lifecycle is managed in the system:

  • Documents are prepared (entered or originated)
  • Reviewed
  • Signed
  • Distributed
  • Assigned
  • Revised or cancelled
  • Obsolete versions are automatically archived

Different rules can be defined depending on the types of documents, for example the number of mandatory signatures, predefined lists of recipients, confidentiality, etc.

When viewing or searching documents, you can choose multiple criteria in order to focus on the information that concerns your department, activity or function. Ennov includes advanced search features thanks to the Pertimm module. The Dossier module enables the consolidation of different documents (up to several hundreds) into a single composite document that can be published in paper of electronic format. The Dossier’s life cycle will be managed in much the same way. The PDF conversion module automatically converts Office source documents in PDF format, to facilitate on-line consultation and viewing preventing any modification.

And More?

Ennov5 Doc provides collaborative work features that help your personnel communicate on documents. A check-in / check-out system enables several contributors to work on the same document before it is sent for approval. Users can also make comments on documents, in particular suggestions for the next revision. Key information such as document title, reference, version number and application date can be automatically updated in the document itself using bookmarks. The definition of user profiles enables you to filter documents presented to the connected user depending on his/her rights and interests.
Ennov5 Doc makes a difference on the operational performance of your business:

Autonomy: The application can be configured after a two day training session, with no need for I.T. skills. You can move very quickly to implement and customize your system.

Flexibility: Your documentation system can be easily adapted to organizational changes.

Easy roll-out: Ennov5 is a web-based application, you have nothing to install on the users workstations, and any standard Internet browser is enough.

Return on investment: The benefits you draw from Ennov5 directly impact your company as a whole and help you optimize working procedures in a short time. This guarantees an outstanding ROI.

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