Product

eCTDmanager Suite

May 8, 2009

eCTDmanager is an off-the-shelf scalable all-in-one electronic submission management system for eCTD and non-eCTD electronic and paper submissions. It provides the functions of building, viewing, validating and publishing (electronic and paper) and enables the easy-to-use compilation of compliant submissions based on CTD, eCTD, IMPD and other submission structures.

Important features include:
• Business process excellence
• Intuitive and ergonomic user interface
• Advanced features for Life Cycle Management and Control
• Compliance with 21 CFR Part 11 Management, submission component display, document scanning, paper publishing and Study Management.
• Ability to start simply without using a Document Management System and grow to integrate with your DMS
• Advanced audit trail
• Powerful Hyperlinking capabilities:
– cross links
– powerful management of hyperlinks
– resolution of external hyperlink
– hyperlink to bookmarks
– automated text to hyperlink functionality according to certain technical writing standards and more
• Clone submissions
• Easily reuse submissions for another region
• Sophisticated replication facilitates collaborative working in globally distributed workgroups
• Integrated validation procedure and tracking functionalities for eCTDs
• Management and generation of Study Tagging Files

eCTDmanager optionally incorporates a sophisticated replication mechanism that provides globally distributed workgroup users with simultaneous access to a submission. This also reduces network traffic and delay. eCTDmanager can be easily integrated into document management systems such as:
• CSC (formerly FCG) First Doc, First Point
• EMC Documentum Content Manager
• IBM Score
• Lascom
• Microsoft Sharepoint
• NextDocs
• OpenText Livelink
• QUMAS DocCompliance
• and others

eCTDmanager has a powerful hyperlinking engine that automatically handles the detection, notification and correction of broken hyperlinks and many other features. Plus an integrated validation function (at no extra cost) ensures compliance of the generated submission to ICH and regional specifications.

Life cycle Management of Pharmaceutical Submissions
eCTDmanager’s visual structure editor provides users with the ability to build and review submissions without knowledge of XML technology.

Structural elements can be easily added, edited and deleted. Documents can be scanned, copied, moved or imported by ‘drag-and-drop’ from the file system or from most DMS’. Hyperlinks and comments can be set at any time during submission compilation.

Once an eCTD-based dossier has been approved by the agency, its post approval maintenance life cycle starts. eCTDmanager provides unique visual and contextual aids to ensure rapid response and accuracy.

Application Benefits
Working with eCTDmanager ensures a fast and accurate generation and life cycle management of your submission (electronic and paper). Your main advantages for using eCTDmanager are:
• process efficiency
• cost reduction and
• faster time to market

These advantages are reached by:
• improved submission quality
• reduced preparation and update time for original applications, variations, amendments, etc.
• fast access to documents and eCTD status for everyone involved in the project
• reduction of paper and lower logistics overhead
• support of parallel work locally and worldwide
• sophisticated management of hyperlinks