Electronic and Paper Publishing All in One Application!

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

 Related EXTEDO Applications:

• RLPmanager™ – Report-level publishing with Hyperlinking and Study Management
• eCTDmanager view™ – A submission viewer tightly integrated with eCTDmanager and its Submission Life Cycle database
• eCTDmanager review™ – A submission reviewer tightly integrated with eCTDmanager with additional annotation functions
• DMSconnect™ – A configurable standardized connector for leading Document Management Systems
• miniDMS™ – A basic layer for version control and LC management of regulated documents
• DOCmanager™ - A management component to maintain master submissions and associated regional submissions
• PcVmanager™ – Electronic management and reporting of adverse events based on the E2B standard
• PLmanager™ – Native authoring and management of PIM and SPL labeling documents
• CTmanager™ – Electronic management of Clinical Trial Applications
• DRAmanager™ – Integrated control and tracking of life sciences products and associated regulatory affairs processes
• DOCvalidator™ – Automated Document Format Compliance check for Word and PDF documents
• EURS is Yours™ – The Agency eCTD Review and Validation System

Documentum is a trademark of Documentum, a division of EMC Corporation; DocCompliance is a trademark of QUMAS; Livelink is a trademark of OpenText. All other trademarks, trade names and service marks are the properties of their respective owners.