Regulatory documents, like CTDs and eCTDs, are the product of complex review and edit cycles that involve multiple authors in different locations. The review process requires that a document be distributed, tracked, and reconciled into a new version. i4i provides a number of tools that greatly simplify this process.
Document DistributionUsers must be aware of the documents they should be working on, as well as have easy access to these documents, in order to have a successful review process. Forcing them to search through repositories for documents can waste time and result in missed work. With ALiCE (i4i's Authoring Lifecycle Collaboration Environment), the user simply opens the "My Assignments" folder in Windows Explorer and has access to all documents that are ready for them to work on.
Document TrackingALiCE allows management to track, in the familiar environment of Microsoft Project, the entire life cycle of documents and projects. Managers can track progress on a document-by-document basis as well as by document grouping. For example, five documents about quality are grouped into a folder called 'quality-overall-summary'. The progress of all documents within this folder, as well as each of the individual documents, is tracked, providing complete project tracking. Microsoft Project displays the completion status of projects based on the rate of progress on the individual documents within it.
Document ReconciliationReconciling content changes from the vast number of documents generated during a review cycle is an arduous and time consuming task. ALiCE solves this problem; all comments and content changes from the numerous drafts of a document can be consolidated into a new version of the document in one easy step. Then, using an editing tool such as i4i's x4o, changes and comments can be accepted/rejected or deleted from the one, single new version created.
Click here for more information on ALiCE.