FRAMINGHAM (09/19/2003) - Open Text Corp. this week announced enhanced support for Adobe Acrobat PDF files within its collaboration and knowledge management Livelink software.
The new offering, called Livelink Review Manager for Acrobat, provides a way for life science companies to securely carry out multiple simultaneous reviews of regulatory documents that are in PDF format.
Support for PDF files has been added to take into account the way life science companies handle regulatory documents over the course of time, according to Open Text.
Documents associated with drug development and discovery are often created in Word. Early on, when these documents are shared among internal staffers for reviewer, there are often many comments added and extensive content changes made. Word is ideal for these activities.
However, "in later stage reviews of these documents, companies prefer PDF," says Martin Sumner-Smith, Open Text's vice president of Pharmaceutical & Life Sciences Solutions. He notes that later in the life cycle of regulatory documents, there are fewer content changes that need to be made. For instance, a document might be passed around soliciting final comments and approval.
In this later stage, there is often a desire to have tighter control over the document. And that's where Acrobat plays a role. Sumner-Smith notes that Acrobat offers security features such as the ability to prevent the printing of a document.
In a typical usage scenario, Livelink Review Manager for Acrobat would collect the comments of multiple reviewers into a separate file. The comments would include information about the each reviewer and the time and date that person's comments were made. This provides a comment audit trail -- something that might prove useful when trying to meet or demonstrate 21 CFR Part 11 regulatory compliance.
Livelink also lets managers selectively set access and permission rights. Specifically, a manager can specify which users have the right to view, modify, or add comments to a document.
Livelink Review Manager for Acrobat will be available later this month.