QUMAS unveils life science compliance platform

MAY 12–FLORHAM PARK, N.J.–QUMAS, provider of Enterprise Compliance Management solutions for the life sciences industry, has introduced e-DocComplianc for the Oracle platform, a Web-based application that manages the full life cycle of regulatory controlled documentation in compliance with FDA, including 21 CFR Part 11, EMEA, ISO and other international regulations.

Designed for deployment across multiple life sciences functional areas, key enhancements and features of e-DocCompliance for the Oracle platform include:

— Robust, flexible workflow engine enables users to define life cycle states and the most appropriate electronic signature requirements for each state.
— Full administrative functions, with security model; user profile manager; support for multiple roles/users; and fully configurable options for groups, document types, change categories, extended attributes, and more.
— Enhanced Audit Trail captures over 60 individual auditable events.
— Built-in reports, including Group Membership; Document Detail; Table of Contents; Annotation; Document Expiry; and more.
— Flexible change control with powerful workflow management; ad hoc workflow processing; controlled printing/watermarking; among others.
— 21 CFR Part 11 support, featuring unique non-biometric user ID/password e-signature authentication; comprehensive audit trail support; authority checks, etc.
— Advanced Search and Retrieval featuring user-definable saved searches; includes searches for documents, messages, full text search/retrieval, and more.
— Pre-defined technology integration with Adobe 5; Oracle 9i; Workshare Technologies’ DeltaView; Liquent k-Publisher; Microsoft SQLServer.


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