January 31, 2007 08:41 ET

QUMAS to Offer Complimentary Compliance Consultations on How to Best Publish Life Sciences Dossiers at DIA EDM Conference

Patricia Santos-Serrão to Discuss How Life Sciences Firms Can Incorporate Sound Document Management for Regulatory Publishing

FLORHAM PARK, NJ -- (MARKET WIRE) -- January 31, 2007 -- QUMAS, a leading developer of quality management and regulatory affairs solutions, today announced that Patricia Santos-Serrão, RAC, regulatory affairs advisor at QUMAS, will provide 30-minute complimentary consultations at the Drug Information Association's (DIA) 20th Annual Conference for Electronic Document Management (EDM). Santos-Serrão will provide insight into establishing sound document management processes when publishing life sciences dossiers. The conference will take place February 6-8 at the Loews Philadelphia Hotel, Philadelphia, PA. Over the past 20 years, the DIA EDM Conference has served as a platform for the discussion of emerging standards and processes for the creation, submission, and retention of regulatory information.

During her consultation sessions on Wednesday, Feb. 7th and Thursday, Feb. 8th at the QUMAS booth #106, Santos-Serrão will discuss best practices in the following areas:

--  Electronic Content and Submission Archive Management
--  Content and Submission Lifecycle Management
--  Content and Attribute Reuse for eCTD
--  Compliance and Validation Issues and Challenges
--  Change Control
--  SOP Management
"These 30-minute sessions can prove invaluable to companies attending the DIA EDM Conference," said Ken Hayward, vice president of Life Sciences at QUMAS. "Patricia has an exceptional background in helping pharmaceutical and biotech companies address regulatory publishing challenges to submit bulletproof dossiers. Tapping into Patricia's insight and expertise can very well help a company in making submission of its next dossier a success." For more about Patricia Santos-Serrão, click here. (

Interested compliance, document, regulatory affairs and R&D managers who are engaged in EDM and looking for improvement and efficiency in their content and submissions lifecycle management should take advantage of this on-site, value-added service. The number of consultation sessions is limited. Individuals interested in scheduling a free 30-minute session with Santos-Serrão can do so by calling 800-577-1545, or by visiting the QUMAS booth at the DIA EDM conference.

About QUMAS Compliance Suite

The QUMAS Compliance Suite enables life science companies to effectively manage the creation, review, approval and revision of the content; efficiently interact with submission management systems; and, ease the process for handling Process Change Control, Adverse Events and other data-centric requirements. The QUMAS web-based application suite enables organizations to consolidate and manage their regulatory compliance requirements through a configurable enterprise software suite. Accessed through the CompliancePortal™, which provides a role-based point of access, the Compliance Suite includes two complete software applications -- DocCompliance™ and ProcessCompliance™.


QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS' Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way.

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