September 18, 2007 08:16 ET

QUMAS to Demonstrate eCTD-Ready R&D Solution at the RAPS 2007 Annual Conference & Exhibition

Regulatory Affairs Focus Contributing Author Patricia Santos-Serrao to Discuss How Life Sciences Firms Can Improve Their Compliance Initiatives

FLORHAM PARK, NJ--(Marketwire - September 18, 2007) - QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced that it is participating in the RAPS 2007 Annual Conference & Exhibition to be held in Boston at the Hynes Convention Center September 23-26, 2007. In booth #414, QUMAS will demonstrate its QUMAS R&D Solution, designed to help life sciences companies bring new drugs to market quickly and cost-effectively within a secure and controlled environment.

The QUMAS R&D bundle is an out of the box solution that assists life sciences companies in expediting the new drug application process with better quality submissions, fewer iterations, and shortened review and approval cycles for IND and NDA submissions. The R&D Solution has seen rapid adoption within the industry due to its best-of-breed software for:

--  Regulatory Content Management
--  Submission Management
--  Browser-based Collaboration
--  eCTD (electronic Common Technical Document) Authoring Templates
--  Import/Export Tool

On hand to discuss the R&D Solution will be Patricia Santos-Serrao, RAC Regulatory Advisor at QUMAS, whose article, "The High Cost of Noncompliance in the US Pharmaceutical Industry," appeared in the August issue of Regulatory Affairs Focus, the monthly publication for RAPS members. The article recommends that regulatory affairs professionals increase their knowledge of compliance statues enacted by agencies other than the FDA, such as the edicts enacted by Environmental Protection Agency (EPA) and the Securities and Exchange Commission (SEC). This is the second time in a year that Santos-Serrao's work has been printed in Regulatory Affairs Focus. In October 2006, her article "Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing" detailed the many benefits of using an electronic document system (EDM).

In the QUMAS booth at the conference, Santos-Serrao and other QUMAS industry experts will be able to discuss the following hot topics:

1. Selecting and implementing solutions for preparing functional areas to author documents in eCTD format and granularity

2. Understanding different approaches to implementing solutions for Electronic records management as well as requirements for Electronic signatures

3. What the impact of the January 1, 2008 deadlines for eCTD will be on their companies and processes

4. Should we invest in building capabilities for compiling eCTD in house or outsource submissions?

5. How the shift to a more controlled document management strategy will impact collaboration with external partner such as CROs

"For the past decade, QUMAS has been helping life sciences companies navigate through a thicket of ever-evolving regulatory forces," Santos-Serrao said. "In addition to the R&D solution, QUMAS quality management systems have helped numerous brand name companies with their SOP Management (Policies and Procedures), policy training and certification, CAPA, deviations, customer complaints, change control and other issues. Anyone who is serious about improving their compliance efforts should visit our booth for a consultation."

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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