SOURCE: QUMAS

May 22, 2006 08:00 ET

QUMAS Regulatory Advisor Receives RAC Certification

FLORHAM PARK, NJ -- (MARKET WIRE) -- May 22, 2006 -- QUMAS, the leading developer of enterprise compliance, governance and risk management solutions, today announced that Patrícia Santos-Serrão, a Regulatory Advisor in the Life Sciences practice, received her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).

According to RAPS, which administers the RAC testing and certification, "The RAC is indicative of the professional and technical abilities that are vital in this time of increasing challenges and demands within the health product sector. RAC-credentialed professionals are among the current and rising leaders in regulatory affairs in industry, government and academic organizations."

The RAC examinations address laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions.

"We are honored to have another one of our own employees be RAC certified," said Paul Hands, CEO of QUMAS. "Ms. Santos-Serrão has a wealth of Clinical and Regulatory Affairs experience that has been an asset for both our company and our customers. She has furthermore given us an inside scope on the industry's multi-layered content management and submission management needs, which only a world-class compliance solution like QCompliance can resolve."

Patrícia Santos-Serrão joined QUMAS last year as a Regulatory Advisor specializing in Life Sciences with a focus on Clinical and Regulatory Affairs processes. She has been in the Life Sciences industry since 1994 starting her career at Schering-Plough in Kenilworth, NJ, and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT, both in RA. Having had experience with global submissions both paper and electronic over eight years, Santos-Serrão moved into the solutions provider sector joining CDC Solutions, which was later acquired by Liquent, and CSC as a Business Process Specialist and Regulatory Specialist. She has assisted various customers during her time at CDC Solutions, Liquent and CSC in compiling eCTDs, and other submission format filings worldwide.

QUMAS QCompliance Suite

The QUMAS' QCompliance 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 QCompliancePortal™, which provides a role-based point of access, the QCompliance Suite includes two complete software applications -- QDocCompliance™ and QProcessCompliance™.

About QUMAS

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' QCompliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way.

For more information visit http://www.qumas.com.

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Contact Information

  • Contacts:
    Michael Kane
    Director of Marketing
    QUMAS
    (978) 257-2179