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Mar 11, 2016

Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

Learn to use a quality management system at a 
cross-enterprise level during the Proactive 
GCP Compliance Conference


MasterControl Expert Addressing Proactive GCP Compliance Conference Audience Next Week


by Robyn Barnes
Marketing Communications
MasterControl

You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?


Patricia Santos-Serrao, MasterControl’s market segment director, will be covering that topic at 8:45 AM Wednesday, March 16 at the Proactive GCP Compliance Conference at the Sonesta Hotel Philadelphia in Philadelphia, PA. 

Santos-Serrao will cover four main points in her presentation:
  • What is a quality management system (QMS)?
  • What FDA is saying about “quality in clinical trials”
  • What is a clinical quality management system (CQMS)?
  • CQMS & CTMS:  complementary solutions


This article is related to the White Paper: FDA Inspections of Clinical Investigators: Are You Ready? To get the full details, please download your free copy.


“Your average QMS system on the market today will have modules covering documents, training, quality event management and analytics,” she says.  “Some might have supplier management and audit management, too.  These systems are most commonly used in the manufacturing industries to manage the quality of product output and they are well-suited for that.”

“However, they don’t address the research aspect very well.  That’s where clinical quality management thinking comes in.”

Santos-Serrao stresses that “Quality does not end at clinical quality. It doesn’t end with writing stand operating procedures on clinical activities or training users on procedures.  Quality must be embedded in clinical operations.  Having two separate systems for clinical QA and clinical operations creates silos and inoperability that impedes the ability to embed cross-functional best practices across clinical research.”


For more information about this meeting, visit the conference website.


Patricia Santos-Serrao is a senior product manager at MasterControl with nearly two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.

Prior to joining MasterControl, Santos-Serrao was the manager of global regulatory solutions for QUMAS, where she helped drive the development, sales, marketing and implementation of solutions for pharmaceutical R&D, with a particular focus on submission document management. She has worked for several Tier-1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim. She has also assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs and other submission format filings worldwide.

Santos-Serrao earned her bachelor’s degree in business administration at Western Connecticut State University and University of Phoenix. She has earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA).





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