Opportunities for ensuring compliance and managing change: A next-generation platform strategy for regulated pharmaceutical laboratories
In association with Waters Corporation, Bioanalysis Zone is pleased to present a series of topical webinars highlighting the important challenges and information needs facing the bioanalytical community.
In the second webinar in the series, Steven Cubbedge and Dana Yurach (Waters) spoke about Waters UNIFI™ and how this integrated system for security and compliance tools can make a difference to bioanalysis and biopharmaceutical environments. During the webinar, Dana and Steven discussed the key aspects of data integrity, quality and authenticity and provided an overview of how the integrated compliance management system within the UNIFI Scientific Information System can be used to support these key activities.
With the introduction of Waters UNIFI™ Scientific Information System, an integrated system for security and compliance tools, is now available for bioanalysis and biopharmaceutical environments. This webcast covered the key aspects of data integrity, quality, and authenticity and to offer an overview of how the integrated compliance management system within the UNIFI Scientific Information System can be used to support these key activities.
Overview of key computerized system compliance concerns:
- Data integrity
Typical workflow examples of how UNIFI’s dedicated compliance management interface supports these critical aspects:
- Software deployment/computerized system validation
- Analytical instrument qualification
- Routine maintenance
- Change control for a software upgrade/instrument driver deployment.
- IT compliance professionals looking for best-in-class solutions
- Pharmaceutical laboratory managers interested in learning more about relevant IT compliance topics
- CRO managers and investigators concerned with data integrity
- General bioanalysis enthusiasts.
Sr. Product Manager, Informatics
Milford, MA, USA
Steve Cubbedge is a Senior Product Manager in the Informatics Marketing group at Waters. He is responsible for the UNIFI Scientific Information System software release for our new Bioanalysis Systems. Steve came to Waters in 2004 through the acquisition of NuGenesis Technologies where he was a Senior Product Manager for the NuGenesis SDMS platform from 1999-2000. From 1982 to 1999 he held technical and management positions at Shimadzu Scientific Instruments of Columbia, Md.. Steve has been involved in the development of software to support scientific research for over 20 years.
Sr. Manager, Global Compliance Services
Milford, MA, USA
Dana’s experience includes managing the structural validation of chromatography data systems, corporate quality system auditing, managing IT change control systems within both pharmaceutical and medical device production environments, as well as the definition and marketing of a range of quality/compliance-focused informatics solutions. In her present role, Dana has global responsibility for Waters’ compliance services and oversees a professional forum on the topic of computerized systems compliance (www.21CFRPart11.com).