Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
Computer systems validation (CSV) has long been a regulatory necessity but is considered time and resource-consuming to execute. Traditional Validation processes present challenges since they extend project timeline and costs, impacting time to market, resulting in an inability for life sciences organizations to promptly deploy newer versions of the software.
In this webinar, learn how the utilization of automation can transform the CSV process for your QMS:
- Utilization of automation within the framework of the CSV process
- How automation can be used to create the same required artifacts as manual execution, with increased accuracy and coverage
- How automation can accelerate the timeline for upgrades with a comprehensive suite of software solutions that streamline impact assessments and drive changes in validation scripts based on the outcome of those assessments
Massimo Franza
Massimo Franza is Sr. Director of Software Development for Quality and Compliance Solutions at IQVIA and is responsible for the overall development, testing and release of IQVIA's Enterprise Quality Management System, SmartSolve, including technical documentation and validation packs.
With over 25 years of experience in enterprise class software applications in Europe and US, Massimo has joined IQVIA in 2007, where, before taking the role of Director of Software Development, he managed the product development and the team responsible to build SmartStudio, the Low-code Development Quality and Compliance platform used to build the integrated modules that compose the SmartSolve suite.
Expert in agile practices, Massimo is certified in IT Project Management (ITCPM) and in CMMI for Continuous Process Improvement.
Anthony Hudson
Anthony Hudson has devoted his career to the delivery of best of breed quality systems and processes to support the life sciences industry. Anthony has over 25 years of experience covering electronic Quality Management Systems (eQMS), Program and Project Management, Quality System Auditing and Validation, solution design and solution sales. Anthony has served in several capacities in the regulated space including Director of Quality and Quality Systems. His experience brings a well-rounded customer and vendor perspective to successful quality system implementation and validation. Anthony currently leads the team of US Principals supporting eQMS sales and implementation for IQVIA’s QMS pillar.
Davor Milosevic
Davor Milosevic has extensive experience within the Quality Assurance function of the life sciences industry. Over the last 15 years, Davor has designed, implemented, and maintained various GxP, Quality Assurance (QA), and Quality Control (QC) programs, as well as compliance infrastructures, including documentation (SOP) systems and training programs, and has performed hundreds of internal and external audits. He has led and managed inspections by FDA, other regulatory agencies (AABB, AATB, ISO, etc.), and commercial partners. His ability to build trust and confidence in an organization’s quality management system has established his expertise in the Quality Assurance arena. Davor is currently the Quality Assurance Director of Safety, Regulatory, and Quality for IQVIA.
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