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How can the cloud help with data integrity and quality issues across your global supply chain?
All your data used to be close by — under your control — and easily monitored. Now, as you outsource more and more, your direct control on quality is weakened. By using a cloud based solution you can take back control. You can monitor your quality metrics in real time wherever they’re being generated and head off issues way before an FDA investigator even sets foot in your facility.
This has benefits across your organization. First, your metrics dashboard acts as the heartbeat of your company. Any murmurs and irregularities can be corrected immediately. And second, by being able to see what is going on in real time you’ll be able to dramatically reduce costs and minimize risk.
Regulators are encouraging industry to implement quality systems that improve product quality. The ‘Quality Metrics Data’ guidance explains how the FDA will utilize that data to help drive inspections, and ensure practices support continuous improvement and innovation across the supply chain. They make it clear that you — the brand owner’s quality control unit (QCU) — are in the best position to compile reports from all the suppliers and manufacturers in your supply chain for submission to the FDA.
Quality systems must transform to align with evolving regulations and support responsibilities for quality and compliance when outsourcing.
In this session, you will learn how to:
Register today and see how innovators are showing the industry that taking proactive approaches to quality can have significant business advantages.
Who Will Benefit
Vault Quality Strategy
Ashley is responsible for Vault Quality product strategy, customer engagement, and business development. She has nearly a decade of experience in the life sciences industry, with a focus on quality solutions. Before Veeva, Ashley was the Industry Solution Manager in the Product Management and Strategy team at Sparta Systems. While at Sparta, she led the pharmaceutical vertical market, managed strategic partner alliances, and identified long-term growth strategies.
Daniel R. Matlis is Founder and President of Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan has over 25 years of experience in the Industry spanning the entire value chain. He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.