On January 26-28, I had the opportunity to attend the Oracle Value Chain Summit (VCS) in San Jose, CA. The theme of the event was “Enabling Agents of Change.” Over 2,500 Value Chain experts representing more than 425 companies from 31 countries attended this year's VCS, and the attendees had the chance to hear from thought leaders, practitioners, and executives on a range of business and technology topics across engineering, product development, manufacturing, maintenance, quality management, and more.
Audit management is an area where enterprise quality management software (EQMS) has a solid history in harmonizing direct and indirect processes, and providing a strong ROI. Some might argue that audit management should take priority over other processes given that it has a correlation with performance, something we will discuss below.
The impact of training management is often overlooked by executives, despite its grave importance and close connection to compliance, quality, health, safety, and a wide variety of other key areas related to business performance. Fortunately, automation, combined with other next-generation software capabilities has transformed training management into a tool that’s more useful than ever.
Quality professionals recognize that conformance and harmonization of an enterprise Quality Management System (QMS) begins with a solid document management foundation. But the reality is, most organizations are drowning in documentation—which is why there’s no surprise that document management remains at the very top of quality management processes that have been automated by organizations.
Many topics in 2014 have wrestled for the attention of quality management executives. These range from understanding and planning for the potential quality intelligence yield of smart connected products to the maturation of cloud-based enterprise quality management software (EQMS).
On November 13, LNS Research and FDA News hosted a webcast entitled, "A Roadmap for Addressing Quality and Manufacturing Challenges in Life Sciences: Moving Beyond Regulatory Burdens to Enable New Collaborative Models for Growth." As usual, we received more questions during the course of the event than we had time to answer live. In this post, I'll answer some of the top questions that went unaddressed due to time constraints.
In a previous article we discussed findings from a recent LNS survey and revealed that 43% of manufacturing professionals don’t understand the IoT. A concerning, but not surprising result. There’s something important lurking behind the fact that most have heard of the ubiquitous term–it is hard not to have. And yet minimal understanding by a significant number of quality executives persists and therefore there’s less active pursuit of the potential fruit it yields, other than by innovators, for now at least.
Life Sciences is an industry driven by innovation and growth. What lies beneath those two drivers is a world of complexity across the drug or device lifecycle. It’s clear that those companies that can continuously and collaboratively ensure quality, meet regulatory compliance, and mitigate risks in each stage of the lifecycle have a competitive advantage, but what’s needed to do so?
If you’re in the life sciences industry, there’s a good chance you're in a tight operational spot. In life sciences, there are some notable trends—some immediate, some distant and slow moving, but very real and inevitable—that are coming together to place new and unheard-of strains on both quality and manufacturing operations.
Quality management maturity is, no doubt, a journey. If you speak with executives from some of today’s most successful companies, you’ll hear a number of similarities about this topic. Whether in regard to skill development, business processes, technology, performance management, or something entirely different, early on, decisions tend to be made reactively, almost always to fix a problem. But as maturity progresses, decisions gradually start being made with proactivity and, ultimately, predictability in mind.