Our product specialists examine the latest trends in quality management systems, that will make your job easier in 2016 and beyond
In 2015, regulatory compliance continued to cause headaches for quality managers. Driven in part by the pace of technological change, the growing body of standards, regulations and legislation governing life science industries continues to provoke anxiety in the quality community.
Safeguarding quality across the enterprise is never going to be easy, especially in a constrained economic climate. This year, the post-downturn mantra “doing more with the same” remained obstinately in place in the Life Sciences as elsewhere, and resource limitations combined with internal processes and supply chain complexities present the risk of a perfect storm in 2016.
So how are emerging technology trends helping quality managers to identify the weak links and disjointed workflows that can easily compromise compliance?
There is a growing recognition among Life Science quality professionals of available Quality Management Systems (QMS) that can pull suppliers closer together, streamline quality activities and make global supply chains less fragmented. Many of these new capabilities are enabled by cloud services, omni-channel approaches and data analytics.
The cloud is now a mainstream asset across all industries. The indirect benefits for quality managers – which include process visibility and ease of system integration across the supply chain – will continue to manifest themselves as new enhancements to quality management cloud-based platforms.
The value of subscription-based models and minimal on-premises infrastructure is also becoming clearly understood, and case studies are coming on stream that alleviate security concerns. We predict that life science organizations that have relied on manual processes can now leapfrog straight to these new cloud-based quality management platforms.
Omni-channel communications, enabled by the ubiquity of mobile technologies, give stakeholders across the supply chain real flexibility, with instant communications and system access from any location, minimizing error and data loss. So we should see omni-channel moving up the quality agenda in 2016 as more mobile innovations come on stream.
“While devices are increasingly connected to back-end systems through various networks, they have often operated in isolation from one another. As the device mesh evolves, we expect connection models to expand and greater cooperative interaction between devices to emerge.”
Data analytics present a detailed audit trail of activities and assets across the enterprise and beyond, underpinned by system integration. These are a valuable aid to the quality manager. In 2016, more and more business decision-makers will get to grips with the intricacies of big data – a process that is already happening – and savvy quality managers should prepare to respond to this with a deeper understanding of the benefits that data visibility delivers in terms of compliance, as well as the role predictive analytics can play in risk management.
Quality management system vendors will develop their analytical capabilities further, with dashboards and other tools that make it easier for quality professionals to navigate and interrogate the mass of operational data today’s life science organizations are sitting on. Data analytics will ease the challenges of tracking compliance across the enterprise and supply chain.
“According to Gartner, by 2020, 25 billion devices will be generating data about almost every topic imaginable. This is equal parts opportunity and challenge. There will be a plethora of data, but making sense of it will be the trick. Those companies that harness the power of this tidal wave of information will leapfrog competitors in the process.”
Internet of Things
Connecting operational devices and platforms means real-time communication across multiple locations, and that has the potential to deliver significant time and cost efficiencies. But crucially, from a quality perspective, it can eliminate the human errors that can creep in with suboptimal systems and processes.
“Everything in the digital mesh produces, uses and transmits information. This information goes beyond textual, audio and video information to include sensory and contextual information. Information of everything addresses this influx with strategies and technologies to link data from all these different data sources. Information has always existed everywhere but has often been isolated, incomplete, unavailable or unintelligible. Advances in semantic tools such as graph databases as well as other emerging data classification and information analysis techniques will bring meaning to the often chaotic deluge of information.”
The Future of Quality Management Systems
So when we consider emerging trends such as the Internet of Things (IoT) in conjunction with consolidating developments including the cloud and data analytics, we get a tantalizing picture of transformed reliability and visibility across the enterprise and supply chain. The benefits of all trends working in unison is going to be so much greater than the sum of the individual parts.
Long and complex supply chains, along with an ever-changing regulatory landscape, present big compliance challenges.
The cloud has moved into mainstream business adoption as the value of subscription-based models and minimal on-premises infrastructure become clearly understood.
Omni-channel will move up the agenda in 2016 as quality professionals recognize the operational benefits of mobile technologies.
Business leaders are finally getting to grips with data analytics, and quality managers should be prepared to respond to this with meaningful uses of big data in their field.
The Internet of Things can play a transformational role in eliminating the human errors that can creep in with suboptimal systems and processes.