Can your QMS help you weather the current crisis? April 21, 2020 Mature solutions can ease exceptional change With the unprecedented challenges that manufacturers are facing during the COVID-19 pandemic, quality management might be the last thing on your mind. But your quality management system (QMS) could be one of your best means of meeting today’s needs for greater scalability, streamlined document-management workflows, and extended visibility across enterprise sites and supply chains. After all, quality is about more than compliance; it’s about consistency, productivity, and reliability. And those are all vital components to weathering any unpredictable, fast-changing environment—be it brought on by a merger, technological disruption, or global health crisis. The key is to ensure that your QMS is up to the task Even some software based QMS solutions lack the flexibility and robustness to support the scalability and insight that are needed in times of growth or crisis. But a digitally mature QMS can provide functionality to help you meet multiple needs. Easily scale quality operations to meet increasing market and supply chain demands Improve operational efficiency by streamlining your document management process Ensure product quality standards throughout your extended supplier network Reduce resolution time and accelerate time-to-market through proactive analysis of quality events However, there are a range of digital capabilities available on the market. Most solutions have evolved and advanced to different stages. On the low end, a QMS might feature only the most rudimentary digital functionality; on the high end, a supremely sophisticated solution can enable a proactive, predictive quality stance. Where does your current quality approach fall along this spectrum? Ad-Hoc At the low end of the digital capabilities, quality management is fragmented, involving mostly manual or even paper-based processes. Email communication is about as digital as things get at this level. The downsides of such systems are clearer than ever. Manual quality management doesn’t hold up well when production personnel lack sufficient time and focus to take accurate recordings and then translate them from paper to electronic records. The organization lacks extensive, comprehensive access to the quality data it needs to make proactive, actionable business decisions. And forget about gaining any predictive insight from a piecemeal, document-centric system. Managed Organizations that can capture quality data electronically—say, in an Excel spreadsheet—fare slightly better. These manufacturers might maintain a digital list of approved suppliers, supplier agreements, or even supplier ratings. However, they don’t have a dedicated, software-based QMS that can help them gain the insight they need to increase efficiencies. Automated These days, many manufacturers—especially those in the life sciences field—have some level of quality automation. Such organizations likely have an on-premise QMS, although larger companies with multiple manufacturing sites might use different QMS versions or even different products. (This is especially true in the wake of mergers or acquisitions.) The QMS meets regulatory governance requirements and might even extend to Tier 1 suppliers. But although quality data is electronically accessible, visibility is limited, and turning that data into the type of analyses that leads to proactive decision-making is a chore. Connected Connected organizations understand the benefits of the cloud. They likely look for a QMS that is available in SaaS form (or a hybrid option), offers automation, and integrates with other automated solutions, such as ERP systems or supplier systems. A QMS at this level offers reporting and analytics that supports business decisions. Proactive At the top of the digital maturity scale, best-in-class QMS options leverage the latest technology—and help manufacturers future-proof their investments. QMS software is cloud-based, ready to handle the massive amounts of data that the IoT produces and might even incorporate the benefits of emerging technology like artificial intelligence, machine learning, and natural language processing. At this level, quality becomes not a chore but a cultural value. Compliance is a benefit but not the only end goal of quality data, which provides predictive insights that enable optimal outcomes for both the organization and its customers. Is Your QMS Helping You…or Holding You Back? Wondering how your QMS stacks up? The quality experts at Sparta Systems have put together a digital maturity checklist. Use it to see where your current solution fits—and where you might need additional support. Share via: Twitter LinkedIn Facebook Email
EVENT 9th GCC Regulatory Affairs Pharma Summit (and Quality Conference) 2024 GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. We are Gold Sponsors of the 9th GCC Regulatory Affairs Pharma Summit 2024. Learn more
EVENT 7th Annual European Medical Device QA & SQM Conference 2024 The 7th Annual European Medical Device and Diagnostic Supplier Quality Management Conference aims to bring together the industry’s top-performing Supplier Quality Management (SQM) & QA QC professionals under one roof. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
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