The three pillars of the Life Sciences industry May 7, 2020 Elevating the role of the technology solution provider in service of the health and wellness of the global population The Dilemma for Quality LeadersQuality Management System (QMS) process complexity and variability is an industry-wide, systematic problem that brings a heavy burden of cost and risk. The pace of innovation and disruptive nature of novel product are equally both exciting and challenging from a quality enablement perspective.The patient is becoming the center of the universe that the life sciences supply chain serves. The line separating that supply chain from the broader healthcare ecosystem blurs through this growing trend of patient-centricity.That same supply chain becomes ever more complex as it is increasingly virtualized and outsourced. Simultaneously, the volume of acquisition and divestiture in the space continue to rise.Much of this is driven by the reality that is Industry 4.0. This makes even measuring total cost of quality (TCoQ), let alone controlling or decreasing it, a far important and difficult endeavor. These macro trends sum up well, Mode 2 of the bi-modal challenge faced by industry today as it pulls in opposition to the day-to-day micro challenges of Mode 1.And if this outlines Mode 2, Mode 1 can be well characterized by the five key imperatives front and center in the minds every quality leader on a daily basis: Product qualityProduct efficacyPatient safetyContinuity of supplyCompliance And so, while that quality leader is buried under existing and growing pressures – complex change controls, customer complaints in the thousands, product recalls, inspections in multiple manufacturing sites at any given time – now they have the head of R&D asking for unique quality system capabilities to support of novel product and the head of engineering needs a quality system innovation for the digital ‘factory of the future’ that was recently approved. Technology’s Place as the Third PillarTraditionally, the manufacturer of medical product has partnered with the regulator to solve for the future-facing challenges the life sciences industry has faced in the realm of quality and compliance.Often, these two pillars of industry – manufacturing and regulation – would engage expert consulting firms in this endeavor with great success, but also at great expense. The technology solution provider would then be asked only to deliver the enabler of the defined solution, having had little involvement in the ideation.Thanks in part to the rise of the fourth industrial revolution, that is about to change. Now, the technology solution provider has a far better seat at the table.Historically, in the discipline of quality management systems, rarely would a medical products manufacturer look to their QMS provider for deep, strategic, and disruptive innovation that would deliver a significant business transformation.Industry 4.0 has brought into view such disruptive technologies as artificial intelligence (AI) and the Internet of Things (IoT), amongst others.Harnessing the power of these innovations has elevated and accelerated the ability to facilitate, to catalyze, to unleash the full potential of the novel products, treatments, and therapeutic services the manufacturers are bringing to the market.It is imperative that technology providers’ relationships with regulators are elevated so that the role, the accountability, the value is recognized and championed by them as much as it needs to be by the manufacturers.These three pillars of this industry have an ethical obligation to use the innovations afforded to us in the service of public health. Only together in selfless and passionate collaboration, can we ultimately uphold the future health and wellness of the global population.Sparta Systems shares insights about macro and micro industry trends that affect quality in such a bi-modal manner. 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
EVENT TUG Americas Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Learn more
EVENT Building a Winning Life Science Eco-system – Leveraging the Quality Link between Platform, Processes and Patients Watch this unique webinar to discover how Life Science organizations can a combine a best-in-class platform with freedom of solution choice to improve product quality, productivity, and supply chain continuity. Learn more
CASE STUDY Empowering Innovation: Revelle Aesthetics Transforms Document Management and Training with TrackWise Digital Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management. Learn more
BLOG The Impact of Digital QMS Solutions on the Life Sciences Industry The evolution of cloud-based quality management systems is transforming expectations and changing realities in the life sciences industry. Find out how in our latest newsletter edition. Learn more
BLOG Integrated Risk Management: Go Beyond Compliance To ensure patient safety, proactively detect signals and trends and continuously improve device quality and safety, integrating quality risk management with the quality management system (QMS) is essential. In our latest article, we consider the benefits of this integration and address the growing complexity of risk management. Learn more
BLOG Cultivate a Culture of Quality: 3 Steps to Getting Started Cultivating a quality culture is critical for any organization's long-term success, regardless of industry or size. Learn more
BLOG How Pharmaceutical Quality Drives Performance While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still find mid-size or emerging manufacturers manually entering data into spreadsheets or using siloed systems that are unable to share information electronically. Learn more
BLOG CAPA Management: Technology to the Rescue If you have been struggling with corrective and preventive action (CAPA) management, it’s possible there is a tech solution that will lift the burden. Learn more
BLOG The Power of Integration: A Holistic Approach to Quality and Document Management One of the key components for Life Sciences companies is to have their documents and data in order.... Learn more
BLOG It’s Time For The Life Sciences Industry To Embrace Quality 4.0 Sparta’s President and CEO, Oxana Karpenko Pickeral, explores how the Life Sciences industry can address core challenges and connect the “data dots” by embracing Quality 4.0. Learn more
WHITE PAPER How Digital Technology Accelerates Your Move to Proactive Quality Leading manufacturers are embracing digitization initiatives to stay competitive in the global economy. Are you one of them? Learn more
EVENT Harmonizing Quality and Manufacturing Excellence through Digitization and to Support Pharma 4.0 Presented by Sparta’s Max Ma, Industry and Business Development Director, and George Peters, Sr. Offering Manager, Life Sciences at Honeywell Process Solutions, exploring how to harmonize quality and manufacturing excellence through digitization to support Pharma 4.0. Hosted by Xtalks. Learn more
CASE STUDY Eisai’s TrackWise Digital Conversion: From On-Premises to the Cloud The company continues to automate key quality processes since conversion to TrackWise Digital. Learn more