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 7th Annual European Medical Device & Diagnostic Quality Assurance and Regulatory Affairs Conference Unlock tomorrow's standards today: Innovate, collaborate, and lead at the Quality Assurance and Regulatory Affairs Conference! 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. Distinguished speakers will discuss cutting-edge strategies and procedures for meeting regulatory SQM & QMS requirements, implementing risk-based approaches, minimizing the risk of quality failures, and linking QA QC processes throughout the product life cycle. This two-day in-person conference will provide attendees with live content and highly interactive sessions supported by real-life business examples, case studies, Q&A sessions, panel debates, and interactive workshops. You’ll be able to network with your peers, including leading technology innovators and service providers, while exchanging ideas with the experts in a collaborative setting. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
WEBINAR Discover How Gedeon Richter Transformed Their Quality Management Hear how leading European Pharmaceutical and Biotech company Gedeon Richter successfully implemented a digital quality management system to support their business goals and patient-centric mission. Learn more
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. Learn more
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT Pharma Manufacturing World Summit Join us at Pharma Manufacturing World Summit on May 14, 2024 where Honeywell's Zillery Fortner will be co-presenting on "The Value of a Unified Life Sciences Solution in Pharma 4.0." Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
EVENT RQA 2024: International QA Conference With diverse industry representation including regulatory authorities like the MHRA, it’s a hotspot for those in GCP, GLP, GMP, pharmacovigilance, and more. The conference has evolved to cover a wider scope, offering unparalleled networking opportunities across three dynamic days for delegates, sponsors, and exhibitors to engage on pivotal industry topics. Register to attend this insightful event where you can hear our Industry Business Development Director, Fabrizio Mangilio deliver one of this year's RQA 2024 keynote sessions. We are Platinum Sponsors of the RQA 2024: International QA Conference Learn more
EBOOK 5 Things to Know About EUDAMED EUDAMED (European database for medical devices) is a centralized database that aims to enhance the transparency and traceability of medical devices in the EU. Learn more
WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
WHITE PAPER Future-Proofing a Pharma Manufacturing Legacy through Digital Quality Transformation As industries adopt technological advances and rapidly move into the fourth industrial revolution, it is essential to assess the impact of these isolated data pockets on the workforce, customers and the safety of patients. Learn more
WEBINAR Transforming Quality Operations in the Digital Age Learn how Orion is using TrackWise Digital® to transform quality operations and enhance traceability among suppliers to continuously improve quality and patient safety. Learn more
ON-DEMAND Quality Risk Management for the Pharmaceutical Industry An Introduction to TrackWise Digital® Quality Risk Management (QRM) for the Pharmaceutical Industry. Learn more
CASE STUDY Simplicity at the Forefront: Meitheal Pharmaceuticals Case Study Meitheal Pharmaceuticals Transforms Document and Training Management with TrackWise Digital® 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