从纸张到平台：人工智能驱动的质量管理体系演变

From Paper to Platform:The AI-Driven Evolution of MIKE KING, Senior Director, Product & Strategy, IQVIASANKARA NARAYANAN, Industry Director, Industrials, Frost & SullivanHANNAH SEEVARATNAM, Vice President, Quality and Regulatory, Robling Medical Table of contents Introduction and seven key takeaways1Introducing the five-step evolution of QMSs2Assessing adoption maturity3Identifying the role of AI in QA/RA4Moving beyond technology: people, culture, and change management5Demonstrating value and realizing ROI6Conclusion and final thoughts from our QMS experts7About IQVIA8About the authors9 Introduction As medical device and in vitro diagnostics companiesface increasingly complex regulatory demands, theneed for a smarter Quality Management System (QMS)is becoming more urgent than ever. Greater complexityrequires a more agile shifting from reactive execution to Seven key takeaways will be digital, connected, and — increasingly —infused with AI. hammer. Be strategic in your application of AI.3 An AI-infused QMS has the potential to elevateregulatory readiness, streamline documentation, andimprove risk management. However, organizationsmust avoid a scattergun approach to AI adoption.Similarly, a wholesale embrace technology is unlikely explain why new and unfamiliar workflows and technologies will ultimately accelerate timelines to better understand their needs and to align your delivery with outcomes that benefit the widerorganization. They will help QA/RA position the vast volumes of data, and augment its capabilitieswith human intelligence, insight, and experience Whether you are at the beginning of your digital QMSjourney, consolidating fragmented systems, or exploring problem statement. This allows you to focus onthose things that are beneficial and ensure you The following pages draw on the expertise of three QMSspecialists — one a current practitioner — representingseveral decades of hands-on experience. During IQVIA’srecent LinkedIn Live webinar — From Paper to Platform: to an end, driving the timely provision of safe andeffective patient solutions. Don’t confuse the two. Mike King:We would all love to work with a single,AI-enabled solution, but we don’t go from walkingten meters to running a marathon overnight. Thesejourneys need clear milestones and checkpoints. Introducing the five-stepevolution of QMSs The first step — a paper-based QMS — remains an optionfor some, as the survey results below demonstrate.Increasingly, however, companies are moving beyondpaper alone. Some are using a combination of paper- Hannah Seevaratnam:Paper-based systems are oftencumbersome and complex, making the maintenanceof logs and the validation of records, for example, very Others, having finally jettisoned paper, are left with anassortment of point solutions, few of which — if any —are connected. In the spirit of connectivity, others are Sankara Narayanan:Paper-based systems will notsuffice. Today’s more complex manufacturing demandsthat quality management also drives operational As the graphic demonstrates, technological advancementmust be accompanied by parallel cultural and The pace of change will vary from company to companyand is informed by a range of issues. Paradoxically,global regulatory complexity — notably, the verificationand validation this demands — acts as a brake on new Assessing adoption maturity In the run-up to IQVIA’s most recent LinkedIn Livewebinar, we asked QA/RA practitioners where they are According to the results, 14% of organizations continueto rely on a paper-based system, with minimal or nodigital footprint. By contrast, one in five are deployinga digital platform featuring advanced AI. In between, For others, costs or risk aversion might prove to bebarriers, at least in the short term. King:I grew up in a world that was powered by leverarch files. I then moved into digital point solutions, thena connected digital ecosystem, and now we’re looking We’re at a pivot point. How easy is it to make the jumpfrom paper to AI? To borrow a phrase, “it depends andit’s complicated.” It requires data, document and processharmonization. It also requires cultural harmonization, Narayanan:Over the next few years, I expect the shareof companies using digital platforms with advanced AI Seevaratnam:I find it astonishing that 14% of medicaldevice companies are still paper based given theadvance in electronic systems. At the same time, I’m While these middle two options reflect the state ofmaturity currently experienced by most organizations,it is the first and fourth options that provide morepoints of reflection. For some, 14% understates the 14% of organizations continueto rely on a paper-based system, King:There’s a phrase we use a lot in the UK: if you’vegot a hammer, everything looks like a nail. There’s alwaysa risk that in the context of current AI advancements, youpick up the magic hammer and start hitting everything. Identifying the role of AI AI could be the answer w