How to navigate an uncertain future June 23, 2020 A digital roadmap is key to the agility today’s life sciences manufacturers need Life sciences manufacturers are facing extraordinary times. Astonishing levels of agility, scalability and flexibility have been required over the past several months. And these demands are likely to continue for the foreseeable future.It can be difficult to anticipate the quality and operational challenges you’ll face over the next month, let alone the next year. But one plan you can’t afford to abandon is your digital strategy. Why Digital Transformations Still Matter Digital transformation has been a quality buzzword for some time. Far from diverting resources to those efforts, now is the time to fortify your approach, especially where your quality management system (QMS) is concerned. A robust digital QMS is a necessary tool for safeguarding patient safety and product efficacy. But it can also contribute to greater efficiency, speed and responsiveness—capabilities you need more than ever.One of the greatest benefits of a digitally mature QMS is its ability to drive manufacturers toward proactive quality, which enables: Agile, integrated, scalable quality systems across your organizationPreparation for and adherence to regulatory and industry trendsPredictive analytics to power strategic decision-making Streamlined process and operations to optimize total cost of quality The Benefits of a Proactive Approach Proactive quality is more than a means to achieve compliance. It can help you gain real-time insight into operational efficiency and productivity. Life sciences manufacturers who take this stance are better prepared to meet the needs of today’s complex, shifting landscape.KPMG Global Strategy Group estimates that many manufacturers spend about 40 percent of quality resources on “reactive activities” such as corrective actions and complaint handling.1By shifting those resources to a proactive approach, powered by a digital QMS engine, you can gain or improve— Real-time analysis of data from your operations systems (LIMS, MES, ERP, CRM)Proactive resolution of process and product deviations and nonconformancesSignal detection to identify trends for effective root cause analysis According to a recent report by Deloitte Insights, life sciences manufacturers who embrace smart technology such as digital automation, IoT connectivity and flexible processes—all hallmarks of a cloud-based digitally mature QMS—could see up to a 90% reduction in the time required to release a new product to market.2 How to Start Your Digital Journey While a fully digital approach offers the most benefits, not every organization is ready to move full speed ahead. Fortunately, you have options.Your first step should be to identify your key challenges and opportunities. Next, consider your short- and mid-range goals—say, for the next 3 to 5 years. With these details and an understanding of the strategic goals and priorities of other stakeholders, you’re ready to determine which path is right for you.Whatever you do—do something. Gartner notes that failure to modernize creates a competitive disadvantage and limits your “ability to optimize existing processes or create new products with digital approaches.”3 Make Your Move Even a small step forward can reap big rewards. But it can be a difficult decision. That’s why we’ve put together a guidebook, Three Paths to Proactive Quality, to help TrackWise customers navigate the digital journey. 1Handor, Camal; Kapadia, Anuj; van den Heuvel, Roger; van Zijl, Frobert. “Quality 2030: Quality Inside.” 2019. KPMG International Cooperative. https://assets.kpmg/content/dam/kpmg/xx/pdf/2019/09/quality-2030-quality-inside.pdf. 2Reh, Greg. “2020 Global Life Sciences Outlook.” 2020. Deloitte Insights. https://documents.deloitte.com/insights/2020globallifesciencesoutlook. 3Gandhi, Animesh; Holmes, Brad; Shanler, Michael; Smith, Jeff. “Business Drivers of Technology Decisions for Life Science Organizations.” January 22, 2020. Gartner. https://www.gartner.com/en/documents/3979846/business-drivers-of-technology-decisions-for-life-scienc.
CASE STUDY ABF-Pharmazie’s Journey with TrackWise Quality, Document and Training Management Hear why ABF-Pharmazie selected TrackWise to manage their Quality, Document and Training Management. Learn more
CASE STUDY Philips Healthcare ‘Made the Impossible, Possible’ with the help of TrackWise Marvel at how Philips Healthcare 'Made the Impossible, Possible' with the help of TrackWise. Learn more
EBOOK Life Sciences Industry Insider: Product Quality Ever wonder how TrackWise can help IT leaders in Life Sciences drive greater operational efficiency? Learn More. Learn more
WHITE PAPER Turning Quality Review Processes into Insights & Efficiencies through Business Applications The life sciences industry is evolving fast—those who harness data and adapt to complex regulations will lead in quality, safety, and market growth. Learn more
INFOGRAPHIC Life Sciences Recalls: Causes, Implications, and the Path Forward What is driving product recalls in life sciences? Here’s a quick breakdown of the most common reasons across medical device, pharmaceuticals, and biologics. Learn more
BROCHURE TrackWise Recall Management Datasheet Empower Your Recall Strategy: Drive Efficiency, Compliance, and Patient Safety Learn more
WEBINAR Transforming Compliance into Performance- A New Approach to Quality Reviews This webinar explores how new innovative solutions can transform traditional quality management processes into a source of operational performance, leveraging a unified, intelligent data ecosystem. Learn more
CASE STUDY Voice of Customer: Rahul Songire – Senior General Manager, CQA, Zydus | Digital Transformation Journey with TrackWise QMS Discover insights from ahul Songire - Senior General Manager, CQA, Zydus, as he shares his experience with TrackWise and its vital role in data analytics, highlighting how it saves time and enhances efficiency. Learn more
CASE STUDY TrackWise Digital video testimonial from Barry Cook, VP of Quality Operations – McKesson "I use quality and simplification pretty much hand in hand. All of us as quality professionals, we have big problems to solve and lots of regulation to navigate." Learn more
CASE STUDY Olympus | Digital Transformation journey with TrackWise Quality Hear how Olympus is standardizing, simplifying, and harmonizing to be efficient and compliant globally, with Honeywell Life Sciences. Learn more
CASE STUDY Voice of Customer: Suruchi Sharma, Regional Quality Manager @ Abbott | Experience with TrackWise Quality "They understand what we need, and they come up with a solution to that." Learn more
CASE STUDY Voice of Customer: Jagdish Meghrajani, Senior Manager IT @ Zydus, | Digital Transformation Journey with TrackWise QMS "TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites." Learn more
CASE STUDY bioMérieux | Quality Transformation journey Leading global diagnostics company, bioMérieux, started with TrackWise QMS and later transitioned to adopt TrackWise Digital. Hear more about their digital transformation journey and how our solutions foster trust, collaboration, and innovation in life sciences. Learn more
INFOGRAPHIC Automate and Visualize Batch Production | Elevate Efficiency and Quality TrackWise Experion Batch empowers Life Sciences manufacturers with advanced visualization, real-time data integration, and distributed batch control. Optimize productivity, ensure compliance, and maintain product quality with proactive decision-making and real-time alerts. Learn more