How to navigate an uncertain future

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 organization
• Preparation for and adherence to regulatory and industry trends
• Predictive 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 nonconformances
• Signal 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.

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.

1. Handor, 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.

2. Reh, Greg. “2020 Global Life Sciences Outlook.” 2020. Deloitte Insights. https://documents.deloitte.com/insights/2020globallifesciencesoutlook.

3. Gandhi, 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.