January 3, 2024
As manufacturers face increased pressure to optimize their quality management processes, EQMS solutions providers are leveraging advanced technologies to meet these demands.
Here are three of the top 2024 technology trends supporting manufacturer EQMS optimization and regulatory compliance. They closely align with the FDA’s digital transformation journey, as described in the agency’s Information Technology Strategy for Fiscal Years 2024-2027.
1. Process and data digitization
The complexity of manufacturing and quality management today exceeds the capacity of manual, paper-based processes. The level of sophistication required to identify and address quality issues throughout an ever-expanding enterprise necessitates visibility that can’t be found in spreadsheets or PDF files.
Automating and integrating quality processes, data, and documentation through an electronic EQMS is a manufacturer’s first step to achieving the benefits of digital transformation – greater efficiency and lower costs. It minimizes manual intervention, dramatically reducing staff hours dedicated to routine tasks, and makes it easier for quality teams to find the information and documents they need when responding to auditor and regulator requests.
2. Cloud technologies
The next step on the quality management transformation journey is the transition to cloud based EQMS. In her recent article, Forrester Linda VP, Research Director Ivy-Rosser noted how “organizations are now placing a critical focus on enterprise software’s main challenges.” This is driving enterprise software manufacturers to increasingly transition from on premise platforms (ERP, SCM, CRM and HCM) to software as a service (SaaS).
Implementation of a cloud based EQMS alongside other key enterprise SaaS solutions opens the door to a level of quality process optimization impossible with on premise systems. System and data integration are effortless. Quality teams have real-time access to comprehensive insights throughout the end-to-end value chain, from R&D to manufacturing to supply chain. Manufacturers can effortlessly scale quality and compliance processes as they grow.
3. Artificial intelligence
Artificial intelligence (AI), in its many forms, will be the most important area of technology in 2024, according to the findings of The Impact of Technology in 2024 and Beyond: an IEEE Global Study. AI tops most analysts’ lists for 2024 technology trends. This includes predictive and generative AI, machine learning (ML) and natural language processing (NLP).
Manufacturers that have implemented a cloud based EQMS to establish a source of real-time, accurate and complete quality data are positioned to leveraged AI-enabled actionable analytics to drive data-driven quality improvements. The speed at which AI can analyze tremendous volumes of data far exceeds the ability of any human. Instead of quality teams searching for insights and answers to their questions, AI presents this information to them.
With AI-driven analytics, quality management teams can act rapidly with precision – identify anomalies, patterns, and trends (descriptive analytics); find the root causes of problems (diagnostic analytics) and make predictions about future quality events (predictive analytics).
Conclusion
Manufacturers that leverage advanced technologies to improve quality oversight and management throughout their operations – from research and development (R&D) through to post-market practices – can successfully navigate market challenges and identify and address risks before they result in costly quality and compliance failures.
Having an exceptional level of quality control allows companies to pivot rapidly to mitigate risks, drive efficiency in their development and manufacturing processes, maintain compliance, and deliver high-quality products to market with speed and cost effectiveness.
To learn more about the benefits of automating your quality processes and digitalizing your data, read this whitepaper: Bridging the Quality Management Digital Divide.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
