FDA-regulated organizations have a lot of challenges that can and should be turned into opportunities. Have you ever asked yourself if you have the necessary IT infrastructure that allows your business to identify opportunities for growth? Today, for organizations serving the Life Science industry, which includes highly competitive biotech, pharmaceutical, medical device, and other regulated industries, remaining compliant while optimizing your manufacturing process to meet the demand is a tough challenge. This article takes a look at three ways regulated organizations can improve consumer safety.
Investing in the right people, processes and technology can enable you to effectively sidestep some of the challenges while keeping you focused on the long-term goal.
So how can FDA regulated organizations use technology to manage the challenges in this complex and ever-changing environment?
With digital technology, real-time inventory visibility and tracking has never been easier, especially in highly regulated environments. In order to effectively preserve and protect the quality of your products, track material expiration dates through shelf life management. Retest management ensures you proactively monitor, retest and quarantine materials as appropriate. The Internet of Things (IoT) can be utilized in areas where temperature and humidity control are key. IoT sensors can alert you in real-time of any deviations – enabling you to correct any problems or take preventative measures and move inventory.
An increasingly fragmented global industry is forcing today’s manufacturers to focus on compliance initiatives to maintain a competitive edge. Therefore, these companies need a business system with end-to-end traceability – one that can track and trace materials and ingredients from supplier to consumer. They need a system that can increase product visibility, speed recall activities, and improve the accuracy of recalls (pulling all products subjected to the recall – and nothing more).
No More Pen and Paper
Managing production in an FDA regulated facility is extremely difficult to do effectively when managing processes with paper and clipboards. Moving these critical processes to digital tools can help you save scarce resources – time and money. Tools like digital audits, task lists, and quality checklists can be recorded and tracked, which will ensure your team performs tasks exactly when and where needed – and according to safety standards. Digital entries also make managers more accountable, confirming when and where tasks were conducted and completed.
Digital technologies continue to provide new opportunities to communicate and engage with customers while maintaining the highest quality and compliance standards. This data shared across your organization will maintain safety, optimize product quality, improve production efficiency and ultimately reduce operating costs. The technology is out there and FDA regulated organizations need it to achieve growth and profits.