A Prescription for Digital Traceability
by George Jewell, on Jan 7, 2020 3:19:07 PM
Sophisticated new track-and-trace solutions can be an essential tool for medical manufacturers
In recent years, the emergence of sophisticated new track-and-trace tools and technologies has given manufacturers powerful new capabilities. Leading systems and solutions like the eFlex Track & Trace platform make it possible to store, retrieve, and report part status in the production environment. Deployed strategically, these systems can enhance efficiency, reduce waste, and lower costs—all while moving closer to the ultimate goal of greater quality and consistency.
Virtually every manufacturer can benefit from the advanced monitoring and tracking that these platforms provide. But for medical manufacturers in particular, the introduction of these new tools is a potential game-changer. From drug-makers to medical device manufacturers, medical manufacturing comes with some of the industry’s most rigorous and complex compliance standards.
Medical Manufacturing Regulatory Framework
The regulatory framework surrounding medical manufacturing is created and enforced by the FDA as part of its mission to ensure that medical devices available in the United States are safe and effective. While enforcement is a key part of that mission, the FDA has extensive proactive programs in place to promote quality design and manufacturing practices. Initiatives like the Case for Quality allow the FDA to identify device manufacturers that consistently produce high-quality devices, as well as “identify and promote practices that support consistent quality manufacturing,” and align “regulatory, enforcement, compliance approaches with those practices. The FDA also participates in the Medical Device Single Audit Program (MDSAP) as a complement to regular agency inspections.
Manufacturers also have to be cognizant of Current Good Manufacturing Practice (CGMP) regulations, Electronic Device History Records (eDHR), which make it easier to collect and store FDA-required records, and other relevant, required, or simply helpful manufacturing regulatory systems and standards.
True Digital Traceability and Product Genealogy
Given the complexity of these regulatory standards and practices—and the potentially significant consequences of non-compliance—it’s easy to understand why new tools that allow medical manufacturers to not only seamlessly and automatically comply with those guidelines, but to do so in a manner that provides part-specific precision and verifiable documentation, are so appealing.
Proven systems and solutions that deliver true digital traceability and product genealogy not only make it possible for medical manufacturers to fulfill government requirements, but the ability of flexible new platforms to connect directly to eDHR tools and other manufacturing regulatory systems ensures that compliance can be achieved in a manner that is minimally disruptive and compatible with existing infrastructure.
Meeting Evolving Expectations
Today’s leading track-and-trace manufacturing solutions come with a wide range of potential benefits for medical device manufacturer: meeting the evolving expectations from consumers and demand from professional partners; protecting brand integrity and manufacturer reputation; and minimizing or eliminating downstream liability exposures are all incredibly valuable advantages. But making it possible to achieve comprehensive and fully documented regulatory compliance in an industry where regulatory oversight is so critical is a profound and potentially defining difference-maker.