Complying with the 21 CFR Part 11 rule

by Jessica Plourde Hutter, on February 12, 2016

21 CFR Part 11 labelsIn an increasingly complex market for pharmaceutical drugs and medical devices, manufacturers are relying on electronic systems to produce, store, ship and track their products. In particular, extensive barcode labeling systems are crucial for ensuring a reliable, accurate and traceable supply chain.

But these systems must have the capacity to keep up with the Food and Drug Administration's regulations regarding electronic records management. The FDA labeling regulation and the 21 CFR Part 11 rule requires that drug and medical device manufacturers preserve records of all the systems that are used in the production process. This includes barcode labels. Proper medical device labeling is necessary to ship products throughout the supply chain, while maintaining adequate tracking standards for better safety and efficiency.

Specifically, 21 CFR Part 11 requires that electronic records be auditible, so that any problems are easy to track to the source. It's important for manufacturers seeking to comply with this regulation to use an Enterprise Labeling Solution that has this capability. 

For instance, Loftware Spectrum 2.7, a 100 percent browser-based labeling solution allows customers to meet complex labeling requirements while providing unprecedented levels of visibility and control. Our system can integrate seamlessly with an existing business process while helping users configure their workflow to meet their unique needs. This is perfectly suited for the regulatory environment created by 21 CFR Part 11. 

In the coming years, the FDA's labeling regulations will continue to evolve as they update its labeling regulations to meet the demands of a 21st century. In the interest of FDA compliance, as well as transparency and traceability, it is important for manufacturers to invest in better enterprise labeling solutions.

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Topics:Medical Devices