Medicine bottles in a row, labelled to meet FDA compliance standards

FDA 21 CFR Part 11 Compliance is a mandate requiring FDA-regulated industries (with some specific exceptions) to implement heightened controls for audit trails, electronic signatures, and documentation for software and systems. Keeping in line with compliance mandates is not always a simple task, especially when penalties for violating these guidelines can include fees or contract termination, which is why RACO is here to provide the equipment, software, and expertise needed to craft a Compliance Labeling solution tailored to the unique needs of your business — keeping your labeling and tracking processes safely up to code.


The RACO Barcode FDA Compliance Labeling solutions combine label design and printing technology with intuitive tracking software into a single regulatory solution that helps your organization keep within the bounds of FDA compliance standards. The solution allows its users to easily design labels and barcodes within the bounds of compliance guidelines, approve designs with electronic signature capture, and create custom document and log reports, ensuring that all security and traceability requirements are safely met. The solution can even allow you to manage many printers in multiple locations from a single server, conveniently expanding compliance to every part of your business.


From the planning stages all the way through integration into your workflow, our team of certified experts are here to guide you through every step toward attaining the ideal FDA Compliance Labeling solution for your specific needs. We also offer printer maintenance and repair services over the entire lifecycle of your labeling solution.

Contact RACO to see how our solutions can benefit your business.