📢 Convergence 2023 – Register now!

Contact us

For Medical Device Small and Mid-sized Businesses

Loftware NiceLabel Cloud Compliance

NiceLabel Cloud Compliance is the world’s first public, validation-ready Cloud labeling solution. It is the simplest way to design and print labels in a regulated environment.


Everything you need to manage labeling in a regulated environment


Digitize and standardize label approval processes


Automate mass label changes and approvals without creating hundreds of label variations


Capture and trace every label printed in the past 12 years


Simplify compliance with FDA UDI, EU MDR, FDA 21 CFR Part 11 and EU GMP Annex 11 regulations


Ease validation with a validation-ready labeling solution


Easily scale a compliant labeling solution to multiple locations, factories or business partners

Digitize quality control

Use NiceLabel Cloud Compliance to digitize your entire approval process. You can also automate mass label changes and approvals without creating hundreds of label variations.

And you can test any changes before making them live in your production environment using the system’s three-tier environment: Development (DEV), Quality Assurance (QA) and Production (PROD).


Comply with regulatory requirements

NiceLabel Cloud Compliance is designed to comply with the major regulations impacting the life science industry, including EU MDR, FDA UDI, FDA 21 CFR Part 11 and EU GMP Annex 11.

It includes built-in role-based access, document versioning, configurable approval workflows, electronic records and electronic signatures (ERES).

You also get a 12-year print history, which enables you to visually track every label you’ve printed during that time.


Easily maintain a validated system

NiceLabel Cloud Compliance is a validation-ready labeling solution.

It comes with a validation acceleration pack, which simplifies the validation process. Our team can assist with IQ, OQ and PQ documentation as well. We also reduce the validation burden by only updating the software once a year. And when it’s time for the software release, we give you a three-month window before updating your production environment. 



Request a demo

See how NiceLabel Cloud Compliance can make it easier for you to maintain a validated, compliant labeling solution.