Loftware Cloud Compliance
The first validation-ready Cloud Solution for Labeling
Loftware Cloud Compliance is a groundbreaking, world-first, fully validation-ready public cloud solution that enables easy label design and printing in regulated environments.
Regulatory Compliance
The system is designed to meet key regulatory requirements in the life sciences industry, including EU MDR, FDA UDI, FDA 21 CFR Part 11, and EU GMP Annex 11. Features include role-based access management, document versioning, adaptive approval workflows, electronic documentation, and electronic signatures (ERES).
In addition, the system provides a 12-year print history, allowing visual tracking of every label printed during that period.
Easy maintenance of the system after validation
Loftware Cloud Compliance streamlines the validation process thanks to its out-of-the-box nature, which can be further supported by the Validation Acceleration Pack (VAP). If necessary, our team offers support in creating IQ, OQ and PQ documentation. The system requires only one update per year, which significantly reduces the effort associated with maintaining compliance. Once a new software version is implemented, users have three months to adapt their production environment to the latest version.
Material developed in cooperation with GS1 – an official agency accredited by the FDA and the EC, responsible for issuing UDI identifiers and implementing UDI standards in our country.
