Loftware Cloud Compliance

Loftware Cloud Compliance is the preferred choice for companies in highly regulated sectors such as pharmaceuticals, medical devices, biotechnology, and food production. This solution provides a fully validated cloud-based labeling platform, including document management, audit trails, and compliance with international regulations such as FDA 21 CFR Part 11, EU MDR, and GxP. The software includes standard features such as role-based access control, document version management, configurable approval workflows, and support for electronic records and electronic signatures. In addition, you have access to a 12-year print history, allowing you to visually retrieve and trace every printed label, ideal for audits and quality control!

The environment is pre-validated according to GAMP 5 and is continuously maintained with validated updates. Hosted in Microsoft Azure, with high availability, data segregation, and extensive access control.

Loftware Cloud Compliance is fully compatible with our ATP-series, ColorCube, Lassie2 Plus, and ICP-410 printers.

Main features of Loftware Cloud Compliance

• FDA 21 CFR Part 11 & EU MDR compliant labeling environment
• Validated according to GAMP 5 – including validation package (IQ/OQ/PQ)
• Label design via browser or Designer client
• Full audit trail, version control, and digital signatures
• Workflow module with approvals and revision routes
• Separate environments for design, testing, and production (DTAP)
• Integrable with ERP, MES, LIMS via REST API
• Hosted in Microsoft Azure, including redundancy, encryption, and compliance certifications