Loftware NiceLabel Cloud Compliance Oracle Integration Bundle [1 Printer, 1 Year]

Digitize Quality Control

Digitize your complete approval process with Loftware Cloud Compliance. Streamline mass label alterations and approvals effortlessly, eliminating the need for numerous label variations. Furthermore, leverage the system's three-tier environment—Development (DEV), Quality Assurance (QA), and Production (PROD)—to test any modifications before implementing them live in your production environment.

Comply with Regulatory Requirements

Loftware Cloud Compliance is crafted to meet the significant regulations that affect the life science sector, such as EU MDR, FDA UDI, FDA 21 CFR Part 11, and EU GMP Annex 11. It incorporates built-in role-based access, document versioning, customizable approval workflows, electronic records, and electronic signatures (ERES). Additionally, it provides a 12-year print history feature, allowing you to visually monitor every label printed within that timeframe.

Easily Maintain a Validated System

Loftware Cloud Compliance is a labeling solution ready for validation. It's tailored to simplify the validation process, complemented by the Validation Acceleration Pack (VAP) option. Our team is available to support with IQ, OQ, and PQ documentation. Additionally, we minimize the validation workload by updating the software annually. When it's time for a software release, we offer a three-month window before updating your production 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