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Products overview

Develop UDI-compliant labeling process

Our solutions are purpose-designed to address the specific challenges encountered in medical device labeling, including compliance with the FDA’s Unique Device Identification (UDI) system, to enable traceability from manufacturing through distribution to patient use.

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Key steps to compliance

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Integrate with sources of truth

Best practice for managing UDI and other labeling regulations is to source data from approved content, trusted ERPs and other applications that generate serial numbers required for UDI.

Regulations

Rapid response to regulatory labeling demands

Be agile with changing regional and international regulatory requirements for labeling, including those mandated by the FDA's UDI Systems

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Accurate Reporting

Ensure auditability with eSignature and business intelligence that allows you to review, analyze and report on all activities so you can safely meet regulations

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Enable data-driven labeling

It’s important to have dynamic labeling that enables users to manage a single template for a range of variations to support increasing complex requirements and speed up the validation process

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Centralize your data

Your business may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized labeling brings visibility and control – and the ability to demonstrate compliance.

business-processes

Re-think legacy systems

Spreadsheets, legacy systems and even some labeling software packages are not secure. You need an automated, validated solution that can easily accommodate new requirements and safeguard against future regulations.

Keep pace with FDA UDI, EU MDR and 21 CFR Part 11 regulations

Loftware Labeling Solutions helps medical device companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance. 

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Stay UDI-compliant with Loftware

Our Labeling Solutions enable you to comply with FDA UDI, EU MDR and 21 Part 11 regulations quickly and easily. Loftware offers validation-ready solutions for both on-premise and cloud environments. With Loftware, you can keep pace with the latest regulations, and quickly deploy a compliant labeling process globally.