The Industry’s Most Powerful Enterprise Labeling Solution for the Medical Device Industry
Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device manufacturers of all sizes to meet rigorous regulatory requirements as they seamlessly implement, deploy, maintain and scale their labeling operations globally. Preconfigured capabilities unique to the medical device industry speed your implementation and dramatically improve your labeling processing. Spectrum for Medical Device enables compliance with UDI, EU MDR and 21 CFR Part 11 regulations and supports validated environments, providing audit tracking and security controls combined with workflow management and eSignature capabilities. Available in the cloud or on-premise, Spectrum for Medical Device provides a comprehensive digital platform offering unrivaled performance and ensures accuracy, consistency and compliance.
Fast and Efficient Label Design
Spectrum for Medical Device offers new levels of collaboration and ensures unprecedented control and consistency over label design. Sample GS1-ready label templates and a comprehensive set of commonly used symbols streamline your label design process and help you comply with industry regulations. Business users can easily create and update labels with Spectrum’s easy-to-use, browser-based WYSIWYG design capabilities, freeing up scarce and costly IT resources.
Advanced Workflow to Streamline Review and Approval
Automate and streamline processes throughout your organization, enabling stakeholders to gain access and manage labeling smarter, faster and more efficiently while ensuring a complete audit trail of users’ actions. Spectrum for Medical Device’s configurable workflow framework and eSignature capabilities offer new levels of visibility, full audit tracking and powerful control for managing labels. You can define and manage approvals and workflow processes to eliminate bottlenecks, improve accuracy and ensure compliance.
Certified Integration to Leading Enterprise Applications
Leverage existing business processes and vital data sources to drive labeling using Spectrum for Medical Device’s powerful integration capabilities. You can connect with any of your existing business applications to automate and streamline labeling processes. This includes pre-built certified SAP and Oracle integrations, as well as flexible web services to communicate with any source of data and/or application.
Dynamic, Data-Driven Labeling to Meet Evolving Demands
Spectrum for Medical Device’s data driven labels dramatically reduce the quantity of labels needed to support your labeling solution, reducing the time spent on label design and maintenance. Spectrum’s business logic supports this effort by allowing you to dynamically select additional external data based on any combination of data in the print request, user information, location, or any other factor available.
Streamlined Content Management for Improved Efficiencies
Spectrum for Medical Device simplifies the label design and approval processes by providing access to robust content and digital asset management functionality which support version control required in validated environments. Spectrum creates time and cost efficiencies and enables comprehensive audit tracking while increasing label consistency by letting you build a library of pre-approved content available for use across a global enterprise.
Empower Users to Create Custom Applications
Spectrum for Medical Device includes six pre-built applications to manage common labeling processes required in the Medical Device Industry. Applications can drive decisions based on input from users and provide a “wizard” -- complete with eSignature requirements -- guiding users down the appropriate path, removing any guesswork or potential for human error. The pre-configured applications include label preparation, sample print, label print, post-processing, summary reporting and historic reprint, enabling compliance with 21 CFR Part 11. You can copy or modify existing applications or create new applications for labeling and other business processes. Spectrum’s drag-and-drop user interface makes the development and maintenance of applications (often used for on demand printing) dramatically faster and easier.
Printing with Unrivaled Performance
Print labels in high volumes quickly and efficiently, independent of printer make and model with Spectrum for Medical Device. The solution’s native drivers enable you to print to vast amounts of labels faster than ever before, in color or black-and-white, whether printing on your network, over the internet or via the cloud. Print to all leading printer models while maximizing print speed, optimizing network traffic and leveraging built-in printer capabilities. With Spectrum, there is no need to install and manage countless Windows drivers across your printer landscape.
Advanced Insight into Labeling Activities
Gain unparalleled insight with Spectrum for Medical Device’s Business Intelligence capabilities, which offers immediate access to your data from your labeling processes and activities in a convenient, interactive and customizable format. Empower administrators with customizable dashboards and pre-defined reports presenting real-time data on the status and health of labeling activities across your global enterprise. Spectrum’s Business Intelligence provides reporting of eSignature records and changes made to labels and other objects in Spectrum, to aid in audit tracking and compliance.
Manage Security and Access Across Global Deployments
With Spectrum for Medical Device you have control over which users have appropriate access including privileges to all partners, vendors and suppliers that are part of your labeling processes. Role-based access capabilities ensure your administrators can easily manage user roles and access labeling capabilities and content. Also, audit and session management capabilities enable visibility to user access and system changes to facilitate compliance in validated environments.
Save Time and Reduce Costs with Loftware Spectrum Validation Accelerator Pack
The Loftware Spectrum Validation Accelerator Pack (VAP) enables you to quickly and cost-effectively implement and maintain a validated and compliant labeling solution. Loftware’s VAP solution, which simplifies compliance, increases productivity and minimizes validation costs, complements Loftware Spectrum for Medical Device, the industry’s most powerful labeling solution designed to address the unique complexities and regulatory requirements of labeling in the medical device space. The VAP provides a standardized approach for ongoing validation and helps you validate your labeling processes to meet FDA and EU regulatory requirements. Paired with Loftware Spectrum’s configurable workflow framework and eSignature capabilities, the Loftware VAP provides a jump-start towards validation and helps to facilitate 21 CFR Part 11 compliance.
Enterprise-Class Architecture for Today’s Enterprise
With the flexibility to deploy in the cloud or on-premise, Spectrum for Medical Device meets the needs of any organization and scales easily as your business grows. By centralizing control over global labeling, Spectrum for Medical Device empowers locations across your enterprise, as well as external suppliers, vendors and partners, to access and use standard and approved labels and data.
Flexible Deployment Options
Transform your digital supply chain with Spectrum for Medical Device. Available in the cloud or on-premise, Spectrum for Medical Device offers flexible configuration options to meet your unique business needs. With Spectrum for Medical Device, you can quickly scale your labeling operations and improve consistency, auditability and availability throughout your organization and to supply chain partners.