Loftware Spectrum for Medical Device
Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device enterprises to meet rigorous regulatory requirements. 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.
The most powerful labeling solution for the medical device industry
Ensure unprecedented control and consistency over label design
Keep full track of edits and approvals of label changes
Improve accuracy and efficiency with pre-configured applications
Maintain compliance with regulations like FDA UDI, EU MDR and FDA 21 CFR Part 11
Why Spectrum is the right solution for your medical device labeling needs
Effectively manage security and access
With Spectrum for Medical Device you have control over which users have appropriate access including privileges to your partners, vendors and suppliers. Role-based access capabilities ensure you can easily manage user roles and access labeling capabilities and content. Audit and session management capabilities enable visibility to user access and system changes to facilitate compliance.
Easily design and update compliant labels
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.
Streamline review and approval process
Automate and streamline labeling processes, 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.
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.
Streamline content management
Spectrum for Medical Device simplifies label design and approval processes by providing access to content and digital asset management functionality which supports version control required in validated environments. Spectrum enables comprehensive audit tracking while increasing label consistency by letting you build a library of pre-approved content available for use across your enterprise.
Meet demands with data-driven labeling
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.
Gain insights 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. Business Intelligence provides reporting of eSignature records and changes made to labels and other objects in Spectrum, to aid in audit tracking and compliance.
Leverage existing business processes
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.
Easily scale your labeling operations
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.
Save time and reduce costs with Loftware Spectrum Validation Accelerator Pack
Loftware and USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, have partnered to develop the Loftware Spectrum Validation Accelerator Pack (VAP) to simplify compliance, increase productivity and minimize costs. The Loftware Spectrum VAP enables pharmaceutical and medical device companies to quickly and cost-effectively implement and maintain a validated, compliant labeling solution.
When paired with Spectrum's configurable workflow framework and eSignature capabilities, the Loftware Spectrum VAP provides a jump-start towards validation and helps to facilitate 21 CFR Part 11, underscoring Loftware's ongoing commitment to pharmaceutical and medical device labeling.
The VAP templates are in MS Word and can be easily updated to include your specific information and project details.