The Industry’s Most Powerful Enterprise Labeling Solution for the Medical Device Industry

spectrum-auditingLoftware 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.

Fast and Efficient Label Design

Loftware Spectrum for Medical Device simplifies your label design process. With sample label templates that enable compliance with GS1, a library of stock symbols and powerful drag-and-drop label design capabilities accessible from any seat in the organization, users can create or modify labels quickly, reducing the time to production. Spectrum’s WYSIWYG interface and ability to include live data guarantee that your labels print as they appear on your screen. Role–based access controls provide additional security and control, helping you determine which users have access to which labels—and can even help you define who can view, edit or print down to the granularity of a level in the label.  Spectrum’s workflow management routes and tracks labels from design to approval, with built-in eSignatures and full version tracking.

Spectrum for Medical Device’s dynamic data driven labeling enables you to create labels and manage mass label changes by allowing you to access content, symbologies and language to meet extensive levels of variability. With Spectrum’s universal label templates, you can create a single template that can drive any printer make and model. You can also easily compare and highlight differences in labels with Loftware DaVinci, a powerful capability in label design that streamlines the design and approval process. For additional control and consistency, Spectrum provides layering capabilities which enable different groups or departments within an organization to own and control a portion of a label’s real estate, allowing relevant stakeholders to review and approve layers. Additionally, multi-label layouts offer Spectrum for Medical Device customers flexibility when printing by allowing labels with different content and sizes to be put together in a single layout that can be printed all at once.

 

Empower Users to Create Custom Applications

Spectrum for Medical Device comes pre-configured with six commonly-used applications supporting labeling processes, including preparation, sample print, print, post processing, historical reprint with reason comment required and summary reporting, for the medical device manufacturer. Application Architect replaces custom-developed applications, as well as manual, paper-based processes, by automating your labeling and business processes. This reduces the risk of mislabeling while saving time and ensuring consistency. Spectrum for Medical Device enables you to design applications with drag-and-drop ease to make the development and maintenance of applications (often used for on-demand printing) dramatically faster and easier. Application Architect’s flexible nature enables applications to be designed to meet the unique needs of each customer without requiring custom development. This means that you don’t need to worry about applications “breaking” after upgrading to new versions of Spectrum for Medical Device.

Application Architect can also drive decisions based on input from users, providing a “wizard-type” user interface that leverages Spectrum for Medical Device’s business rules. The application guides users down the appropriate path to remove guesswork and reduce the occurrence of labeling errors. Applications can be designed to look-up and display data needed for processing that resides within the Spectrum database or an external application/repository such as SAP or Oracle. Also, you can brand forms and applications to meet internal or customer/partner requirements.

Spectrum for Medical Device’s applications are supported any platform, including mobile devices, via the web browser, providing maximum flexibility during label processing. Additionally, applications created in Application Architect can be used for on-demand print requests, enabling users to scan, enter or lookup data needed to drive the label creation and kitting process. Paired with Spectrum’s role-based security, administrators can ensure that only the right individuals have access to the correct set of labels or devices and can submit on-demand print requests, from any location and from any device.

Automate Configurable Workflow to Streamline Labeling

Spectrum for Medical Device provides a powerful and highly configurable workflow engine to track and manage labels through their lifecycle from initial creation to approval to publish. Extensive workflow capabilities enable you to have workflow and approval processes that adhere to your business processes and help you comply with medical device labeling regulations. You can create multiple workflows and include users in the process as your business dictates. In addition, workflows can be configured to support an unlimited number of tasks and approvers, while allowing for eSignatures for validated environments.

Spectrum’s workflow capabilities offer the advantage of replacing outdated and time-consuming manual processes with automated ones. This results in increased efficiency in label creation and approval, while also consistency across processes. Spectrum allows reviewers and approvers to be notified when they need to act, enabling them to easily approve or annotate labels with comments. You can see the status of labels as they transition between pre-defined workflow states as workflow metadata is captured for future reporting purposes.

Also, implementing compliant processes for labeling is critical in the medical device industry. Spectrum for Medical Device’s workflow capabilities seamlessly enable users to adhere to existing processes and reduce the risk of non-compliance. Auditing at each step of the workflow provides the traceability that you need to track who does what and when. Additionally, eSignature capabilities help enable 21 CFR Part 11 and EU Annex 11 label compliance by providing a formal and verifiable approval or rejection of a label.

Certified Integration to Leading Enterprise Applications

Spectrum for Medical Device is designed to integrate with any type of enterprise application(s) including ERP, PLM and/or content and artwork management solutions, while providing pre-built integration with leading players such as SAP, Oracle, JDE, Infor and many others, as well as with custom-built applications. Whether you deploy on premise or in the cloud, Spectrum for Medical Device is designed to integrate with your enterprise applications to ensure that your label data is sourced from your sources of truth. By integrating labeling with your business applications, you leverage existing business processes and vital data sources to achieve label accuracy and consistency—while eliminating data duplication.

Loftware's flexible, certified SAP labeling solutions are specifically designed to integrate with SAP S/4HANA , SAP Business Suite on HANA, and SAP ECC. Spectrum for Medical Device integrates directly to SAP’s output management and provides certified integration via Adobe Interactive Forms, Smart Forms, Remote Function Call (RFC) and RDI. As the only Medical Device Enterprise Labeling solution on the Oracle Cloud Marketplace, Spectrum offers seamless integration with Oracle Cloud applications while providing OVI certified integration to Oracle E-Business Suite including Oracle WMS and MSCA.

Spectrum for Medical Device’s REST and SOAP Web Services allow you to integrate with any application(s) used for your organization’s label data and printing. When printing labels on-demand as part of your kitting or WIP processes, Spectrum for Medical Device can retrieve data from your source of truth using web services to ensure accuracy. Using Spectrum’s event-based integration further extends your labeling processes by leveraging Java Message Service (JMS) allowing Spectrum for Medical Device to both publish and subscribe to events from external applications.

Dynamic, Data-Driven Labeling to Meet Evolving Demands

Spectrum for Medical Device enables you to automate your labeling processes and support increasingly complex requirements by using flexible business logic that is designed to manage variability in labeling. Spectrum’s configurable business rules allow business users to address changes and new requirements without having to build custom logic in the enterprise applications that often provide required label data. With Spectrum for Medical Device, you can leverage the data from your systems of record and configure rules that dynamically change label content based on that data. This streamlines label formatting and printing so you can easily manage regional, language, regulatory and customer-specific requirements. And, business users can make changes and updates in hours or days rather than months ensuring that requirements are met in a timely fashion.

Business rules can execute logic such as gathering data for a label, selecting a device for a label, or determining the information that needs to be printed on a label. You decide what rules and decisions need to be made based on your data and your processes. Sample business rule components designed specifically for the medical device industry are available as a starting point. Previously created business rules can be reused, enabling business users to quickly build and adapt business logic as necessary for their labeling applications and processes. Configurable business logic also reduces the number of labels you need to manage since dynamic changes can be made to fewer templates, rather than making new templates for every variation of a label.

Spectrum for Medical Device offers a Business Rules Configurator to provide a user-friendly, drag-and-drop interface that empowers non-technical business users to implement business logic to greatly streamline the process of creating, updating, and reusing Spectrum’s powerful business rules. Additionally, Spectrum offers powerful workflow and versioning capabilities that streamline the approval and application of business rules.

Streamlined Content Management for Improved Efficiencies

Spectrum for Medical Device’s powerful content management capabilities support your labeling processes and activities, offering you with a consolidated source of label content to complement integrated label data. By providing robust content and digital asset management, Spectrum allows you to store and manage data and images used for labeling that may currently reside in external spreadsheets or custom-built databases. Spectrum for Medical Device is designed to optimize your printing for labels that include real-time data from integrated applications alongside data and images you store within its content management repository.

Examples of content that can be stored, accessed and managed in Spectrum for Medical Device includes images, phrases, translations, artwork, or standard text/copy. You can route your content through workflows, manage versions/changes, or store them with configurable metadata. You can guarantee that you have the latest content and can easily reference it based on parameters that you define. Spectrum for Medical Device’s content management lets you know whether an item has been formally approved, by whom and when, as well as where it is used. For example, if a company logo needs to be replaced, Spectrum for Medical Device can help you identify which labels use that logo and need to be updated.

Spectrum for Medical Device’s content management allows you to store PDFs or images of printed labels that can serve as a digital twin of the labels that are printed. These PDFs and images can be used as a digital record you can use for traceability, audits or first article inspection purposes. In addition, you can quickly determine differences in versions of a label using Loftware’s Davinci comparison tool.

Printing with Unrivaled Performance

Loftware Spectrum for Medical Device offers unrivaled performance and scale, enabling you to optimize your label printing across your global network of printers and locations. Spectrum for Medical Device empowers many of the world’s largest companies to print millions of labels a day across hundreds of global sites with a single instance of Spectrum.

Spectrum for Medical Device’s native printer drivers support thousands of printer makes and models across your diverse global universe of printers, dramatically improving performance and enabling native color printing. These native drivers, which include support for Scalable Vector Graphics (SVG) images, minimize print streams and reduce network traffic to maximize print speeds. You do not have to install or maintain them locally as you do with Windows printer drivers. Additionally, native print drivers improve label printing performance throughout organizations, ensuring highest levels of performance across the organization, including in remote locations. By optimizing print performance and reducing maintenance efforts, native drivers help you save substantial time and money.

Spectrum for Medical Device also supports printing multi-label layouts, allowing you to combine different sized labels in a single layout. This enables you to print the multiple labels required for a medical device on a single “multi-label” layout/sheet, which simplifies label management, saves time and enhances label printing flexibility. Spectrum’s business logic allows you to determine the label content for printing based on pre-configured rules.

In addition, Spectrum for Medical Device gives you visibility into the status of your print devices, providing the ability to control them at both the global or local level. Spectrum’s remote printing capabilities mean you can print over the internet without relying on network connectivity to printers. This allows you to extend printing to remote sites and supply chain partners while maintaining the same level of performance, quality and security as when printing to networked devices. And, Spectrum for Medical Device’s sophisticated queue management allows total control over label printing, including the ability to pause, restart, move and delete print jobs. For example, you can pause jobs until you are ready for them to print or move them from a printer that is in an error state to one that is operational.

Advanced Insight into Labeling Activities

Loftware Spectrum for Medical Device brings a new level of insight into Enterprise Labeling enabling you to be better informed and drive improvements to labeling processes. With configurable dashboards and 25 pre-defined reports, Spectrum for Medical Device’s Business Intelligence (BI) offers you advanced analytics and real-time reporting on vital information including labels, printers, print jobs, users and audit data. It offers you a wide range of capabilities including the ability to drill down for more details or easily remove/add variables on a report, expand or reduce timeframes on a report.

Spectrum for Medical Device’s BI lets you identify underutilized printers or longer than expected print times allowing you to make the proper adjustments. You can also monitor label output across facilities to identify anomalies in label production to effectively identify and respond to areas of concern.

In addition to Spectrum for Medical Device’s pre-defined reports, you can create your own custom reports and configure dashboards to suit your needs and make better decisions. Reports and dashboards can include information from external data sources to present a critical view across disparate data sources into a single view. Reports created in Spectrum for Medical Device’s BI can be formatted as either single or multi-page reports, which can also be exported in up to 11 different formats including PDF, CSV, RTF, and Excel.

Additionally, you can have real-time visibility to audit data with the flexibility to create custom audit reports, set up audit dashboards and run ad hoc reports. This is essential for validated environments, where administrators require real time access to a detailed and complete view of all user activity (labels that were printed, content on a label that was changed, device configurations that were updated, etc.). If you need to track user activity for 21 CFR part 11 or EU Annex 11 requirements, Spectrum for Medical Device’s audit capabilities can capture and report on all user actions including who made what change and when. You also have the flexibility and control to decide what audit detail level setting you need for your organization.

Manage Security and Access Across Global Deployments

Loftware Spectrum for Medical Device brings maximum security and control to all your labeling activities. With Spectrum you can provide simple and immediate browser-based access to users while maintaining complete control over their access to capabilities and data. Spectrum for Medical Device’s role-based access control ensures administrators can easily manage users and groups as business conditions demand. This also enables seamless collaboration for extending labeling activities to suppliers, partners, vendors, and other third parties involved in the labeling processes.

Spectrum for Medical Device gives you the control to manage users access, so you can determine who can have access to system capabilities such as design, printing, business intelligence and security. At the same time, you can optimize the user experience by configuring who can view/access/edit objects including labels, printers and applications. Additionally, Spectrum provides global oversight, enabling centralized control and oversight while allowing local administration of users, printers and labels to offer you the best of both worlds.

With Spectrum for Medical Device you don’t have to worry about yet another username/password to be managed by users or other groups such as security or IT. Spectrum supports single sign-on (SSO), streamlining access to Spectrum via standard, third-party authentication. In addition, Spectrum for Medical Device ’s session management capability adds the ability to view and control user sessions for ad hoc or planned system maintenance. This allows you to broadcast important system notices or planned downtime to inform users, so they may plan accordingly.

When deployed in the cloud, Spectrum for Medical Device provides additional advanced security capabilities and leverages Amazon Web Services (AWS) to protect your data and maintain availability.

Save Time and Reduce Costs with Loftware Spectrum Validation Accelerator Pack

Now you can streamline the validation workload for a standardized Enterprise Labeling Solution while meeting evolving FDA and EU regulatory requirements.

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.

The Loftware Spectrum VAP leverages the industry's most powerful barcode labeling solution to address the unique complexities of labeling in the life sciences space. 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.

As USDM's only VAP for an Enterprise Labeling Solution, the Loftware Spectrum VAP provides a set of content-rich validation templates that are ready to be configured to reflect your implementation decisions: Validation Plan

  • System Requirement Specifications
  • Functional Risk Assessment
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Traceability Matrix
  • Validation Summary Report
  • 21 CFR 11 Assessment

The VAP templates are in MS Word and can be easily updated to include your specific information and project details.

Download the Loftware Spectrum VAP data sheet for the Medical Device Industry.

To learn more about getting started with your Loftware Spectrum VAP, contact us at Sales@loftware.com

"The Loftware VAP helps life science companies meet regulatory challenges, while reducing validation time and costs up to 50%."
- Jay Crowley, Vice President
UDI Services and Solutions, USDM Life Sciences

Enterprise-Class Architecture for Today’s Enterprise

Loftware Spectrum for Medical Device was architected from the ground up as an enterprise-class application to support the growing needs of your organization so you can manage and scale your global labeling with ease. With centralized control over labeling, Spectrum for Medical Device offers flexibility to be deployed in the cloud or on-premise and is built to effectively manage, scale and support enterprise-wide labeling operations.

You can reap the benefits of both centralized and decentralized deployment models with Spectrum for Medical Device’s Multi-Site capabilities, which offer unprecedented flexibility to standardize labeling across a global supply chain. This functionality allows you to leverage a single deployment across multiple geographies and remote facilities while synchronizing labeling and data with a central location. Business users at facilities including manufacturing plants, contract manufacturer sites, warehouses, and distribution centers can manage labeling independently when required, while accessing standard and approved label templates and integrations from a company’s central location. This ensures continuous uptime by empowering facilities to run without depending on a full-time connection to headquarters, while also ensuring that they comply and stay current with corporate labeling standards.

Spectrum for Medical Device lets you manage and control user access, enabling you to support labeling across your global facilities or third-parties such as suppliers and distributors. This enables collaboration across your extended supply chain. To support regional operations, Spectrum for Medical Device’s user interface provides support for multiple languages, including Brazilian Portuguese, English, French, German, Japanese, Korean, Russian, Simplified Chinese, Spanish and Traditional Chinese. Also, Spectrum for Medical Device’s Disaster Recovery capabilities ensure that your labeling will not be interrupted in the event of a catastrophe while high availability allows your environment to balance the load and optimize performance during peak operational times.

Flexible Deployment Options

Loftware Spectrum for Medical Device provides the ultimate flexibility for customers to choose to deploy either on-premise operations or in the cloud as a service. As the market leader in Enterprise Labeling Solutions, Loftware allows you to choose the Spectrum for Medical Device configuration that aligns with your infrastructure strategy. If your business preference is to control and manage your infrastructure on-site, Spectrum for Medical Device on-premise offers complete control of your Windows or Linux environments.

Deploying Loftware Spectrum for Medical Device in the Cloud as a service removes the need to purchase, install and maintain hardware and software environments required for on-premise deployment. This reduces infrastructure and management costs while ensuring that labeling services scale to meet global business demands. A cloud deployment of Spectrum for Medical Device enables you to implement new labeling processes faster, with less dependence on IT and more control from business lines.

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