Loftware Spectrum® for Medical Device Purpose Built to Enable Compliance for UDI, EU MDR and 21 CFR Part 11
Portsmouth, NH - May 22, 2019 – Loftware, Inc., the global leader in Enterprise Labeling and Artwork Management Solutions, today announced the availability of Loftware Spectrum for Medical Device. This digital platform is specifically designed to meet the unique requirements of device manufacturers and support the challenges of labeling in validated environments. It provides new levels of control so companies can more effectively manage regulatory requirements, including UDI, EU MDR and 21 CRF Part 11, across their global enterprise.
Spectrum for Medical Device helps companies manage labeling, including the design, approval and validation of labels and other content across multiple environments from test and QA to validation, development and production. Available in the cloud or on-premise, the solution offers a configurable workflow framework and eSignature capabilities to provide new levels of visibility, full audit tracking and powerful control for managing labels. The solution offers GS1-ready label templates and a comprehensive set of stock symbols to streamline the label design process and enable compliance with industry regulations.
“We understand the challenges involved in meeting evolving regulatory requirements as medical device companies implement, deploy, maintain and scale their labeling operations globally. Loftware’s depth of knowledge and vast experience in the medical device space enables us to fully address the unique needs of this market,” stated Josh Roffman, Loftware Vice President of Product Management. “We’ve been able to extend the power of Spectrum with pre-configured applications, giving medical device companies a head-start by providing best practices and procedures within the solution to help them save time and reduce costs associated with implementing a validated labeling environment,” he added.
To manage common labeling processes required for medical device manufacturers, Spectrum for Medical Device includes six pre-built applications which provide a “wizard-based” approach to guide users down the appropriate paths, removing any guesswork or potential for human error. Device manufacturers can use or modify pre-existing applications or create new ones for labeling or other business processes via a drag-and-drop user interface.
For additional control and consistency, Spectrum provides layering capabilities for label design which enables different groups or departments to own and control a portion of a label’s real estate, allowing relevant stakeholders to review and approve layers. Additionally, multi-label layouts give Spectrum for Medical Device customers flexibility and efficiency when printing, allowing labels with different content and sizes to be added in a single layout that can be printed all at once.
Role-based access control offers administrators control over user roles and assigns appropriate access to labeling content. This includes managing access privileges to all partners, vendors and suppliers that are part of the medical device labeling processes. Additionally, audit and session management capabilities enable visibility over user access and system changes, which helps to facilitate compliance in validated environments.
Spectrum for Medical Device provides Business Intelligence capabilities, offering immediate insight about labeling processes and activities in a convenient, interactive and configurable format. Pre-built dashboards and 25 pre-defined reports present real-time analysis on the status and health of labeling activities across a global enterprise. Additionally, Spectrum’s audit capabilities can capture and report on all user actions including who made what change and when.
Additionally, companies can get an additional jump start toward validation when pairing Spectrum Medical Device with the Loftware Spectrum Validation Accelerator Pack (VAP) which provides a set of content-rich validation templates that are ready to be configured to reflect specific implementation decisions.
Loftware is the global market leader in Enterprise Labeling and Artwork Management solutions with more than 5,000 customers in over 100 countries. Offering the industry’s most comprehensive digital platform, with SaaS, cloud-based and on-premise solutions, Loftware redefines how enterprises create, manage and print complex labeling and packaging artwork and scale across their operations. Loftware solutions integrate with SAP®, Oracle® and other enterprise applications to produce mission-critical barcode labels, documents, RFID smart tags and packaging artwork. Our combined platform–whether for labeling, artwork management or both–enables customers to uniquely meet regulatory mandates, mitigate risk, reduce complexity, ensure traceability, improve time to market and optimize costs as they meet customer-specific, brand, regional and regulatory requirements with unprecedented speed and agility.
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