Loftware’s medical device labeling compliance
Loftware Spectrum for Medical Device digital platform is designed to meet the requirements of medical device manufacturers and support the challenges of labeling in validated environments. It provides new levels of control so companies can 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.
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.