Label Content Management
Medical Device Challenges
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Usually, most of the labeling is manual, copy/paste & repetitive, manual reconciliations of data points, a lot of QC checklists, and so on
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Maintained in documents (on desktops, shared drives, or general PLM/ERP) and with less traceability
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Knowledge in fewer hands (out of the door when they leave)
Our solutions help in bringing efficiency and save time/cost by right amount of digitization and automation
- Core Labeling: The Solution enables you to “digitally” create and maintain the lifecycle of all core labels. With effective impact analysis built-in, decide effective changes and once done, trickle-down those to other labels thereby reducing manual copy/paste and QC aspects.
- Label Compliance: As all labeling content and actions are linked well in the tool, Compliance management is at ease. All local label deviations and local deviation safety compliance can be viewed by simple reports by change, by version, by country, and by the user. HQ team also will have options to set rules/controls for alerts on deviations.
- Change Management: Regulatory change management is included where variations can be proposed, created, and tracked until implemented in the core labels. Changes proposed for core labeling processes are extended sequentially to the processes at each level (local product label, Artwork, Printing, and Supply Chain).
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