Streamline the Production and Distribution of Regulated Documents

The Instructions for Use (IFU/eIFU) for a medical device or pharmaceutical product are considered part of the product and a critical part of labeling process. While all regulatory agencies require certain information such as step-by-step instructions and use-by-dates on all IFU documents, other required content can vary significantly by region, making the management and production of these documents a complex and time-consuming process. The regulators who approve these documents may also set limits on factors like fonts and font sizes, visuals, spacing and colors used. Any change to an approved IFU must be re-evaluated for approval.  

Managing content and their translations, maintaining version control and integrating source data with label printing and output capabilities are critical functions in the production of Instructions for Use. Loftware solutions help you manage IFU and eIFU production and distribution more effectively by enabling you to: 

• Manage changes, review and approval cycles proactively with advanced workflows that automate your IFU creation/update processes and provide audit tracking and reporting  
• Preview PDF documents and deliver formatted content electronically for eIFU creation  
• Bring order and control to your textual and image content with Loftware’s centralized phrase library and Digital Asset Library (DAL) 
• Automate formatting adjustments with sophisticated template design capabilities  
• Guarantee that only approved templates and content are used with version control   
• Automate proofing of images and text to identify and report differences more accurately and efficiently than is possible with the human eye  
• Provide greater consistency and accuracy and eliminate data duplication with centralized content management