Package inserts and instructions for use (IFUs) are the primary mechanism by which diagnostic manufacturers communicate important information about their products to healthcare professionals in accordance with national requirements. Since the revision of documents, which may occur more than once a year, is time-consuming and there is a delay between updating the information and making it available to users, DiaSys has decided to switch to e-labeling. E labeling refers to the fact that package inserts/IFUs as well as other product related documents such as safety data sheets or the symbol list are made available digitally only. Thus, changes to content or implementation of additional regulatory requirements may be realized immediately, as documents are accessible 24/7. Instead of re-printing and distributing costly hard-copy versions, updates are feasible with a minimum of additional cost and time.
E-labeling offers manufacturers and users many opportunities and advantages:
• Content consistency across markets
• Real-time update
• Reduction of DiaSys’s ecological global footprint
• Enhanced reliability
• Prevention of recall due to labeling errors
• Great transparency and traceability
• Permanent availability
Along with the implementation of e-labeling in the second quarter of 2022, DiaSys will introduce a search function on the website by which customers are guided directly to the required document.