An AI tool was used to translate this article from German.

Vigilance becomes a freestyle activity:

For more relief and a better overview, we recommend a three-point program:

• Use an electronic reporting system.
• Standardize the reporting process.
• Use the vigilance messages for your quality management.

This will enable you to integrate vigilance messages much more efficiently into your day-to-day work and soon make them a matter of course.

Use an electronic reporting system

An electronic reporting system opens up new possibilities – particularly beneficial for your company in conjunction with your quality management. In Switzerland, H-VIGILANZ is the established reporting system for materiovigilance, pharmacovigilance and haemovigilance with NearMiss. Those responsible for vigilance administer all vigilance reports via the system and thus always maintain an overview. By using the reporting system, vigilance is automatically given a higher priority in your organization. There are numerous functions that facilitate this:

• Everyone is clear about how to deal with vigilance messages.
• Employees have quick access to the reporting form (case entry) via a portal page.
• The user-friendly interface makes it much easier to complete the notification.
• Additional form fields for information that is relevant to you can be integrated into the system.
• The reports in the system provide you with a good data basis from which to derive targeted measures.

Standardize the reporting process

Fortunately, cases of vigilance do not occur every day. But when they do, you should know what the reporting procedure looks like. Without a standardized reporting process and without a reporting system, it is quite possible that the responsibilities and the exact procedure for reporting are not known at all to the employees concerned. In addition, sometimes events occur for which it may not be clear whether they need to be reported to Swissmedic or not. This is where H-VIGILANZ can help with a clear reporting process, as the procedure and responsibilities must be defined and integrated. What does a standardized reporting process look like?

1. Anyone can submit vigilance reports because the reporting form is easily accessible.
2. Employee reports are automatically forwarded to the responsible vigilance officer. The contact information is stored in the system.
3. The vigilance officers process the reports in detail.
4. The persons responsible for vigilance can involve other persons in the processing via the reporting system.
5. Once processing is complete, the vigilance reports with integrated signature are sent to Swissmedic via the reporting system.
6. The reports remain accessible in the reporting system and are still available for internal purposes, such as evaluations and the derivation of measures.

Use the vigilance messages for your quality management

Knowing means being able to improve quality: Numerous functionalities that go beyond recording and sending vigilance messages make H-VIGILANZ an important tool for quality management.

• Because every employee can record vigilance reports, the reporting system creates a basis for a more conscious approach to vigilance cases and quality in general.
• The CIP (continuous improvement process) is supported by recording measures for the vigilance reports.
• Individual additional fields provide you with supplementary information on the notifications that you can use for your QM statistics.
• Are there any vigilance reports that have not been submitted to Swissmedic but are relevant for internal purposes? These reports are also processed and stored.
• In the reporting system, you can access the reports at any time, as well as additional information from the attached documents or images.

Would you like to free your vigilance reports from their neglected existence? Then it is worth introducing a reporting system. You can find further information on this topic to help you make a decision here:

• H-VIGILANZ, vigilance reporting system from new-win SW Solutions
• Swissmedic Pharmaco-vigilance
• Swissmedic Hemo-vigilance and NearMiss
• Swissmedic Materio Vigilance.

We hope we have been able to give you a clear understanding of the benefits of professionalizing vigilance reporting and integrating it into quality management. If you have any further questions, please contact our team at any time, we will be happy to provide you with information and familiarize you with the products.