Benefits of H-Vigilance
• Prepared notifications identical in content to Swissmedic forms
• Cache function for extensive notifications
• Ability to categorize messages
• Full control over users (roles and permissions)
• Evaluation via lists with Excel export
• Document upload for additional information
• Easily correct existing reports if the data situation changes - no new form necessary!
• Easy forwarding of corrected reports to Swissmedic
Marco Piffaretti
Project- and Account Manager
+41 628 5580 50
What can H-VIGILANCE do?
Central data collection
All vigilance cases are recorded centrally by the employees on a portal.
Central data storage
All relevant information on vigilance cases is stored centrally and documented in an audit-proof manner.
Effective case management
H-VIGILANCE enables the individual categorization of vigilance cases, the assignment of roles and authorizations, and the control of the processing process with deadlines, automated workflows, and smooth communication.
Secure data transfer
Vigilance reports are transmitted directly and fully automatically to Swissmedic, and data is transmitted securely and encrypted in accordance with the highest security standards.
This is what makes H-VIGILANZ* by new-win so insightful:
- Clearly structured reporting forms for haemovigilance, pharmacovigilance and materiovigilance identical in content to the Swissmedic forms
- Function for caching large messages
- Corrected reports can be forwarded to Swissmedic
- Excel export of vigilance messages
- Individual categorization of reports for internal case management
- Different roles for case management
- Record, schedule, process and control measures
- Documents can be uploaded in addition to the reports.
- Clear lists for processing reports
*There is no contractually agreed cooperation between swissmedic and new-win SW Solutions AG.
H-VIGILANCE – With safety for better patient safety!
With H-VIGILANZ from new-win, you actively contribute to improving patient safety in Switzerland while meeting all legal and regulatory requirements. Contact us today to learn more about H-VIGILANCE and take your vigilance management to the next level!
Conclusion
H-VIGILANCE is a comprehensive and easy-to-use vigilance software designed specifically for the needs of the Swiss healthcare system. With H-VIGILANCE, you can report and manage vigilance cases easily, securely and in compliance with the law, improve patient safety in your facility and at the same time meet Swissmedic requirements.
Blog articles about H-VIGILANCE
FAQ's
Is H-VIGILANZ also suitable for small outpatient organizations?
Small outpatient organizations are rarely or never confronted with reports to Swissmedic. For this reason, the use of H-VIGILANZ in such organizations is generally not indicated.
Are vigilance reports always submitted anonymously?
VIGILANZ reports are not submitted anonymously; the reporter must at least provide their initials. When transmitting a case to Swissmedic, the personal data of the organization's VIGILANZ officers stored in the system is included.
Can persons outside the organization also view VIGILANZ reports?
VIGILANZ reports can also be forwarded via email as PDFs to persons outside the organization.
Are the reports from H-VIGILANZ directly transmitted and documented to Swissmedic?
The reports processed by the vigilance officers can be directly transmitted to Swissmedic. The transmission is documented in the system with the date. In pharmacovigilance, cases can also be transmitted via the ELIVS portal.
Which types of vigilance reports to Swissmedic are covered by H-VIGILANZ?
H-VIGILANZ covers the following reports to Swissmedic:
Pharmacovigilance: Reporting of adverse drug reactions
Haemovigilance including Near Miss: Reporting of adverse events
Materiovigilance: Reporting of serious incidents
Can H-VIGILANZ also map complex corporate structures?
H-VIGILANZ can map complex corporate structures in the form of reporting circles.
Can the reporting systems be used on mobile devices (cell phone, tablet)?
The reporting systems work on mobile devices thanks to responsive design. No app installation is required.
On what basis are the annual subscription fees for the use of the reporting systems calculated?
You do not purchase software, but subscribe to a software service. Therefore, you only pay the subscription fees, there are no initial licenses or annual maintenance costs. The annual subscription fees are calculated based on the full-time equivalents (FTE), minus the trainees (apprentices) of an organization.
Do the reporting systems meet the requirements of the Swiss Data Protection Act (DPA)?
The reporting systems of new-win met the requirements of the Swiss Data Protection Act (DSG). The handling of personal data is contractually regulated within the framework of the new-win data protection provisions.
In which operating modes can the reporting systems be purchased?
• Software as a Service (SaaS): We offer you the operation of the reporting systems in the new-win cloud. • Rental subscription on premise: It is also possible to operate the software on customer-side infrastructure instead of in the cloud.
For which healthcare organizations are the reporting systems suitable?
The reporting systems from new-win are suitable for all organizations in the healthcare sector and are used in large university hospitals, nursing homes, Spitex organizations, and small outpatient facilities such as medical practices. The individual applications can be configured to meet the specific needs of the customers.
Make an appointment now!
In addition to your inquiry, you can arrange a meeting directly with our sales team
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