H-VIGILANZ: Intelligent vigilance software for patient safety in medicine

H-VIGILANZ – Simple and Secure Vigilance Reporting System for Medicine

With H-VIGILANZ, the innovative vigilance software from new-win, you fulfill your duty to report serious incidents to Swissmedic. The software, which maps the reporting forms for Materiovigilance, Pharmacovigilance, and Hemovigilance, is easy to use and meets all legal requirements of Swissmedic.

H-VIGILANZ: Intelligent vigilance software for patient safety in medicine

H-VIGILANZ – Simple and Secure Vigilance Reporting System for Medicine

With H-VIGILANZ, the innovative vigilance software from new-win, you fulfill your duty to report serious incidents to Swissmedic. The software, which maps the reporting forms for Materiovigilance, Pharmacovigilance, and Hemovigilance, is easy to use and meets all legal requirements of Swissmedic.

H-VIGILANZ: Intelligent vigilance software for patient safety in medicine

H-VIGILANZ – Simple and Secure Vigilance Reporting System for Medicine

With H-VIGILANZ, the innovative vigilance software from new-win, you fulfill your duty to report serious incidents to Swissmedic. The software, which maps the reporting forms for Materiovigilance, Pharmacovigilance, and Hemovigilance, is easy to use and meets all legal requirements of Swissmedic.

Benefits of H-Vigilanz

Clearly structured reporting forms

• Processed reports content-wise identical to Swissmedic forms • Temporary storage function for extensive reports

Internal case management

• Categorization option for reports • Full control over users (roles and permissions)

Uncomplicated evaluation

• Evaluation via lists with Excel export • Document upload for additional information

Simple correction procedure

• Easily correct existing reports when data changes - no new form needed! • Simple resending of corrected reports to Swissmedic

Marco Piffaretti

Project- and Account Manager

m.piffaretti@newwin.ch

+41 62 855 80 50

Make an appointment now

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What can H-VIGILANZ do?

Central Data Collection

All vigilance cases are centrally recorded by employees on a portal.

Central Data Storage

All relevant information on vigilance cases is centrally stored and documented in a tamper-proof manner.

Effective Case Management

H-VIGILANZ enables the individual categorization of vigilance cases, assignment of roles and permissions, and management of the processing workflow with deadlines, automated workflows, and seamless communication.

Secure Data Transmission

Vigilance reports are transmitted directly and fully automatically to Swissmedic, with data transmission being secure and encrypted according to the highest security standards.

What makes H-VIGILANZ* from new-win so insightful:

Clearly structured reporting forms for Hemovigilance, Pharmacovigilance, and Materiovigilance, content-wise identical to Swissmedic forms
Function for temporarily storing extensive reports
Possibility to resend corrected reports to Swissmedic
Excel export of vigilance reports
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 the reports

*There is no contractually agreed cooperation between Swissmedic and new-win SW Solutions AG.

H-VIGILANZ – Ensuring 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-VIGILANZ and take your vigilance management to the next level!

Conclusion

H-VIGILANZ is a comprehensive and user-friendly vigilance software specifically developed for the needs of the Swiss healthcare system. With H-VIGILANZ, you can report and manage vigilance cases easily, safely, and in compliance with the law, improve patient safety in your facility, and meet the requirements of Swissmedic.

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Blog articles on H-VIGILANZ

Patient safety, Swissmedic

Meet Swissmedic requirements in no time at all with H-VIGILANZ

Quality management, Reporting systems, Vigilance messages

Vigilance messages: Turn your duty into an option!

Software as a service

Rent software instead of buying

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FAQs

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.

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