Does software comply with regulations for all markets in which the e-IFU will be supplied?
Yes. EU, FDA. EU MDR, eIFU are some of them.
How often we are updating country regulations?
Our team of expert regulatory professionals will regularly update the country specific regulatory requirements.
Are different versions maintained and how about languages?
You can maintain multiple versions and ViSU has multi-country & multi-language features included.
Where is Data & Documents hosted?
Data is stored in our “Private cloud” hosted in ISO 27001 certified Data center in Frankfurt, Germany (optionally we can give NJ, USA as another option)
Is software validated (21 CFR part 11 / GAMP)?
Yes. ViSU is validated as per 21 CFR part 11 and GAMP for electronic records and electronic signatures to ensure accuracy, reliability and consistent intended performance
What data security is followed?
All sensitive data information are encrypted end-to-end including data at-rest and in-transit using User management and access control/restriction are followed to ensure only the right people have access to data at the right time and also personal information is accessible only to those authorized who we believe reasonably need to come into contact with that information to provide products or services.
Is this GDPR compliant?
Yes. Procedural safeguards, security measures and Privacy Policy are in compliance with GDPR to protect and safeguard GDPR principles
