EU Annex-11 Complaint – FidNos Corporation

- EU Annex 11’s Section 2,Personnel / Training: QMS – saves all the data/documents in a centralized form, connecting various departments & users (employees). Access is granted only to the qualified personnel’s via the user management modules. QMS has a Training module as well as TNI modules to cover “training management” .

- EU Annex 11’s Section 9, Audit Trails: QMS has built in Audit Trails, which can be viewed by the admin / MR user. These are view level audit trails. QMS records every details like Login Session Details, pages access, edits made & previous to current record changes. QMS also logs all the application (system) level errors in its application logs folder.

- EU Annex 11’s Section 12, Security: QMS does not allow any unauthorized access to any personal. Application is fully protected by Password (which are encrypted). The entire application is secured by .htaccess/web.config file on the server. Additionally, SSL certificates can be installed on your servers. QMS is incorporated with additional 2 Way Authentication system which consists of Username/Password as well as Digital Signature authentication.

- EU Annex 11’s Section 14, Electronic Signatures: Digital Signature Included, as well as optional email OTP is available.
- EU Annex 11’s Section 17,Archiving: QMS does not delete any document automatically, hence documents can be managed as per your data retention policy. QMS also provides revision control, archiving. Apart from these, once the corn jobs are configured correctly, QMS regularly backs up the entire application along with files & database on your server.

FidNos Corporation