EU Annex-11 complaint QMS

Five areas supported by FlinkISO

Annex 11 control overview

Personnel and Training

FlinkISO saves data and documents in a centralized form, connecting departments and users. Access is granted only to qualified personnel through user management modules. FlinkISO also provides Training and TNI modules to cover training management.

Audit Trails

FlinkISO has built-in audit trails viewable by Admin and MR users. It records login session details, page access, edits, and previous-to-current record changes. Application-level errors are also logged.

Security

Application access is password protected, passwords are encrypted, and server configuration can be protected through .htaccess or web.config. SSL certificates can be installed on the server. FlinkISO 2.x also provides username/password and digital-signature authentication.

Electronic Signatures

Digital Signature is included, and optional email OTP is available.

Explore digital signatures

Archiving

FlinkISO does not delete documents automatically, allowing documents to be managed according to your data retention policy. It provides revision control and archiving. When cron jobs are configured correctly, the application, files and database can be backed up on your server.

More Features

ONLYOFFICE Doc Editors

With ONLYOFFICE™ Editors, you have complete control on your documents without loosing any formatting unlike online web-based HTML editors.

Document Version Control

Each and Every QMS document created/ uploaded in the QMS is Version Controlled and Access Controlled and follows all the Document Management best practices.

In their own words

What Clients Say?

Testimonials

We’ve been using FlinkISO for about a year, and it has become a key tool for managing our QMS for ISO 9001 and ISO 27001.

The platform is powerful yet straightforward—easy to navigate, quick to understand, and practical for day-to-day work. The team support is also excellent: fast, responsive, and genuinely helpful whenever we need it.

Overall, it’s a highly reliable solution and, in our experience, one of the best QMS tools available today.

Victor Casas
LABY - Forever Data, Spain

The FlinkISO Online System certainly has revolutionized our business, it certainly allows us to work "smarter, not harder".

The online tracker, database, reports and graphs etc, have outperformed our initial system.

All the documentation is accessible at the press of a button, needless to say we are proud to be affiliated with you and with this level of professionalism.

Mrs. V. Donjeany
LEPRO Corporation CC, South Africa.

We have been using FlinkISO as our Quality Management Software for the past few years and we are extremely satisfied with the software and services offered.

The support team installed the software for us and worked with us to customize our Quality Management website which made the transition from a paper-based system to an online one effortless.

They always respond promptly to any questions or inquiries and have processed our web customization requests with speed and reliability.

I would highly recommend their services.

Priyangi Perera
Pro-Lab Diagnostics, Round Rock, Texas.