e-Signatures

Electronic Signatures for ISO 13485 and FDA 21 CFR Part 11 compliance

Streamline approvals and meet the regulation

For medical device developers, a compliant e-signature package should come as standard. You don’t need expensive biometric solutions to meet the regulation and you shouldn’t be paying extra for third-party integrations either.

Your e-Signature package should help you:

Prevent falsification of records
Show the ‘meaning’ of every signature on a document
Ensure full traceability of all decision making
Create a complete audit trail of changes and approvals

Don't just take our word for it.

Cognidox is easy to use and simplifies processes! The support and training provided are fantastic.

Julie Errington, Clinical Trials Manager at NCCPG

The entire process from demo, training and implementation has been wonderful. The acceptance of the tool within the organization was very fast and growing by the week! This is a very versatile product and is simple to use. The workflows are very powerful and helps build compliance to several standards with ease.

Prasanna, COO

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and is saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

Cognidox is by far the easiest eDMS/eQMS to use and scores with a full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file-type and does not use thrid-party "logic", such as MFiles or alike.

Guenter Duerr, Director at Capsero

The system is flexible and can easily be customised to your organisational needs. The price point makes it an option for small companies that could benefit from an eQMS but do not have the funds to go with the more popular packages.