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

In this video, we'll walk you through how to manage your electronic signatures effectively with Cognidox. Discover how to streamline approvals, maintain compliance, and ensure secure documentation across your processes.

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.

Linda Garrod, Quality Consultant at Ivdeology

The search facility sits at the top of the interface at all times and is extremely powerful and quick, and the advanced search facility is excellent.

David Ahern, CEO at Coalesce Product Development

Cognidox is a very versatile software, pre-configured for many different Quality Management Systems and yet very easy to use and configure.

Fabio, CEO

How Cognidox helps

Cognidox’s e-Signature solution ensures:

You have complete control over the use of e-signatures in your system
e-Signatures are unique (cannot be shared or falsified)
e-Signatures are password protected (with passwords changed frequently)
Create a complete audit trail of approvals
Approvals can always be linked to a specific individual
e-Signatures are part of a complete audit trails
Documents show the printed name of the signatory
Documents show the date and time a signature was applied
Documents show the meaning of the approval - i.e. what the signatory intended
The signing event is added to the documents’ secure audit trail
The signature cannot be removed once it is applied

Explore all the eQMS platform features

Lean eQMS

A Quality Management System right-sized for your needs

Document Management

Digitise your document control

Design Controls

Phase gate and document your entire design process

Business Management System

Ensure oversight and control with graphical business management

Extranet & Collaboration

Fast and secure information management

CAPAs & Non-conformance

Detect, correct, and prevent quality failures

Supplier Management

Monitor and manage supply chain quality

Learning Management

Tracking and self-attestation made simple

Change Management

Change control when it matters most

See Cognidox in action

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.

Some of the most frequently asked questions

e-Signatures

Are your e-signatures FDA 21 CFR Part 11 compliant?

Yes. Cognidox implements the Part 11 controls for identity, intent, record integrity, and audit trails. When a user approves a record, they must confirm their role, state a reason for approval, and re-authenticate (username + password or an approved authenticator app). The signature is bound to the exact version and an approval manifest is added to the document, capturing signer, role, reason, timestamp, and a tamper-evident hash. The manifest also carries the full approval history across versions, giving auditors end-to-end traceability.

Can we restrict who can sign what?

Roles/permissions enforce signer eligibility. These can be assigned to areas of the system, across specific record types, via assigned security profiles or on individual documents; workflows require required signers.

Do you support DocuSign as well?

Yes—use Cognidox native e-signatures or use the DocuSign integration where preferred; both keep records inside the DMS/QMS.

How are time stamps and records preserved?

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Can we revoke or supersede a signature?

Superseded documents are clearly marked; new signatures apply to new versions with full traceability.

Does it work on mobile?

Yes—responsive UI allows compliant signing on approved devices with the same controls.

What does Part 11 actually require for e-signatures and records?

Part 11 expects validated systems, unique user IDs with authentication, secure, computer-generated time-stamped audit trails, controls that link each signature to its record and meaning, and the ability to generate accurate, complete copies for inspection and retention. Cognidox’s controls and audit logs are designed to meet those expectations in a closed system.

Do we need to validate the e-signature system (CSV/CSA)?

Yes. Part 11 requires using validated software for regulated records. We provide vendor documentation and support risk-based CSV/CSA so you can validate proportionately and maintain validation through change.

How do we produce human-readable copies for auditors?

Part 11 requires accurate, complete copies of electronic records on request. Cognidox can generate readable, exportable copies with embedded approval manifests and audit details so inspectors can verify identity, intent, date/time, and record version.