CAPAs and
Non-conformance

Identify and resolve quality events, prevent recurrence,
and drive continuous improvement

CAPA process Flow 110723

Companies need a documented and effective non-conformance and CAPA process to identify and investigate quality events:

Trigger corrective actions to address the root cause of a problem
Prevent similar issues from occurring in the future
Maintain compliance with ISO 13485:2016 and FDA regulations

But without a right-sized approach to the non-conformance process, developers risk being swamped with Corrective Action reports or not triggering CAPAs enough to keep control of quality.

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 provides NCR and CAPA reporting templates and workflows that can meet rigorous ISO standards and FDA regulations while keeping your process Lean, flexible and effective.

Easy-to-configure forms and workflows for complaints, non-conformances and CAPAs
Eliminate defects and stop recurrence through effective investigation and analysis
Assess risk and categorise NCRs to trigger CAPA investigations when appropriate
Identify and document non-critical OFI (Opportunities for Improvement) - to help optimise processes in the future
Automate processes and reminders to keep key stakeholders in the loop throughout investigations
Ensure fixes are verified and followed up for effectiveness
Capture essential data to analyse quality trends and drive continuous improvement
Enable proactive monitoring of quality to prevent product and process failures
Ensure complete traceability of every quality event

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

e-Signatures

Integrate FDA and ISO 13485-compliant e-signatures into your eQMS

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

CAPAs and Non-conformance

How does the Cognidox CAPA module actually work?

It’s a form-driven workflow with required sections: problem description → containment → root-cause analysis → corrective actions → preventive actions → closure & effectiveness check. Each section is assigned to the right role, time-stamped, and logged. Final closure is restricted to a competent person with e-sign-off.

What makes the system both configurable and controlled?

Every workflow is powered by JSON form definitions. You can add/remove sections, rename fields to your terminology, or introduce new required data—without breaking governance. Routing rules, mandatory fields, and approval gates ensure changes increase control rather than reduce it.

Can work be handed off between people without losing traceability?

Yes. You can route a record step-by-step (e.g., author enters problem description → colleague records containment → QA performs RCA). Each hand-off is captured with user, date/time, and status, maintaining a complete audit trail.

How are dates, signatures, and audit trails handled?

Each time a user edits a CAPA section via the form and saves, Cognidox creates a new draft revision with a UTC timestamp, the user’s identity, and the section(s) changed. Final sign-off happens only at closure, by a competent person via role-based approval; locking the record with version and approver context.

What reporting do we get from CAPA data?

Because submissions are stored as structured JSON, every field is reportable: open CAPAs, all-time CAPAs, cycle time by site/product/cause, overdue actions, effectiveness pass/fail, root-cause Pareto, and more. Export to Excel (or BI tools) for deeper analysis.

What’s your approach to NCR (Nonconformities)?

NCRs use the same controlled form model. You capture product vs service classification, detailed description, disposition, and—if applicable—Concession (use-as-is) with status tracking. The form can prompt: “Has a related CAPA or OFI been raised?” to keep the loop closed. The NCR can then be linked to the resulting CAPA or OFI.

Can we follow a visual process flow?

Yes. Users are guided by a visual process flow that mirrors your SOP, with clear stage names, assignees, and exit criteria. It reduces training time and drives consistent execution.

Who can close a CAPA or NCR?

Only users you designate as competent for that process can perform final review & closure. Competence can be tied to role, training completion, or manager approval—your choice.

Can we start quickly and still tailor later?

Yes. You get proven templates that work out of the box (we use them ourselves). When you’re ready, clone and adapt: add a section, change terminology, or introduce extra approvals—no re-platforming.

Is the workflow configurable?

Stages, fields, and approvals are configurable to your SOP while preserving compliant audit trails.