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