Mastercontrol has announced the availability of its Capa Pathwise software solution, developed in conjunction with consulting and training firm Pathwise.
Mastercontrol Capa Pathwise is a holistic software solution designed to automate and effectively manage the corrective and preventative action (Capa) process and integrate it with other quality processes, such as change control, auditing, training, non-conformance resolution, and intelligence-mining from customer complaints.
Mastercontrol Capa Pathwise propagates the Capa process throughout the entire organisation.
For example, the resolution of a Capa could trigger change control in engineering, editing an SOP in production, and retraining employees through human resources.
This connectivity also means that a Capa can be launched from any valid source such as customer complaints, non-conformance reports, vendor audits and so on to further streamline the process.
The system allows users to evaluate issues based on impact and frequency and provides clear direction as to what preventative and corrective actions should - or should not - be taken.
The routing, delivery, escalation, and approval of each Capa - and all the related documents - is provided through a centralised and interconnected repository.
This makes it possible for key players throughout the organisation to collaborate and apply analytical thinking to each step of the Capa process.
The Mastercontrol Capa Pathwise solution also automatically tracks all routing information and revision data entered into an electronic form, allowing the process owner to identify bottlenecks and monitor progress.
The system makes it easy to generate reports without IT involvement and uses the built-in Pathwise Gateway process to provide unparalleled risk assessment capabilities.
The Gateway process provides users with a step-by-step guide within a risk assessment, based on frequency and impact that reveals whether or not a Capa issue is even warranted.
This all takes place long before any preventive action or corrective action resources are committed.
Capa Pathwise compares null hypothesis scenarios to come up with clues that lead to the most likely causes that can then be tested to determine the actual root cause.
Users are walked through the process for more efficient and effective root cause investigation.
It automates all Capa tasks, including routing, notification, follow-up, escalation, and approval.
Automation helps sustain compliance by simplifying processes.
The system connects the Capa process with other quality processes for a 'closed-loop' approach to management.
Other features and benefits of the Mastercontrol Capa Pathwise solution include: robust analytics and reporting capabilities; Part 11-compliant features; web-based platform; integration with existing repositories; form-to-form launching; anonymous internet access; seamless integration with the training process; continuous validation; and expert technical support and consultation.
