Issues and CAPA

Q-Pulse provides a centralised corporate reporting system to manage the complete CA/PA lifecycle across an organisation. It provides the ability to solve problems quickly and thoroughly to minimise the impact and lessen the chance of re-occurrence.

The CA/PA process is suitable for any problem type and uses pre-defined or standard reports to provide a repeatable process to capture and manage information effectively.

Q-Pulse provides a closed-loop CA/PA system where a range of problem solving methodologies including 8D, 5W, 6M, etc can be deployed to assist in the investigation process.

The integrated nature of the entire management system provides a holistic assessment of oversight and detailed visibility of any exposure. From here, progress to date can be assessed and accountability across the entire CA/PA process is available at your fingertips.

The key to any CA/PA is reliable and accurate data and Q-Pulse provides Wizards and Templates to enable rapid data entry, providing links to other IT systems to cross reference, authenticate and pre-populate data capture. The entire CA/PA process is managed, with efficient tools like MindGenius used to aid root cause investigation and to help determine action plan, timescales and assignation of tasks.

The powerful Q-Pulse Workflow Engine is used to auto-route notifications, reminders, escalations, approvals and closure saving hours of effort chasing people and signatures. Action dates are tracked to conclusion and any actions overdue are dealt with accordingly.

Clever and easy to use, the Trending and Analysis capability provides insightful reports and metrics and an in-depth Report Designer is available to draw out any information required.

Overall Q-Pulse promotes consistent processes to facilitate compliance, reduce risk of lost or incomplete data and reduce risk of repeat issues.

With Q-Pulse, CA/PA management is more efficient through improved reporting and integration. Integration, where appropriate with other management systems to connect and leverage information within the organisation, provides robust systems and lower operational costs.

For organisations needing 21 CFR Reporting Q-Pulse provides electronic signature and Audit Trails compliant with those needs.

Q-Pulse CAPA Management - the complete solution.  

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