Enterprise Corrective and Preventive Action

Build an enterprise CAPA management system from the ground up using the Microsoft® 365 platform. Allow users across the organisation and supply chain to record incidents, deviations or non-conformances and to initiate corrective and preventive actions to resolve them.

Ensure an efficient and effective CAPA process which will guide the resolution of issues quickly and prevent their recurrence – safeguarding your organization’s future and securing compliance with industry and regulatory requirements.

Provide an easy-to-use system designed to effectively manage the corrective and preventive action process and integrate it with other quality processes, such as change control, audit, and customer complaints.

Use easily configurable forms and workflows and allow users to benefit from a familiar interface and to leverage existing investments in collaboration software.

Automate the management of the entire CAPA process, from initiation to investigation through action to review and closure.

Leverage Power BI based, configurable reporting capabilities to provide real-time visibility and to identify areas that need improvement and where regulatory compliance risk exists.

Build Systems to

  • Track issues and root causes

  • Reduce CAPA cycle time and costs by increasing efficiencies.

  • Provide management visibility into quality and compliance.

  • Configure workflow to match current processes.

  • Streamline the CAPA lifecycle from initiation to closure.

  • Fulfill ISO9001, 13485, 21CFR Part 820, 210 & 211.

  • Improve communication and teamwork on quality issues.