- Impact Assessment: Evaluate the potential impact of the issue on processes, products, regulatory compliance, and other aspects of the organization. This helps prioritize corrective actions and determine the level of urgency.
- Risk Assessment: Assess the risks associated with the issue, quantifying the likelihood and severity of potential consequences. This informs decision-making and aids in prioritizing mitigation efforts.
- Notification and Approval: Automated notifications are sent to relevant stakeholders for review and approval, ensuring transparency and accountability throughout the investigation process.
- Corrective and Preventive Actions (CAPA): Once the root cause is identified, our module supports the creation and tracking of corrective and preventive actions to address the issue and prevent recurrence.
- Compliance Tracking: Ensure all investigation activities adhere to industry regulations and internal policies, providing templates and workflows aligned with regulatory requirements.
- Collaboration and Communication: Facilitate effective communication among stakeholders involved in the investigation process, ensuring timely resolution and alignment on action plans.
- Documentation Storage: Centralize all documentation related to investigations within the QMS software, promoting data integrity, accessibility, and compliance with auditing requirements.
- Reporting and Analytics: : Gain insights into the status of ongoing investigations, corrective actions, and preventive measures through real-time reports and analytics tools. Identify trends and patterns to drive continuous improvement efforts.
- Audit Trail: Maintain a detailed audit trail of all actions and changes made within the Investigation Module, ensuring transparency and compliance during regulatory audits and inspections.
INVESTIGATION
Introducing Arizona TrackQS (QMS) Software's Investigation Module – Your Comprehensive Solution for Efficient Investigations and Issue Resolution.
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This vital component is designed to assist organizations in effectively managing and resolving issues, incidents, or deviations within their processes, products, or services. Here's a detailed overview of the functionalities within our Investigation Module:
- Issue Initiation: : Authorized users can easily initiate investigations for various issues, ranging from process deviations to product defects or regulatory compliance concerns.
- Workflow Automation: Our module automates the investigation workflow, ensuring tasks are assigned, deadlines are set, and progress is tracked seamlessly. This streamlines the investigation process and expedites resolution.
- Documentation Management: Users can attach relevant documentation and supporting information to investigations, facilitating a thorough understanding of the issue and aiding in decision-making.
- Root Cause Analysis: Conduct comprehensive root cause analysis to identify the underlying reasons behind the issue. Integrated tools and methodologies assist in this process, ensuring effective problem-solving.
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