Arizona Automation & Technology

CHANGE CONTROL

Introducing Arizona TrackQS (QMS) Software's Change Control Module – a pivotal tool that empowers organizations to manage and control changes to their processes, products, documents, or systems in a structured and compliant manner. Our Change Management module is aligned with FDA, MHRA, and ICH Q10 guidelines, providing organizations with a robust system to manage change effectively. From initiation to implementation, our software ensures that changes are evaluated, approved, and implemented in a timely and compliant manner.

Here's a comprehensive breakdown of its functionalities:

Change Control Initiation: Authorized users can initiate change requests encompassing various changes, including process modifications, product design alterations, document updates, and system changes.
Workflow Automation: The module automates workflows for review, approval, and execution, ensuring that change requests are routed to the appropriate individuals or departments based on predefined criteria and roles.
Documentation: Users can attach relevant documentation and supporting information to change requests, including impact assessments, risk analyses, and justifications, facilitating informed decision-making.
Impact Assessment: Impact Assessment: Evaluate the potential impact of proposed changes on processes, products, regulatory compliance, and other aspects of the business.
Risk Assessment: Facilitate risk assessment by providing tools and methodologies to evaluate the likelihood and severity of potential issues associated with the change.

Notification and Approval: Users can attach relevant documentation and supporting information to change requests, including impact assessments, risk analyses, and justifications, facilitating informed decision-making.
Change Implementation: Manage the implementation process, updating documents, revising processes, or making system changes as necessary.
Verification and Validation: Track verification and validation processes to ensure changes are implemented correctly and effectively, particularly in regulated industries.
Compliance Tracking: Ensure adherence to industry regulations and internal policies, providing templates and workflows aligned with standards such as Good Manufacturing Practices (GMP) or ISO.
Document Management: Centralize all change-related documentation within the QMS software, promoting data integrity and accessibility for compliance and auditing purposes.
Reporting and Analytics: Gain real-time visibility into change requests, approvals, and implementations through reports and dashboards. Analytics tools identify trends and patterns, aiding decision-making and continuous improvement efforts.
Audit Trail: Detailed audit trails capture all actions and changes within the module, critical for demonstrating compliance during regulatory audits and inspections.
Integration: Seamlessly integrate with other QMS modules such as Document Management, CAPA (Corrective and Preventive Actions), and Training Management to ensure interconnectedness and coherence in quality processes.