Lifecycle Management
Manage end-to-end change lifecycle by integrating disjoint processes and boost efficiency.
Helyx Quality Management System
Consistent and Reliable QMS for Life Sciences
HELYX QUALITY MANAGEMENT SYSTEM
Integrated quality processes for Change Controls, Incidents, Deviations, and CAPAs ensuring reliability while maintaining quality and consistency with a modern compliance-driven system.
Change Controls
Efficiently manage quality processes for Change Controls throughout their lifecycle. Ensure reliability while maintaining quality and compliance.
Automated Workflows
Streamline activities, reviews, approvals, and notifications with automated routing to the right stakeholders.
Impact Assessment
Document overall impact for straightforward changes. Assess, document, and track detailed impact for complex changes.
Implementation Planning
Achieve success by engineering complex changes into multiple actionable changes, track progress and completion.
Timeline Management
Enforce accountability and flexibility by tracking timelines with the oversight for any slippage with extension requests.
Review & Sign-offs
Ensure every change is controlled, compliant, and traceable with electronic approvals from initiation thru closure.
Monitor Effectiveness
Monitor effectiveness of complex changes post implementation to assess user adoptability and efficiency.
Reports & Analytics
Predictive insights into Change Controls aimed at ensuring quality, efficiency, and improvement.
Incidents
Report and triage an incident to determine if a formal deviation is required to avoid unnecessary complications during audit situations, ensuring quality metrics are not skewed.
Incidents Triage
Rapid intake and initial assessment of events to determine whether the issue requires formal deviation.
Automated Workflows
Streamline review, decision, and notifications with automated routing to the right stakeholders.
Evaluate Incident
Assess reported incidents with documented justification for the decision whether a deviation is required or not.
Formal Deviation
Automatically initiate a deviation based on the reported incident, if the evaluation outcome warrants a formal deviation.
Deviations
Streamline management of all deviations from approved processes. Robust investigation process to determine impact, root cause and implement CAPAs to prevent recurrence.
Lifecycle Management
Manage end-to-end deviation lifecycle by integrating disjoint processes and boost efficiency.
Automated Workflows
Streamline activities, reviews, approvals, and notifications with automated routing to the right stakeholders.
Investigation
Conduct a structured investigation to identify root cause, assess impact, and document findings.
CAPA Integration
Connects deviations to CAPAs, enabling seamless initiation, end-to-end traceability, and consistent resolution.
Timeline Management
Enforce accountability and flexibility by tracking timelines with the oversight for any slippage with extension requests.
Review & Sign-offs
Ensure every deviation is controlled, compliant, and traceable with electronic approvals from initiation thru closure.
Reports & Analytics
Predictive insights into Deviations aimed at ensuring quality, efficiency, and improvement.
CAPAs
Improve processes by identifying and eliminating root causes of non-conformities, ensuring effectiveness in resolving existing issues and mitigating risk of recurrence.
Lifecycle Management
Manage end-to-end CAPA lifecycle by integrating disjoint processes and boost efficiency.
Automated Workflows
Streamline activities, reviews, approvals, and notifications with automated routing to the right stakeholders.
Deviation & Change Control Integration
Seamlessly links deviations and change controls to CAPAs, ensuring traceability and consistent root cause resolution.
Monitor Effectiveness
Monitor and identify any gaps to ensure CAPAs are working as intended, address root causes, and prevent recurrence.
Timeline Management
Enforce accountability and flexibility by tracking timelines with the oversight for any slippage with extension requests.
Review & Sign-offs
Ensure every CAPA is controlled, compliant, and traceable with electronic approvals from initiation thru closure.
Reports & Analytics
Predictive insights into CAPAs aimed at ensuring quality, efficiency, and improvement.
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