Supplier Quality
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
Document Management
Control, track and manage documents required for compliance with ISO 9001 & ISO 14001
Product & Raw Material Specifications
Collaborate on drawings, work instructions, material & process specs, test specs, regulatory requirements and other docs
Electronic Batch Records
Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.
Approval Workflows
Implement approval workflows within the QMS with electronic signatures
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
Risk Management
Identify and mitigate risks during device design and production stages in compliance with ISO 14971.
Risk Management
Identify and mitigate risks during product design and production stages
Complaint Handling
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Regulatory & Compliance
Ensure adherence to relevant regulatory requirements, such as ISO 9001, ISO 14001 and other applicable standards.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
First Article Inspection
Validate that product design and production processes produce items meeting specified design requirements.
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Integration & Collaboration
Integrate with other systems and tools, such as ERP systems, CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.
Revision Control
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Performance Metrics and Reporting
Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Change Control
Controlled management of changes to device design or production process with proper review and approval.
Audit Management
Plan, schedule, and conduct internal, layered and external audits for compliance verification.