Track and ensure employee training on procedures, regulations, and device handling.
Design Master Record
Manage device specifications, manufacturing processes, labelling, packaging and quality control procedures.
Document Management
Control, track and manage documents required for compliance with FDA Part 820 and ISO 13485.
Revision Control
Ensure devices meet predefined specifications, with proper documentation, review, and approval of changes & revisions by the right people.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Audit Management
Plan, schedule, and conduct internal, layered and external audits for compliance verification.
Approval Workflows
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
First Article Inspection
Validate that product design and production processes produce items meeting specified design requirements.
Design History File
Keep a history of all design inputs, outputs, verification/validation activities & risk management.
Product Lifecycle Management
Manage device's lifecycle stages from design through obsolescence with a focus on quality control.
Electronic Batch Records
Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.
Regulatory & Compliance
Ensure adherence to relevant regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, MDR (Medical Device Regulation), and other applicable standards.
Change Control
Controlled management of changes to device design or production process with proper review and approval.
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Supplier Quality
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
Complaint Handling
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Performance Metrics and Reporting
Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.
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.