Control, track and manage documents required for compliance with IATF 16949, ISO 9001
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Product & Raw Material Specifications
Collaborate on drawings, work instructions, material & process specs, test specs, regulatory requirements and other docs
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Identify and mitigate risks during product design and production stages
Electronic Batch Records
Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.
Controlled management of changes to device design or production process with proper review and approval.
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
Plan, schedule, and conduct internal, layered and external audits for compliance verification.
APQP (Advanced Product Quality Planning)
Streamline your development process with APQP for enhanced product planning, risk assessment, and process control.
Manage your production part approval process (PPAP) with our software for seamless documentation, validation, and supplier collaboration."
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
First Article Inspection
Validate that product design and production processes produce items meeting specified design requirements.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
Regulatory & Compliance
Ensure adherence to relevant regulatory requirements, such as IATF 16949
Performance Metrics and Reporting
Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
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.
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.