Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Document Management_
Control, track and manage documents required for compliance with SQF, BRC & CFR Part 111
Approval Workflows_
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
Supplier Quality_
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
Recipe & Formulation Management_
Manage recipes, formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
Calibration & Maintenance_
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Performance Metrics and Reporting_
Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.
Electronic Batch Records_
Digitally control batch releases, record batch production data, ensuring traceability and adherence to product sepcifications.
Risk Management_
Implement a systematic approach to identify, assess, and manage risks associated with food processing operations.
CAPAs and NCs_
Document, track and correct non-conformities & CAPAs to meet food safety standards like HACCP and ISO 22000.
Regulatory & Compliance_
Ensure adherence to food safety regulations and standards, such as HACCP (Hazard Analysis and Critical Control Points), GMP (Good Manufacturing Practices), and applicable local and international requirements.
Security & Access Controls_
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Change Control_
Manage changes in recipes, processes, or equipment to ensure consistent food quality.
Training_
Ensure employees are trained on food safety practices and quality procedures, including when controlled docs are revised.
FMEA_
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
Product & Raw Material Specifications_
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.
Complaint Handling_
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Audit Management_
Plan, schedule, and conduct internal, external, GMP audits, document findings, track action items, and ensure timely closure.
EH&S
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
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.