Control, track and manage documents required for compliance with SQF, BRC & 21 CFR Part 111
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
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.
Plan, schedule, and conduct internal, external, GMP audits, document findings, track action items, and ensure timely closure.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Electronic Batch Records
Digitally control batch releases, record batch production data, ensuring traceability and adherence to product & raw material sepcifications.
Manage changes in recipes, processes, or equipment to ensure consistent food quality.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Implement a systematic approach to identify, assess, and manage risks associated with food processing operations.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
Recipe & Formulation Management
Manage recipes, formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
CAPAs and NCs
Document, track and correct non-conformities & CAPAs to meet safety standards like HACCPP, ISO 22000 and 21 CFR Part 111.
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.
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Product & Raw Material Specifications
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.