Centralized storage, version control, and automated workflows to comply with 21 CFR Part 700, EU Cosmetics Regulation (EC No 1223/2009) and ISO 22716.
Recipe & Formulation Management
Manage formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
Product & Raw Material Specifications
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.
Implement a systematic approach to identify, assess, and manage risks associated with cosmetic operations.
Electronic Batch Records
Digitally control batch releases, record batch production data, ensuring traceability and adherence to product & raw material sepcifications.
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 against each ingredient.
Plan, schedule, and conduct internal, external, GMP audits, document findings, track action items, and ensure timely closure.
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
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 with regulatory requirements, manage compliance documentation, and track regulatory changes
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.
Ensure compliance and timely regulatory submissions through streamlined document preparation and submission processes.
Validation & Verification
Manage validation documentation throughout the product development lifecycle, ensuring compliance with regulatory requirements.
Establish traceability between requirements, tests, and design elements, ensuring comprehensive coverage and compliance with regulatory standards.