Establish traceability between requirements, tests, and design elements, ensuring comprehensive coverage and compliance with regulatory standards.

Manage validation documentation throughout the product development lifecycle, ensuring compliance with regulatory requirements.

Ensure compliance and timely regulatory submissions through streamlined document preparation and submission processes.

Integrate with other systems and tools, such as ERP systems, CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.

Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.

Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.

Ensure adherence with regulatory requirements, manage compliance documentation, and track regulatory changes

Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.

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

Plan, schedule, and conduct internal, external, GMP audits, document findings, track action items, and ensure timely closure.

Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation against each ingredient.

Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.

Digitally control batch releases, record batch production data, ensuring traceability and adherence to product & raw material sepcifications.

Implement a systematic approach to identify, assess, and manage risks associated with cosmetic operations.

Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.

Manage formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.

Centralized storage, version control, and automated workflows to comply with 21 CFR Part 700, EU Cosmetics Regulation (EC No 1223/2009) and ISO 22716.