Document management involves organizing, controlling, and maintaining critical documents and records throughout the product lifecycle. It ensures that all documentation is accurate, version-controlled, and readily accessible to meet compliance and quality standards.

Evaluating, documenting, and approving modifications to a product’s design, documentation, or processes. It ensures every change is controlled, traceable, and compliant with regulatory requirements, including support for Part 11 compliant electronic signatures.

Ensures that all personnel are proficient and compliant with regulatory and operational standards. It schedules and tracks training sessions, certifications, and continuing education, maintaining detailed records to support audit readiness and continuous improvement.

Systematically manages and traces design activities—from capturing design input requirements and specifications to executing test cases and protocols, culminating in comprehensive reports. This process is documented in a design history file, ensuring robust design control and full traceability to meet regulatory standards and quality assurance throughout the product lifecycle.

Supports a robust risk management process that complies with ISO 14971. Systematically identifies, evaluates, and mitigates potential hazards throughout the product development lifecycle.

Include processes like CAPA (Corrective and Preventive Action), NC (Non-Conformance), and SCAR (Supplier Corrective Action Request). These events help organizations detect, investigate, and resolve quality issues, ensuring continuous improvement and regulatory compliance throughout the product lifecycle.

Plans and captures internal audit activities while also supporting external audits. The system streamlines scheduling, documentation, and reporting, ensuring that all audit findings are tracked and resolved, which strengthens compliance and continuous improvement efforts.

Qualifies, monitors, and manages suppliers to ensure they meet quality and regulatory standards. It integrates supplier data, tracks performance, and facilitates timely corrective actions, ensuring a robust and compliant supply chain.

Organizes, tracks, and maintains the bill of materials throughout the product lifecycle. It ensures accurate revision control and seamless change management, providing full traceability to support manufacturing efficiency, compliance, and quality standards.

Tracks and maintains critical equipment used in production and testing. It supports scheduled maintenance, calibrations, and service, ensuring optimal performance, reliability, and regulatory compliance.

Manages critical production records, including the Device Master Record (DMR) and Device History Record (DHR). It ensures every manufacturing step is documented, compliant, and traceable, supporting robust quality control and audit readiness.

Integrates robust Electronic Data Capture (EDC) capabilities to streamline clinical data collection, monitoring, and analysis. This ensures real-time, accurate data capture, enhances study oversight, and maintains regulatory compliance throughout the clinical trial lifecycle.

Manages both formative and summative usability studies, streamlining study design, data capture, and analysis. It ensures comprehensive evaluation of user interactions, enabling effective identification and mitigation of usability risks in compliance with regulatory guidelines.

Streamlines FDA regulatory submissions and technical documentation preparation. Continuously monitors updates to standards, guidance, and regulations. This proactive approach ensures ongoing compliance and readiness for audits throughout the product lifecycle.