Compliance

Delivering end-to-end software verification to ensure reliability, data integrity, and regulatory compliance across all development phases.

Executing Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for manufacturing and laboratory equipment to ensure consistent product quality.

Providing validation services aligned with FDA, EMA, and WHO guidelines for both regulated (GxP) and non-regulated (Non-GxP) environments.

Verifying controlled environments through particle count testing, airflow visualization, and temperature/humidity mapping for GMP compliance.

Performing comprehensive validation lifecycle activities—planning, testing, documentation, and maintenance—to meet 21 CFR Part 11 and Annex 11 standards.

Conducting validated data transfer processes to ensure accuracy, completeness, and traceability during system upgrades or platform transitions.

Implementing and validating QMS platforms to streamline quality processes, CAPA management, and compliance reporting.

Delivering end-to-end software verification to ensure reliability, data integrity, and regulatory compliance across all development phases.