We provide comprehensive equipment qualification services including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Our team develops and executes protocols, implements risk-based validation approaches, and ensures your equipment meets regulatory standards. We also offer requalification strategies and gap assessments to maintain ongoing compliance.
Our remediation services address data integrity, audit support, and regulatory inspection readiness. We help update legacy system documentation, close CAPAs, and remediate quality systems to ensure your organization is always inspection-ready and compliant with the latest standards.
We offer engineering support for commissioning and qualification (C&Q), project-based contractor deployment, FAT/SAT coordination, and vendor documentation reviews. This includes review and optimization of preventive maintenance and calibration procedures as needed. Our team ensures seamless integration and validation of new and existing equipment and systems.
Our QA services include SOP development and revision, QA/QC audit support, change control, deviation investigation, and validation master planning (VMP). We help you build and maintain robust quality systems that support compliance and operational excellence.