We offer comprehensive CQV services for the pharmaceutical, biotech, and other regulated industries to ensure compliance and operational excellence. Our experts develop customized validation solutions to help you meet and exceed regulatory standards.
- Computer System Validation & Assurance (CSV/CSA): ensure your systems are compliant, reliable, and fit for their intended use. It covers risk-based validation, documentation, testing, and ongoing assurance activities, including change control, data integrity, and periodic reviews.
- Audits & Assessments: evaluate compliance, system integrity, and process effectiveness. It covers gap assessments, internal and supplier audits, risk-based evaluations, and remediation guidance aligned with applicable GxP regulations, ISO standards, and other regulatory bodies.
- Vendor Qualification Program: evaluate and manage suppliers based on risk, performance, and reliability. The service includes vendor risk assessment, due diligence reviews, capability and security evaluations, onboarding criteria, and ongoing performance monitoring.
- Quality Management System (QMS) Implementation & Improvements: enhance consistency, efficiency, and accountability across your organization. It includes process design, documentation development, risk management, performance metrics, and continuous improvement initiatives.
- ISO Implementation & Improvements (9001/13485/14001/14644/27001): we assist your organization in achieving certification across all ISO standards, guaranteeing full compliance with current international requirements and best practices. It involves creating and executing quality management systems customized to your organization’s specific needs, overseeing internal audits, and thoroughly preparing for external certification audits.
- Equipment Commission, Qualification & Validation (CQV): provides structured support to ensure systems are installed correctly, operate as intended, and consistently perform to requirements. It includes requirements definition, testing, documentation, issue resolution, and performance verification.
