Qval Consulting

Strategic Consulting Services for Computer System Validation (CSV) & Data Integrity for Life Sciences Qval Consulting partners with Pharmaceutical, Biotech, and Medical Device companies to navigate the complexities of digital compliance. We bridge the gap between strict regulatory requirements (FDA/EMA) and operational efficiency. We specialize in moving organizations from traditional, documentation-heavy validation to modern, risk-based Computer Software Assurance (CSA). Our Core Services: CSV & CSA Strategy: Full lifecycle validation for GxP systems (ERP, LIMS, MES, QMS, AI/ML) aligned with GAMP5 (2nd Ed). Data Integrity (DI): Comprehensive gap assessments, remediation plans, and ALCOA+ governance frameworks. Regulatory Compliance: Audit-readiness for 21 CFR Part 11, EU Annex 11, and MHRA guidelines. Auditing: Third-party vendor audits and internal mock inspections to identify risks before regulators do. Training: Upskilling teams on the latest industry standards and risk-based methodologies. We don't just "check the box." We implement risk based quality frameworks that ensure your data is accurate, secure, and audit-ready without slowing down operations and innovation. Contact us to discuss your validation roadmap: