Validation Compliance
Novo Compliance’s team supports our clients and life science companies achieve and maintain global validation and compliance standards across traditional and emerging technologies. Novo Compliance’s Computer System Validation (CSV), Computer Software Assurance (CSA), AI & ML-enabled platforms provide our clients and the life sciences ecosystem the bespoke services translating complex regulatory frameworks including the FDAs 21 CFR Part 11, ISPEs GAMP 5, ISO 13485, and IEC 62304 into comprehensive, compliant and sustainable validation strategies aligning with global GxP and digital health technologies. Our regulatory support validating cloud-based systems, adaptive algorithms, and modular platforms, Novo Compliance’s team ensures audit readiness, data integrity, and scalable compliance across clinical, manufacturing, and post-market domains.
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