GxP Software Validation, CSA & 21 CFR Part 11 Consulting
Risk-based GxP software validation and computer software assurance for regulated organizations and SaaS providers working under 21 CFR Part 11, EU Annex 11 and GAMP 5 expectations.
When This Matters
For regulated organizations implementing new systems, replacing legacy systems, introducing AI-enabled workflows, or qualifying SaaS platforms used to create, modify, approve, store or report GxP records.
What We Evaluate
Intended use, process risk, data integrity, electronic records and signatures, audit trails, access controls, supplier responsibilities, testing strategy, traceability, infrastructure dependencies, change control and lifecycle governance.
What You Receive
A risk-based validation strategy and evidence roadmap aligned to FDA CSA principles, 21 CFR Part 11, Annex 11 and practical GAMP 5 expectations where applicable.
Evidence That Regulated Customers Can Evaluate
Support is led directly by a senior Quality advisor with hands-on experience in validation, computerized systems, data integrity, electronic records, audit trails and lifecycle governance. For SaaS and AI-enabled products, the work also addresses the boundary between supplier evidence and the regulated customer’s own validation responsibilities.
Review the regulated SaaS readiness case study or explore our work with GxP SaaS, AI and digital-system companies.