GxP is a collective term for Good Practice regulations — including GMP, GLP, and GCP — that govern pharmaceutical manufacturing, research, and clinical trials. Any IT system that captures, processes, or stores data that impacts product quality or patient safety must meet GxP requirements, including audit trails, access controls, and validated functionality.

Yes. Migrating a validated system to AWS, Azure, or Google Cloud constitutes a significant change and requires requalification.

CSA is FDA’s 2022 guidance that shifts away from documentation-heavy Computer System Validation toward a risk-based, critical thinking approach. Instead of generating voluminous test scripts for every function, CSA focuses effort on high-risk, patient-impacting feature

Inspectors can — and do — examine validation records, audit trails, access logs, backup and recovery procedures, and change control histories. Gaps in any of these areas can result in observations, warning letters, or import alerts.

We implement Zero Trust architecture, endpoint protection, and incident response plans that are aligned to both NIST and FDA data integrity guidance, ensuring your security posture doesn’t create compliance exposure.

No — in fact, it’s the best time. Building compliant infrastructure from the start is significantly less expensive than remediating systems later.

Yes—that’s precisely what differentiates ITGxP. We don’t hand off between a technical team and a compliance team. Our engineers understand validation requirements, and our quality specialists understand the underlying technology. One firm, one engagement, one accountable deliverable.

e work exclusively within pharmaceutical, biotech, medical device, CDMO, and CRO environments — from pre-IND startups building their first validated system to commercial manufacturers managing complex, multi-site GxP IT estates. Our services are scoped to match your regulatory stage and risk profile.