GxP Compliance specializes in:
IT Infrastructure Qualification
System Development & IT Compliance Audits
IT Infrastructure Qualification
IT Infrastructure Qualification – ensuring your infrastructure is properly documented, tested, and maintained in a controlled state.
Computer System Validation
System Development & IT Compliance Audits
IT Infrastructure Qualification
Computer System Validation (CSV) & Computer Software Assurance (CSA) – implementing risk-based approaches to validate new systems and maintain compliance for existing platforms.
AI System Validation
System Development & IT Compliance Audits
System Development & IT Compliance Audits
AI System Validation – defining strategies for AI-based tools and machine learning models to ensure they meet regulatory expectations and data integrity requirements.
System Development & IT Compliance Audits
System Development & IT Compliance Audits
System Development & IT Compliance Audits
System Development & IT Compliance Audits – establishing or refining SDLC processes, evaluating validation and qualification programs, and identifying gaps in existing compliance frameworks.
Our Expertise
With decades of experience dating back to the initial draft guidance of
21 CFR Part 11 in 1997, our team brings deep regulatory and industry expertise. We provide scalable, tailored solutions to meet the needs of any organization, whether you’re establishing compliance controls for the first time or optimizing a mature program.