At GxP Compliance, we are dedicated to providing top-notch consulting services to our clients. Our mission is to help businesses of all sizes reach their full potential through the use of technology.
IT Infrastructure Qualification – ensuring your infrastructure is properly documented, tested, and maintained in a controlled state.
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 – 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 – establishing or refining SDLC processes, evaluating validation and qualification programs, and identifying gaps in existing compliance frameworks.
With decades of experience dating back to the initial draft guidance of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.
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