What Is GxP Compliance?
GxP is a collective term for 'Good Practice' regulations and quality guidelines applicable to the life sciences industry. The 'x' represents the specific field: GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GDP (Good Distribution Practice), and others.
GxP regulations ensure that products are safe, meet their intended use, and adhere to quality processes throughout their lifecycle.
When AI systems are used in GxP-regulated activities — manufacturing quality control, laboratory testing, clinical trial management, or distribution — those systems must operate within GxP-compliant frameworks. This includes validated computer systems, documented change control, training records, deviation management, and complete traceability.
BioCompute Connection
BioCompute's Compliance Manager provides GxP-aligned review workflows, role-based approvals, and cross-team coordination that map directly to GxP quality management requirements.
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