GxP Compliance & Auditing

GxP compliance ensures that regulated activities are performed in accordance with applicable FDA regulations and industry standards. GxP compliance and auditing focus on maintaining control across clinical, manufacturing, laboratory, and safety environments while supporting consistent execution.

Compliance programs typically encompass policies, procedures, training, and oversight mechanisms designed to protect data integrity and patient safety. Auditing plays a critical role in identifying gaps, assessing risk, and confirming that quality systems are functioning as intended.

Effective GxP compliance programs help organizations identify issues early and address them before they escalate into regulatory findings.

GxP compliance and auditing activities commonly include:

• Internal GxP audits and gap assessments

• Vendor and CRO audits

• Compliance program evaluation

• Risk-based audit planning

• CAPA identification and follow-up