GXP Audits

GxP refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications.

The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and others.

GXP Audits

GxP refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications.

The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and others.

Life sciences organizations must implement product-specific requirements based on the following:
Type of products and the country in which the products are distributed
leading to compliance with local regulations and adherence to specific product standards.

Ensuring Compliance and Validation in GxP Systems:

Development, Operation, and Audit Services

When pharmaceutical or life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.

Our GXP audit services focus on the compliance to the applicable guidance and local requirements. Individual area experts are involved in the review as per the scope of audit (GCP, GMP, GLP and /or GDP).

GLP
Audits

GCP
Audits

GMP
Audits

GDP
Audits

GVP
Audits

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GCP Audits
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GMP Audits