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System Audits, GXP Audits & FDA Rediness

System audits follow the FDA inspection program of Quality System Inspection Technique (QSIT), which is a process to review compliance against the quality systems regulations and related regulations. GXP audits include GMP, GLP, and GCP areas.

Compliance Strategies, Inc. has experience in both system audits, for cause audits for areas covering all regulations, and project-related audits.

It is essential for companies to understand and implement all regulatory requirements. In order to ensure successful regulatory inspections, companies must have a plan on how they prepare. This preparation should include personnel, documents, and management. Employing an outside resource to review systems and procedures more closely mimics a regulatory agency inspection. Mock pre-approval inspections (PAI) have tremendous value in that it focuses the project management team on aspects that might be overlooked by an internal audit alone. As more firms engage resources across the globe, such as contract manufacturing or licensing partners, it is key to establish a harmonized framework to outline the steps necessary for the success of the project.

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