Gap Analysis for CROs and Laboratories: GLP/GCLP
Embark on the journey to GLP/GCLP Accreditation or Compliance with confidence. Our specialized Gap Analysis service is designed to meticulously prepare your organization for its first accreditation or compliance assessment. Through a comprehensive and detailed analysis, we identify existing gaps and provide targeted recommendations for corrective actions, elevating your company's quality to compliance levels. Our commitment extends beyond analysis—we actively support you during inspection days and assist with post-inspection activities.
Independent Internal Inspection
Our team conducts an impartial internal audit at your facility, delivering a thorough review of observations, corrective actions, and corrections. This audit can be tailored to focus on your Quality Management System (QMS) as part of our ongoing support for your QA unit's independent yearly audit.
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Preparation & Support & Training for Regulatory Inspections
Navigate routine National Monitoring Authority inspections or FDA inspections seamlessly with our comprehensive services. We kickstart the process with an independent mock inspection, providing you with a detailed report of observations. Our support extends to preparing a robust Corrective and Preventive Action (CAPA) plan, offering consulting and training for employee behavior during regulatory inspections, providing support throughout the inspection, and handling the inspection report effectively.
Choose Global Pharma QA for a holistic approach to accreditation and compliance, ensuring your organization not only meets but exceeds regulatory standards with confidence.
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