FDA Inspection Audit Support
Inspection Readiness. Audit and preparedness. Product, systems, and facility qualification and validation.
GxP Audit Support
Our team of FDA experts understands the importance of a successful inspection, and the role that a detailed audit can play in your inspection outcome.
We know the importance of fostering a culture of quality and establishing a proactive quality management system.
Whether you are in need of a comprehensive corporate quality management system audit or a completely focused site audit, our thorough, highly-effective, attentive and scalable FDA audit support services help you reduce FDA inspection risks while you continue to focus on your business objectives.
Validation / Qualification Activities:
- Evaluation of products, equipment, and facilities
- Qualification of policies, procedures, protocols, and master plans
- Computer Systems Validation and 21CFR Part 11 Compliance
- Validation of:
- Manufacturing, labelling, and packaging processes
- Cleaning and sterilization systems and processes
Other Inspection Related Activities:
- Internal audits or GAP assessments of the Quality Management System
- Vendor and Supplier audits
- GDP audits
- Due Diligence
Audits Include the Following Customizable Components
- A pre-audit kickoff call outlining client objectives and daily agenda for the audit, including customized audit approach:
- Formal FDA Audit, “Hats-on, Hats-off” Audit, deep dive into specific area, high level “checkup”, etc.
- Onsite or remote audit with guidance before and during the inspection
- An initial summary of the overall audit findings at the close of the onsite visit
- A detailed, written audit report outlining Observations & Deficiencies (categorizing by criticality)
- A risk-based Corrective Action Plan (Premier FDA Solutions can also assist with any needed post-audit remediation of documents and Quality System GAPs.)
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