FDA Inspection
ISO/IEC 17025 Audit Preparation
Comprehensive Inspection Readiness and Accreditation Support
FDA inspections are conducted to ensure laboratories comply with U.S. regulatory requirements (such as GMP, GLP, or GCP) and protect public health. Preparation focuses on making sure the lab is always inspection-ready, not scrambling at the last minute.
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FDA Inspection Preparation
This typically includes:
The goal is to reduce inspection risk, avoid observations (Form 483), and ensure smooth regulatory interactions.
- Reviewing quality systems, SOPs, and records for FDA compliance
- Ensuring data integrity (ALCOA+ principles)
- Verifying equipment qualification, calibration, and maintenance
- Assessing training records and competency of laboratory staff
- Conducting mock FDA inspections to identify gaps
- Preparing staff to confidently answer inspector questions
- Developing and reviewing CAPAs to address potential findings
ISO/IEC 17025 Audit Preparation
ISO/IEC 17025 applies to testing and calibration laboratories and focuses on technical competence and management system effectiveness. Audit preparation ensures the lab can demonstrate both.
The goal is to achieve or maintain accreditation, minimize nonconformities, and build a sustainable compliance system.
- Gap analysis against ISO/IEC 17025 requirements
- Review of quality manual, procedures, and technical records
- Verification of method validation/verification
- Evaluation of measurement uncertainty and traceability
- Review of proficiency testing and inter-laboratory comparisons
- Internal audits and management review readiness
- Preparing staff to explain technical activities during audits