Laboratory FDA Inspection Readiness
Laboratory inspection support. Independent support scoped to your product, facility, and operating needs.
Define the laboratory scope
We start with the laboratory’s work: GMP quality control, contract testing, nonclinical studies, diagnostics, or another regulated activity. GLP, GMP, and diagnostic laboratory requirements differ; ISO/IEC 17025 accreditation alone does not establish FDA compliance.
Review records and laboratory controls
Scope may include methods and validation, sample and reagent traceability, raw data, chromatography review, out-of-specification investigations, stability, equipment records, computerized systems, and training.
Practice inspection execution
Prepare analysts and quality staff for interviews, record retrieval, facility walkthroughs, and daily debriefs. Findings are prioritized in a scoped report with practical follow-up actions.
Discuss the scope
Inspection readiness · Free planning templates · Supplier qualification · Laboratory inspections