Authenticity of R&D, clinical and production records, compliance of personnel, equipment, materials, processes and environment, and consistency between on-site status and registration application documents.
Identify Missing Contents and Non-standard Items in Advance
Conduct mock document reviews on design and development documents, validation reports as well as Device Master Record (DMR).
Complete Closed-loop Management Prior to Official Inspection
Issue audit gap analysis report and rectification recommendation checklist, and complete closed-loop before official inspection.
