Inspection Readiness
Inspection Readiness is achieved by implementing a QMS and auditing the QMS to ensure it is functioning properly. We design QMS with SOPs that define processes for hosting inspections, responding to inspections, entering inspection findings into CAPA and resolving. Our overall QMS will make your organization inspection ready.
Aiming for permanent GCP, GMP or GLP inspection readiness is essential, whether preparing for an EU or FDA inspection, or a 3rd party or other partner audit.
Good Clinical Consultants has the expertise to provide services supporting the organization in introducing a program for GCP/GMP/GLP Inspection readiness and preparing for FDA and EU inspections.
Inspection Readiness
GCC will:
Perform an assessment of inspection readiness at the site
Conduct Mock Pre-Approval Inspection audits
Identify and remediate deficiencies, ie "red flags" to FDA inspectors
Prepare personnel for inspector interviews