Mock Pre-Approval Inspection Audits

Prepare and conduct Mock Pre-Approval Inspection Audits
Prepare staff for inspection protocols
Report potential inspectional findings and provide guidance to remediate deficiencies

GCP Audit

GCC will:

Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs.

Review computer systems procedures and documentation, including those for security, back-up, and recovery

Review QA unit reporting structure, auditing practices, and CAPA procedures