Quality System and Inspection Readiness

Quality systems should provide clear responsibilities, dependable documentation, and appropriate oversight of development activities.

I help emerging and clinical-stage organizations establish phase-appropriate processes and address gaps across GMP, GCP, and GCLP activities, working with the relevant quality and technical specialists.

• Quality system and documentation gap assessments.
• SOP development, review, and harmonization.
• Document control and training processes.
• Vendor and CRO oversight frameworks.
• Deviation and CAPA process support.
• Data integrity and traceability practices.
• Audit preparation and inspection readiness.
• Remediation planning and action tracking.

A prioritized quality gap assessment, remediation roadmap, agreed procedures, and readiness tracker with clear owners and responsibilities.