Audit Readiness & Inspection Support (FDA / TÜV / Notified Bodies / Customers)

Goal: Make audits predictable and evidence-based.

What Pharmlancer delivers:

  • Audit readiness assessment (processes, records, training, CAPA status, supplier controls)


  • Evidence mapping: where requirements are met and which records prove it


  • “Audit pack” preparation: key SOPs, KPIs, CAPA summaries, management review inputs, qualification/validation packages


  • Mock audits and interview coaching for SMEs and management


  • Audit-day support (remote/on-site)


  • Post-audit remediation: observations → CAPA plan → implementation → effectiveness checks

Audit types supported:

  • FDA inspection readiness (Medical Devices / QMS): inspection-style preparation, retrieval drills, CAPA and supplier control readiness


  • Notified Body audit readiness (EU MDR) including readiness for sampling and on-site QMS assessment (e.g., TÜV)


  • Customer audits (pharma/food/medtech) and supplier-related audit support


  • Authority inspections where applicable (e.g., IGJ readiness)

Contact

Share an audit date, inspection scope, deviation/CAPA situation, supplier issue, or qualification/validation project. Pharmlancer will respond with a suggested approach and next steps.

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