The Professional Pack

Professional Pack Contents

  • Everything in Starter

  • Nonconformance & CAPA System (SOP + 8D + 5-Why + CAPA/MRB register)

  • Complaint Handling System (SOP + complaint form + triage rules + linkage to CAPA/PMS)

  • Internal Audit Toolkit (SOP + audit plan + checklist + audit report)

  • PMS & Vigilance Toolkit (PMS Plan, PMS Report, FSCA SOP, FSN template, trend analysis sheets)

  • QMS Validation Pack (URS, Validation Plan, IQ/OQ/PQ protocols and reports, summary templates)

  • Traceability & UDI Toolkit (UDI labels, Device Log, Distribution Register, DHR index, DHF mapping)

  • Design & Development System (Design Plan, Inputs, Outputs, Reviews, V&V, DHF index, trace matrix)