Assessment and Advisory Services

FMD K&L’s assessment and advisory services include planning, execution, documentation & closure assistance for the assessment findings

Below are some of our capabilities in this field:

  • Quality & information systems: We offer compliance checks, CAPA & Kaizen implementation In order to help manage operational information & ensure audit preparedness & quality adherence
  • Vendor evaluation: Periodic vendor assessment, performance benchmarking, and evaluation are conducted to ensure that vendors & partners meet organization policies & industry compliance
  • Computer systems validation: We ensure all systems are 21 CFR Part 11-compliant through pre-qualification assessments, SOP review, controls checks for audit trails, data accuracy, reliability & consistency
  • GxP assessment: Evaluating GMP, GLP & GVP verifies compliance with GxP legislation