Audit Preparedness

Consulting: Audit Preparedness
FMD K&L offers a comprehensive range of consulting services to help prepare for FDA and other regulatory agency inspections and International Standards Organization (ISO) audits:
  • Review of standard operating procedures (SOPs): Ensure your SOPs are current, accurately describe your internal processes & contain neither too much nor too little detail
  • Review of training requirements: Ensure your staff is sufficiently trained to understand & comply with regulatory standards
  • Review of data repository: Ensure data are reliable & secure, an area of particular importance for an electronic data repository developed in house
  • Mock audit planning: Test client readiness for an actual audit
  • Review of evidence availability: Ensure that all documents regulators are likely to ask for can be produced quickly, including SOPs, bills of materials (BOMs), engineering change orders (ECOs) for medical devices, reports, reviews, authorizations & notes