Audit Preparedness

FMD K&L offers a comprehensive range of consulting services to help prepare for FDA and other Regulatory Agency Inspections and ISO audits:

  • Review of standard operating procedures (SOPs)— To ensure that your SOPs are current, accurately describe your internal processes, and contain neither too much nor too little detail
  • Review of training requirements—To ensure that your staff is sufficiently trained to understand and comply with regulatory standards
  • Review of data repository—To ensure that data is reliable and secure, an area of particular importance for an electronic data repository that has been developed in house
  • Mock audit planning—To test clients’ readiness for an actual audit
  • Review of evidence availability—To ensure that all documents that regulators are likely to ask for can be produced quickly. Relevant documents include SOPs, bill of materials(BOMs), engineering change orders(ECOs) for medical devices, reports, reviews, authorizations, and notes