FDA inspection-readiness glossary

Plain-language definitions for terms used in inspection-preparation conversations. These are orientation aids; confirm applicable requirements and decisions with qualified regulatory, quality, and legal professionals.

• Inspection readiness

  The ongoing ability to identify, retrieve, and explain relevant records and workflows when an inspection request arrives. Readiness work does not guarantee an inspection outcome.

• Evidence inventory

  An index of records and other evidence used to support a workflow, with enough context to find the source, identify its owner, and understand its version or limits.

• Standard operating procedure (SOP)

  An approved description of how a recurring activity is expected to be performed. Reviewing the procedure alongside actual practice can reveal questions that need follow-up.

• Deviation

  A documented departure from an approved procedure or defined expectation. The organization’s quality process determines how a specific event is assessed and handled.

• Corrective and preventive action (CAPA)

  A quality process for investigating a problem, addressing its cause, and evaluating actions intended to reduce recurrence. A readiness finding does not automatically require a CAPA.

• Audit trail

  A record of system activity that helps reconstruct what changed, when it changed, and who performed or reviewed the activity. Applicable controls depend on the system and use.

• Mock inspection

  A planned rehearsal of inspection activities, such as retrieving requested records or practicing interview handoffs, used to find process gaps before a real inspection.