The purpose of the gap assessment (or Inspection Readiness gap assessment) is essentially to determine how ready an organization is for an inspection. For DArcy Compliance Consulting, the gap assessment is a critical first step in the road to establishing a state of Inspection Readiness. Our framework for conducting a gap assessment is a four step process, comprising:

  1. Conducting interviews – with key stakeholders across the organization
  2. Review clinical documentation (protocols, SOPs, training records etc.)
  3. Synthesize into themes  and trends, strengths, gaps
  4. Present gaps and recommendations to address gaps

The output from the gap assessment is a report outlining gaps to be addressed and priority for gap closure activities. DArcy Compliance Consulting typically continues to partner with our clients in helping to ‘close’ gaps through a range of gap closure projects which might include for example development of SOPs, establishing and rolling out training, conduct of vendor audits, assessment of TMF etc. See a case study in Clinical Compliance Gap Assessment.