A key attribute of any effective quality system is its ability to evaluate, implement, and track corrective actions to process variations. These corrective actions arise from many inputs:

  • Manufacturing operations
  • Investigations
  • Regulatory audits
  • Product surveillance, i.e, complaints and adverse events

DBT has extensive experience in the development and implementation of effective corrective action procedures that represent the culmination of a number of supporting structures and input:

  • Conducting proper investigations
  • Identifying sources of CAPA
  • Determining the corrective or preventive actions
  • Validating the actions prior to implementing them
  • Determining the effectiveness of the actions

CAPA represents a key area that FDA concentrates upon because it goes right to the heart of product problems. Is your company prepared?