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?