Throughout the entire CAPA process, process documentation is required to include: initial reporting, investigation and analysis, action implementation, validation of effectiveness, training, communication, and management review.
Documenting the complete process is essential to meeting regulatory requirements.
A well-designed NCE management program will be structured to require and enable documentation at every step of the process.
Inspectors will review the documentation to verify that non-conformities are handled appropriately, effectively, and in a timely manner.
