Documentation

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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about The Basics of Non-Conforming Event Management for Clinical Laboratory Services (online CE course)
Documentation

Throughout the entire CAPA process, be sure to document each of these workups while you perform them: the initial reporting, the investigation and analysis, the action implementation, the validation of effectiveness, the training and communication, and the management review.
Documenting the complete process is essential to meeting regulatory requirements.
A well-designed NCE management program will enable documentation to occur every step of the way.
Inspectors will want to see evidence that non-conformities are handled appropriately, effectively, and in a timely manner. Your laboratory's documents will enable them to see this readily.