Documentation of your CAPA process can be accomplished manually, electronically, or as a hybrid of both methods.
When managing a paper-based system, you will need a form for reporting and identifying non-conformities. Training should take place on the reporting form so that any member of the laboratory team can communicate observations to the correct personnel. There are a few examples of manual reporting forms found in the Clinical and Laboratory Standards Institute (CLSI) document, QMS11, Management of Nonconforming Events; Approved Guideline, 2nd ed.
Electronic databases for NCE management should ideally make reporting easy and accessible, allow for quick categorization and trending, provide unique tracking numbers, and allow for robust queries to provide management reports.
