5 questions. Identifies whether your batch release decisions can be defended under direct FDA investigator questioning.
Is batch release authorization documented as a named decision event?
Is a decision owner recorded at the time of release?
Are the criteria used to make the release decision formally recorded?
Can you reconstruct the exact evidence reviewed before the release decision?
Is there a timestamped authorization record that answers: "Who authorized this and when?"
Get your full risk breakdown, identified gaps, and a defensible authorization record you can use during inspection.
Please complete all fields with a valid work email.
No spam. Your results are sent immediately.