Issue / CAPA Log (OBX319-301)
Document ID: QA-003
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)
Issue / CAPA Log — OBX319-301
Corrective- and preventive-action register for OBX319-301: issue description, root-cause analysis, corrective and preventive actions, owners, due dates, and effectiveness checks. ICH E6(R3) quality management.