A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.

A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.

InfraScan Inc. has developed a handheld device for detecting bleeding in the brain in head trauma patients. Such trauma typically causes blood from ruptured vessels to pool in the skull cavity. The trapped blood compresses the brain and increases intracranial pressure, which leads to brain damage. However by beaming near-infrared light at the brain and then analyzing the light reflected back at the device, the Infrascanner reveals the presence or non-presence of an intracranial hematoma, for triage or follow-up diagnostics.