Pharma & Biotech

A clinical drug product lot fails release, and the trace leads back to the drug substance lot it used. See how the team confirms which lots it affected.

A Grade B filling room, from site map to lab request. See how a quality team maps sampling points, builds a weekly plan and gets a lab request for every point.

A viscosity result on a batch release record gets corrected, and the notebook entry gets signed. The Audit Log keeps both values.

See how a scientist creates a notebook entry from a template, records results and signs with a PIN, and how QA approves the release record.

See how an environmental monitoring team sets up its monitoring locations, places sampling points on the real floor plan and prints it for the people taking samples.

Plan every sampling round. See how an EM team builds a sampling plan from the site map, sets the schedule and gets a lab request for every point.

Eight formulation candidates for the mAb-204 drug product compete to move forward. See how the team compares recipes, checks targets and plots stability curves.

FDA warning letters describe EM records that didn't match what happened in the lab. See how a QC microbiology lab keeps every plate traceable through to QA sign-off.