QualityGuard

Deviations

Manage and investigate quality deviations across your sites.

DEV-2023-001Major Site A - Boston

Temperature Excursion in Bioreactor 4

Temperature spiked to 38.5°C for 15 minutes during fermentation cycle. Standard operating range is 36.0-37.5°C.

Status

Investigating
DEV-2023-002Minor Site B - Austin

pH Drift in Buffer Preparation

pH reading dropped to 6.8 during buffer prep. Target is 7.2 ± 0.1.

Status

Open
DEV-2023-003Critical Site A - Boston

Particulate Matter in Vial Inspection

Visual inspection detected unidentified dark particles in 3 vials from Batch B-402.

Status

Investigating
DEV-2023-004Critical Site C - Berlin

Pressure Drop in Filtration Unit

Unexpected pressure drop across filter membrane indicating potential integrity breach.

Status

Closed
DEV-2023-005Major Site B - Austin

Labeling Error on Packaging Line 2

Incorrect expiration date printed on 50 units. Detected during QC check.

Status

Closed