Identifier Modules
Identifier is modular. Each module covers one part of the visual inspection lifecycle and maps to the sections of USP <1790> it supports.
Defect Library
A master record of every defect, with descriptions, criticality, and images, organized by product family. Supports inspector training and process knowledge.
USP <1790> 1.3 Use of libraries · 4.1 Particle definitions · 7.7 Training and qualification of human inspectors
Test Standards
An inventory of physical defect standards and blank units, assigned to the test sets used for training and detection studies.
USP <1790> 7.1 Standards · 7.2 Preparing defect standards · 7.3 Particle types · 7.5 Test sets · 7.6 Types of test sets
Calibration
Establishes the probability of detection for each unit in a test set.
USP <1790> 7.4 Rejection probability determination
Training and Qualification
Blinded qualification of manual inspectors and vision systems against calibrated test sets, documented electronically.
USP <1790> 6.1 to 6.3 Manual, semi-automated, and automated inspection · 7.7 to 7.9 Inspector qualification and requalification
Scheduling
Requalification schedules for inspectors and machines, so qualifications stay current.
USP <1790> 7.9 Requalification
Configuration
Product families, users, roles, and lists, managed by site administrators to fit each site.
Inspection
Records 100% inspection results for each batch, with trending against limits.
USP <1790> 3.1 100% inspection of each unit · 4.4 Trending and limits evaluation
Reject Characterization
Classifies and trends rejected units to show where defects come from and where to focus remediation.
USP <1790> 5.1 Defect classification
Upstream Materials
Defect control for components, raw materials, and single-use supplies before they reach manufacturing.
USP <1790> 4.1 to 4.3 Prevention and control of specific components and processes
AQL Inspection
Records the statistically based AQL inspection performed after 100% inspection.
USP <1790> 3.2 Acceptable quality limits inspection · 4.4 Trending and limits evaluation
Forensic Particle ID
Documents particle identification to support root cause investigation and CAPA.
USP <1790> 3.1 and 3.2 Rejects from 100% and AQL inspection · 5.1 Defect classification
Particle Testing
Records destructive sub-visible and visible particle testing results.
USP <1790> 5.2 Destructive testing · 5.3 Supplemental testing