Glossary of Terms

21 CFR — Title 21, Code of Federal Regulations
FDA regulations covering food, drugs, medical devices, and related regulated products.

21 CFR Part 11 — Electronic Records; Electronic Signatures
FDA requirements governing electronic records and electronic signatures. Particularly important when equipment stores, modifies, approves, or transfers regulated production data.

CGMP / cGMP — Current Good Manufacturing Practice
FDA requirements intended to ensure products are consistently manufactured and controlled according to established quality standards.

GMP — Good Manufacturing Practice
General framework governing controlled manufacturing of regulated products.

GxP — Good “x” Practice
Umbrella term for regulated quality practices, including GMP, GLP, GCP, GDP, etc.

IQ — Installation Qualification
Documented verification that equipment has been installed correctly according to approved specifications.

OQ — Operational Qualification
Documented verification that equipment operates correctly throughout its defined operating ranges.

PQ — Performance Qualification
Verification that the equipment consistently performs as intended under actual production conditions.

FAT — Factory Acceptance Test
Testing performed at the equipment manufacturer's facility prior to shipment.

SAT — Site Acceptance Test
Testing performed after equipment has been installed at the customer's facility.

URS — User Requirements Specification
Document defining what the customer requires the equipment or system to accomplish. Typically forms the foundation for equipment design and validation.

FS / FRS — Functional Specification / Functional Requirements Specification
Defines how a system will function to satisfy the URS.

DS — Design Specification
Detailed description of how the equipment or system is designed to satisfy its requirements.

DQ — Design Qualification
Documented verification that the proposed design is appropriate for its intended use.

CSV — Computer System Validation
Documented evidence that a computerized system consistently performs according to its intended use and regulatory requirements.

CSA — Computer Software Assurance
FDA's modern, risk-based approach to establishing confidence in software used in production and quality systems.

CAPA — Corrective and Preventive Action
Formal process for identifying, correcting, and preventing quality problems.

SOP — Standard Operating Procedure
Controlled instructions describing how a specific activity or process is performed.

NCR — Non-Conformance Report
Documentation of a product, process, or condition that fails to meet an established requirement.

QMS — Quality Management System
The policies, processes, procedures, and records used to manage quality within an organization.

Change Control
Formal process used to evaluate, approve, document, and implement changes to validated equipment, software, processes, or documentation.

Audit Trail
Secure record showing who performed an action, what changed, and when it occurred. Important in Part 11 environments.

AIDC — Automatic Identification and Data Capture
Technologies used to automatically identify products and capture data, including barcodes and RFID.

1D Barcode
Linear barcode such as Code 128 or GS1-128.

2D Code
Two-dimensional symbol capable of carrying substantially more data in less space than a traditional linear barcode.

DataMatrix
2D barcode commonly used in pharmaceutical and medical-device applications.

GS1-128
GS1-compliant implementation of Code 128, commonly used on cases and logistics packaging.

X-Dimension
Width of an individual barcode module. Critical to determining the physical size and readability of a barcode.

Module
Individual square element within a 2D code.

Quiet Zone
Required clear area surrounding a barcode.

BWR — Bar Width Reduction
Compensation applied during barcode creation or printing to account for print growth.

Verification
Objective measurement of barcode quality against an established standard.

Validation
Evidence that a process or system consistently produces the intended result.

Scanner / Reader
Device that decodes a barcode. Successfully scanning a barcode does not necessarily mean that the barcode meets verification standards.

OCV — Optical Character Verification
Confirms that printed characters match expected characters.

OCR — Optical Character Recognition
Technology that reads printed characters and converts them into machine-readable information.

OCR-B
Standardized font commonly used for machine-readable and human-readable pharmaceutical coding applications.

Vision Inspection
Camera-based inspection used to verify presence, position, content, quality, or correctness of printed information and packaging components.

ISO/IEC 15415
Barcode print-quality standard for 2D symbols.

ISO/IEC 15416
Barcode print-quality standard for linear/1D barcodes.

ISO/IEC 16022
Standard defining DataMatrix symbology.

Grade
Barcode-quality score resulting from verification. Commonly expressed as 4.0–0.0 or A–F depending on the reporting convention.

Print Contrast
Difference between light and dark areas of a printed code.

Fixed Pattern Damage
2D barcode quality measurement relating to damage or defects in required finder/timing patterns.

Modulation
Measurement of consistency in contrast across barcode elements.

Axial Nonuniformity
Measurement of distortion along the horizontal or vertical axes of a 2D code.

Unused Error Correction
Measurement of how much error-correction capability remains after accounting for defects in a DataMatrix.