Glossary
Explore our glossary of essential terms — a quick, engaging way to learn key concepts and see how they connect across SG Systems’ products.
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- 21 CFR Part 1
- 21 CFR Part 101
- 21 CFR Part 11
- 21 CFR Part 111
- 21 CFR Part 117
- 21 CFR Part 210
- 21 CFR Part 211
- 21 CFR Part 225
- 21 CFR Part 4
- 21 CFR Part 507
- 21 CFR Part 58
- 21 CFR Part 600-680
- 21 CFR Part 803
- 21 CFR Part 806
- 21 CFR Part 807
- 21 CFR Part 820
- 21 CFR Part 821
- 21 CFR Part 830
- 510(k) Submission
- 510(k) vs PMA
A
- Active Ingredient Potency Compensation
- Active-Equivalent Consumption
- Adjuvant & Surfactant Dosing Accuracy
- Advance Shipping Notice (ASN)
- Advanced Process Control (APC)
- Air Fluidization and Powder Aeration
- ALCOA / ALCOA+
- Alert & Action Limits – Statistical Process Control (SPC)
- Allergen Changeover Validation (Consumer Products)
- Allergen Changeover Verification
- Allergen Cross Contact
- Allergen Segregation Control
- Allergens – Priority Allergen Control
- Analytical Lot Link
- Annex 11
- Annual Product Review (APR)
- ANVISA RDC 301/2019 – Brazilian GMP
- Application Identifier (AI) – GS1 Data Elements
- Approval Workflow
- AQL (Acceptance Quality Limit)
- Artwork Versioning & Packaging Change Control
- Asset Calibration Status
- Audit Trail (GxP)
- Automated Batch Records
- Automated Batch Records – eBMR
- Automated Mixing and Collation
- Automated Spice & Functional Additive Batching
B
- Backflush Accounting
- Bake Profile Verification
- Baker’s Percent (Hydration Ratio)
- Bakery Bulk Bag and Sack Management
- Bakery Trolley Flow Control
- Barcode Validation
- Batch & Lot Traceability for CPG Manufacturing
- Batch Balancing
- Batch Genealogy
- Batch Manufacturing Record (BMR)
- Batch Material Verification
- Batch Reactor – Vessel Control
- Batch Recipe Execution (BRE)
- Batch Record Lifecycle Management
- Batch Release
- Batch Release Readiness
- Batch Review by Exception (BRBE)
- Batch Ticket
- Batch Validation
- Batch Variance Investigation
- Batch Weighing
- Batch Yield Reconciliation
- Batch-Specific Potency
- Batch-to-Bin Traceability
- Bill of Lading (BOL) – Legal Shipment Document
- Bill of Materials (BOM)
- Bin / Location Management
- Blend Uniformity Analysis (BUA)
- Blend Uniformity Testing (Riboflavin or Tracer Methods)
- BRCGS Clause 3.9 – Traceability Requirements
- BRCGS Meat Processing Controls (Issue 9)
- Bulk Density Testing
- Bulk Fragrance Concentrate Control
C
- Caking and Agglomeration Prevention
- CAPA – Corrective & Preventive Action
- Carton GTIN Verification
- Cartonization – Right-Size Packing
- Case Label Grade Marking
- Case, Carton & Pallet Label Synchronization (GS1 CPG)
- Catch Weighing
- Catch-Weight Sausage Batching
- Catch-Weight Tote Reconciliation
- Catch-Weight Traceability – Variable Weight Lots
- Cavity-Level Traceability
- CDSCO Schedule M – Indian GMP
- CE Marking
- Certificate of Analysis (CoA)
- CFIA SFCR – Canada Food Traceability
- Change Control
- Checkweigher Legal-for-Trade Verification
- Chemical Management System (CMS)
- Chub ID and Weight Tracking
- Clamshell Label Verification
- Clean-Down Validation Between Fragrances / Colors
- Cleaning Validation
- Cleaning-in-Place (CIP)
- CMO Management
- Co-Formulant Change Control
- Cold Chain Integrity Checks
- Cold Room Inventory Mapping
- Color Changeover Logging
- Component Identity & Barcode Verification
- Component Lot Traceability
- Component Release
- Computer System Validation (CSV)
- Computerized Maintenance Management System (CMMS)
- Concentration-Adjusted Charge
- Consumer Product Stability & Shelf-Life Studies
- Container Closure Integrity Checks
- Continued Process Verification (CPV)
- Control Limits (SPC)
- Cooked-Chub Weight Verification
- Cooling Tunnel Temp Logging
- Corrected Active Content
- Corrective Action Plan
- Corrective Action Procedure
- Corrective Action Request (CAR)
- Corrective Action vs Preventive Action
- Corrective and Preventive Action Form
- Corrective and Preventive Action Report
- Cosmetic Claims Substantiation
- Cosmetic Fill-Finish Line Verification
- Cosmetic Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Cosmetic Stability & Compatibility Studies
- Cost of Poor Quality (COPQ)
- Costco Supplier Food Safety Requirements
- Country of Issuance (COI)
- Country of Origin (COO)
- Critical Process Parameters (CPPs) – Batch Control
- Cross-Batch Lot Allocation
- Cross-Contact Prevention in Dry Blends
- Cross-Contamination Control
- Crust & Crumb Handling Inventory (Post-Bake)
- Crust Color Uniformity Testing
- Customer Complaint Handling Process
- Cycle Counting
D
- Data Integrity
- Data Retention & Archival
- Deaeration and Vacuum Mixing
- Design History File (DHF)
- Deviation / Nonconformance (NC)
- Deviation Management
- Device History Record (DHR)
- Device Master Record (DMR)
- Device UDI in Australia – AusUDID Transition
- Digital Twin (Manufacturing)
- Digital Work Instructions
- Directed Picking
- Directed Put-Away
- Dispensary Material Flow Optimisation
- Dock Loading – Outbound Staging & Handover
- Dock-to-Stock
- Document Control
- Document Control Plan
- Document Control SOP
- Document Control Standards
- Document Control System
- Document Management System (DMS)
- Dough Absorption Control
- Dough Ball Freezer Inventory Management
- Dough Bowl / Mixer Load Management
- Dough Rheology Assessment
- Dough Scaling
- Dough Temperature Critical Control
- Drug Supply Chain Security Act (DSCSA)
- Dual Verification
- Dust & Granule Integrity Control
- Dust Explosion Hazard (NFPA 652, ATEX)
- Dynamic Lot Allocation
- Dynamic Recipe Scaling
E
- EDQM CEP – Certificate of Suitability
- Electronic Batch Record (eBMR)
- Electronic Batch Record (EBR)
- Electronic Batch Record System
- Electronic Data Interchange (EDI)
- Electronic Device History Record (eDHR)
- Electronic MMR (eMMR)
- Electronic Operator Sign-Off
- Electronic Quality Management System (eQMS)
- Electronic Work Instruction (EWI) Management
- ELN – Electronic Laboratory Notebook
- EMA Centralised Marketing Authorisation Procedure
- EMA Variation Categories (Type IA / IB / II)
- Emulsion Stability Control
- End-Of-Arm Tooling Checks
- Enterprise Resource Planning (ERP)
- Environmental Monitoring (EM)
- EPA Registration Number Control
- EPCIS Traceability Standard
- Equipment and Line Assignment
- Equipment Qualification (IQ/OQ/PQ)
- Error-Proofing (Poka-Yoke)
- EU IVDR
- EU MDR 2017/745 – Medical Device Regulation
- EU QP Declaration of API GMP Compliance
- EU/UK Pharmacovigilance System Master File (PSMF)
- Exception-Based Process Review
- Expiration & Shelf-Life Control
F
- Factory Acceptance Testing (FAT)
- Failure Mode & Effects Analysis (FMEA)
- FDA 510(k) Clearance
- FDA 510(k) Database
- FDA ANDA – Abbreviated New Drug Application
- FDA Form 483 & Warning Letter Escalation
- FDA Pre-Approval Inspection (PAI)
- FEFO (First-Expire, First-Out)
- Field Lot Identification
- Field Trial Sample Control
- FIFO (First-In, First-Out)
- Fill-Weight & Volume Control (CPG Packaging)
- Fines and Coarse Particle Distribution
- Finished Goods Release
- Finished Goods Serialization & Batch Coding Accuracy
- Finished Product Sensory Evaluation
- First Article Inspection (FAI)
- Flavor & Fragrance Batch Consistency Control
- Flour Protein and Ash Variability Control
- Flour Scaling and Silo Weighing
- Food Defense (IA Rule)
- Food Safety Plan (FSP)
- Foreign Material Inspection
- Foreign Material Risk Assessment (FMRA)
- Fragrance Allergen Disclosure
- Fresh Produce QA Sampling
- Frozen Ingredient Slotting
- FSIS 9 CFR 417 HACCP System Requirements
- FSIS Appendix A – Lethality Compliance
- FSIS Appendix B – Stabilization (Cooling) Requirements
- FSIS Listeria Control Program (LCP)
G
- Gain-in-Weight vs. Loss-in-Weight Feeding
- GAMP 5
- GDP – Good Distribution Practice
- GFSI Global Food Safety Initiative
- GHS / Safety Data Sheet (SDS)
- Global Batch Traceability
- Global Trade Item Number (GTIN) – Item Identity
- GMP / cGMP
- Goods Receipt
- Gravimetric Weighing
- Grower Shipper Code Management
- GS1 / GTIN
- GS1-128 Case Label
- GS1-128 Intake Label Capture
- GS1-128 Internal Movement Scanning
- GS1-128 Lot Transfer Scanning
- GS1-128 Raw Material Intake Labeling
- GxP
- GxP Data Lake and Analytics Platform
H
- HACCP
- Hard Gating – Electronic Pass/Fail Controls
- Harvest Bin Traceability
- HAZOP
- Health Canada Drug Establishment Licence (DEL)
- Health Canada NOC & Drug Identification Number (DIN)
- Heijunka
- HFE (Human Factors Engineering)
- High-Risk Allergen
- HMI (Human–Machine Interface)
- Hold / Release Status for Finished Goods
- Hold & Release
- Hold Time Study (HTS)
- HPLC
- Hygienic Equipment Design for Powder Systems
- Hygroscopic Material Handling
I
- IBC & Drum Tracking
- ICH Q10
- ICH Q7
- ICH Q9 Quality Risk Management
- Identity Testing
- IEC 60601
- IEC 62304
- IFRA Compliance for Fragrances
- In-Process Assay Gate
- In-Process Control Checks (IPC)
- In-Process Controls (IPC)
- In-Process Quality Checks for Personal Care & Household Products
- In-Process Verification (IPV)
- Inclusion and Topping Weighing
- Incoming Inspection
- Incompatible Chemical Segregation
- Industrial Internet of Things (IIoT)
- Industry 4.0 – Smart Factory and Connected Operations
- Ingredient Conditioning Storage
- Installation Qualification (IQ)
- Instruction for Use (IFU)
- Intake-to-Grind Digital Handover
- Internal Audit
- International Nomenclature of Cosmetic Ingredients (INCI)
- Inventory Accuracy
- ISA-88 (S88) – Batch Control Standard
- ISA-88 Phases & Equipment Modules
- ISA-95 (S95) – Enterprise–Control Integration
- ISO 13485
- ISO 13485 Audit
- ISO 13485 Requirements
- ISO 13485 Standards
- ISO 14971 – Medical Device Risk Management
- ISO 22716 – Cosmetics GMP
- ISO 9001 – Quality Management Systems
- ISO Medical Device Standards
- ISO/IEC 17025 – Testing & Calibration Lab Competence
- ISO/IEC 22989 — AI Concepts and Terminology
- ISO/IEC 23053 — AI System Lifecycle Framework
- ISO/IEC 23893 — AI Risk Management Vocabulary
- ISO/IEC 23894 — AI Risk Management
- ISO/IEC 24027 — Bias in AI Systems
- ISO/IEC 24030 — AI Assessment Framework
- ISO/IEC 38507 — Governance of AI
- ISO/IEC 42001 — AI Management System
- ISO/IEC TR 24028 — AI Trustworthiness
- ISO/IEC TR 24029-1 — Robustness of Neural Networks
- ISO/IEC TR 24368 — Ethical and Societal Concerns of AI
J
- JHA (Job Hazard Analysis) / JSA – Task-Level Risk Control
- Jidoka (Autonomation)
- JIS (Just-in-Sequence)
- JIT (Just-in-Time) Manufacturing
- Job Queue – MES Scheduling & Dispatching
- Job Release
- Job Scheduling – Finite Capacity & Constraints
- Job Ticket (Production Order)
- Job Traveler – Digital Routing & Work Instructions
- Juran Trilogy
K
- Kaizen – Continuous Improvement
- Kanban – Pull Replenishment
- Kanban Board – Visual Work Control
- Karl Fischer Titration – Moisture Analysis
- KDE – Key Data Elements (FSMA 204)
- Kill Step Validation – Lethality Control
- Kilo Lab – Scale-Up Manufacturing
- Kitting – Pre-Assembly for Production
- Knowledge Management
- Kosher Compliance – Food Production
- KPI – Key Performance Indicator
L
- Label Copy & Regulatory Statement Control
- Label Verification – Barcode & UDI Checks
- Labeling Control – Artwork, Claims & Changes
- Labeling Medical Devices
- Layered Process Audits (LPA) – Tiered Checks
- Lead Time – Order-to-Ship Duration
- Lean Manufacturing – Waste Elimination
- LIMS – Laboratory Information Management System
- Line Balancing – Workload Leveling
- Line Clearance – Pre-Run Verification
- Load Cells & Weighing Systems
- LOD Adjustment
- Loss-in-Weight Feeder Calibration
- Lot Release – QA Disposition
- Lot Traceability – End-to-End Genealogy
- Lot/Batch Number (AI 10) – Source Traceability
M
- Machine Qualification Runs
- Machine Vision Inspection
- Macro Dosing – Bulk Component Weighing
- Management of Change (MOC)
- Manufacturing Data Historian (Process Historian)
- Manufacturing Execution System (MES)
- Manufacturing Operations Management (MOM)
- Manufacturing Traveler
- Mass Balance
- Master Batch Record (MBR)
- Master Manufacturing Record (MMR)
- Master Recipe Development
- Masterbatch Dosing Control
- Material Identity Confirmation
- Material Lot Assignment
- Material Requirements Planning (MRP)
- Material Review Board (MRB)
- Material Staging and Kitting
- Materials Consumption Recording
- MDSAP
- Measurement Systems Analysis (MSA)
- MEDDEV 2.7/1
- MEDDEV Vigilance
- Medical Device Classes
- Medical Device Clinical Trials
- Medical Device Design
- Medical Device Life Cycle
- Medical Device Quality Management System (QMS)
- Medical Device Regulations
- Medical Device Reporting (MDR)
- Medsafe GMP & WAND Notifications (New Zealand)
- MedWatch Form
- Metal Detector Verification Tests (3 mm / 4 mm Standards)
- MHRA GxP Data Integrity Expectations
- MHRA MIA & WDA(H) Authorisations
- Micro-Ingredient Dosing
- Microbial Control in Cosmetics Manufacturing
- Microbial Control Monitoring for Non-Food Consumer Goods
- Minor and Micro Ingredient Stations (Bakery)
- Mixed Load Segregation
- Mixer-to-Smokehouse Load Validation
- Mixer-to-Stuffer Lot Reconciliation
- Mock Recall Performance
- Model Predictive Control (MPC)
- Modernization of Cosmetics Regulation Act (MoCRA)
- Moisture Loss and Bake Yield Testing
- Mold Maintenance Scheduling
- Mold Setup Verification
- Molding Defect SPC
- Molding Parameter Windows
- Mutual Recognition & Reliance in GMP Inspections
N
- National Drug Code (NDC)
- National Institute of Standards and Technology (NIST)
- New Product Introduction (NPI)
- New Zealand Data Sheet & CMI
- Nitrosamine Risk Assessment – Impurity Control
- Nonconformance
- Nonconformance Management
- Nonconformance Report (NCR)
- Nonconforming Material Report (NCMR)
- Notification of Change (NOC)
- Notified Body
O
- Obsolescence Management
- Off-Spec Batch Rework
- On-Time In-Full (OTIF)
- One-Piece Flow
- One-Up / One-Down Traceability (USDA + Global)
- Operational Qualification (OQ)
- Order Picking – Warehouse Fulfillment
- Out-of-Service Tagging
- Out-of-Specification (OOS)
- Out-of-Trend (OOT)
- Overall Equipment Effectiveness (OEE)
P
- Pack & Ship – Compliant Order Fulfillment
- Pack Line Grade Sizing
- Packaging Bill of Materials (CPG-Specific BOM)
- Packaging Line Catch-Weight Integration
- Packaging Line Clearance Verification
- Packaging Material Consumption Recording
- Pallet Building – Unit Load Creation
- Pallet PTI Label Control
- Pan, Tin and Sheet Asset Tracking
- Paperless Dispensing
- Paperless Manufacturing
- Paperless Molding Tickets
- Par Level Management for Bakery Ingredients
- Part Labeling Compliance
- Particle Size Reduction & Milling Control
- Percent Solids Basis
- Personal Protective Equipment (PPE)
- pH & Water Hardness Adjustment
- Pharma 4.0 – Digital Transformation of GxP Manufacturing
- Pharmaceutical Quality Management System (Pharma QMS)
- PIC/S Guide to GMP (PE 009)
- PMDA GMP Inspection System (Japan)
- Policies – QMS Governance & Control
- Post-Smokepath GS1-128 Re-Labeling
- Postmarket Surveillance
- Potency Adjustment Factor
- Potency Basis
- Potency-Normalised Yield
- Potency/Assay Adjustment – Recipe Compensation
- Powder Cohesiveness Classification
- Powder Conditioning (Temperature & Humidity Control)
- Powder Electrostatic Charge Management
- Powder Flowability Index
- Pre-Cooler Load Tracking
- Pre-Mix Cart Tracking and Staging
- Pre-Weigh & Minor Ingredient Verification
- Predicate Device
- Predicate Rule
- Predictive Maintenance (PdM)
- Preferment Scaling (Poolish / Biga / Levain)
- Preservative Efficacy (Challenge Testing)
- Process Analytical Technology (PAT)
- Process Capability (Cp/Cpk)
- Process Control Plan (PCP)
- Process FMEA (PFMEA)
- Process Performance Qualification (PPQ)
- Process Safety Management (PSM) – OSHA 1910.119
- Process Validation
- Produce Traceability Initiative (PTI)
- Product Quality Review (PQR)
- Production Scheduling
- Products & Formulas
- Proofing Room Inventory Tracking
- Proofing Validation (Dough Development)
- PTI Case Pallet Linking
- Purchase Orders – Procurement & Receiving Control
Q
- QA Systems
- QMS Manual
- Qualified Person (QP) Release
- Quality Agreement – Sponsor/CMO Expectations
- Quality Assurance (QA)
- Quality Assurance Auditing
- Quality Assurance Process
- Quality Assurance Testing
- Quality Assurance vs Quality Control
- Quality by Design (QbD)
- Quality Control (QC) – Testing & Release Evidence
- Quality Control in Manufacturing
- Quality Control System (QCS)
- Quality Management
- Quality Management Process
- Quality Management System (QMS)
- Quality Management System Regulation (QMSR)
- Quality Risk Management (QRM)
- Quarantine – Quality Hold Status
R
- Raw vs RTE Zoning Requirements
- Real-Time Release Testing (RTRT)
- Recall Readiness – Rapid Traceability & Response
- Recipe and Parameter Enforcement
- Recipe Formulation – Product & Process Design
- Recipe Management – Master Recipes & Control
- Recipe Management Software
- Recipe Management System
- Recipe Scaling & Basis
- Recipe Versioning – Change Control for Formulas
- Record Retention – Data Integrity & Archival
- Regrind Usage Control
- Release Status (Hold/Release) – QA Disposition
- Repack and Rework Traceability
- Replenishment Pathing
- Resin Changeover Control
- Resin Dryer Verification
- Resin Lot Traceability
- Resin Moisture Recording
- Resin Segregation in WMS
- Restricted Use Pesticide Traceability
- Retailer Spec Compliance
- Returns (RMA) – Reverse Logistics & Quality
- Rework – Controlled Reprocessing
- Rework & Repack Traceability
- Rework Traceability – Controlled Re-Use
- Risk Management (QRM) – Risk Register & Controls
- Risk Matrix
- Root Cause Analysis (RCA)
- Routing – Operation Sequence & Resources
- Routing and Operation Sequencing
S
- Sampling – Statistical & GMP Sampling Plans
- Scrap and Reject Coding
- Scrap Dough Rework (Bakery Reuse)
- Segregation Control in Dry Blends
- Sequenced Ingredient Weighing (Salt–Protein–Ice Order)
- Serial Shipping Container Code (SSCC)
- Serialization – Unit/Case/Pallet Identification
- Shelf-Life & Expiry Dating
- Shipping Manifest
- Sifter and Mesh Validation
- Silo and Gaylord Tracking
- Silo Rat-Holing and Bridging
- Smokehouse Airflow and Rack Position Mapping
- Smokehouse Load Verification Scanning
- Solvent Content Correction
- Spice and Functional Ingredient Pre-Weigh Verification
- Sponge and Dough System
- SQF Edition 9 – Traceability & Mass Balance
- Stability Studies – Product Shelf-Life Evidence
- Stability-Driven Overage
- Standard Deviation (SD)
- Standard Operating Procedure (SOP)
- Statistical Process Control (SPC)
- Sterilization-in-Place (SIP)
- Supervisory Control & Data Acquisition (SCADA)
- Supplement Facts Label
- Supplier Corrective Action Request (SCAR)
- Supplier Qualification – Approval & Monitoring
- Supplier Quality Management (SQM)
- Supplier Risk Management
- Supplier Verification of COAs
- Supply Chain Risk Management
- Suspension Concentrate Viscosity Control
T
- Tank Farm Inventory Control
- Tare Verification and Container Control
- Tare Weight
- Target Dough Temperature Control
- Temperature Mapping
- Temperature-Controlled Storage
- Test Method Validation (TMV)
- Test-Driven Setpoint Adjustment
- Tests – Laboratory Analyses & Review
- Texture Profile Analysis (Bakery Crumb Quality)
- TGA GMP Clearance for Overseas Manufacturers
- TGA Release for Supply (RFS)
- Therapeutic Goods Administration (TGA)
- Therapeutic Goods Orders (TGO)
- Tolerable Negative Error (TNE)
- Tooling Lifecycle Management
- Total Productive Maintenance (TPM)
- Traceability – End-to-End Lot Genealogy
- Trailer Seal Verification
- Training Matrix – Role-Based Competency
U
- Unique Device Identification (UDI)
- Unit of Measure (UoM) – Conversion & Consistency
- United States Pharmacopeia (USP)
- Upper Control Limit (UCL) – SPC Threshold
- Upstream Traceability – Supplier-to-Batch Linkage
- User Acceptance Testing (UAT)
- User Access Management (UAM) – Roles & Permissions
- User Requirements Specification (URS)
- Utilities Qualification (UQ)
- UV-Visible Spectrophotometry (UV-Vis)
V
W
- Walmart SQEP Requirements (Meat Category)
- Warehouse Locations – Bin & Zone Topology
- Warehouse Management System (WMS)
- Wave Picking
- Wearable Medical Devices
- Weigh-and-Dispense Automation
- Weighing & Dispensing
- WHO Prequalification for Medicines & Vaccines
- Work Order Execution
- Work-in-Process (WIP) – In-Flight Inventory