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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A
- Advance Shipping Notice (ASN)
- ALCOA / ALCOA+
- Alert & Action Limits – Statistical Process Control (SPC)
- Allergen Segregation Control
- Allergens – Priority Allergen Control
- Annex 11
- Annual Product Review (APR)
- Application Identifier (AI) – GS1 Data Elements
- Approval Workflow
- AQL (Acceptance Quality Limit)
- Asset Calibration Status
- Audit Trail (GxP)
- Automated Batch Records
- Automated Batch Records – eBMR
B
- Backflush Accounting
- Baker’s Percent (Hydration Ratio)
- Barcode Validation
- Batch Genealogy
- Batch Manufacturing Record (BMR)
- Batch Reactor – Vessel Control
- Batch Release
- Batch Ticket
- Batch Validation
- Batch Weighing
- Batch-to-Bin Traceability
- Bill of Lading (BOL) – Legal Shipment Document
- Bill of Materials (BOM)
- Bin / Location Management
- Blend Uniformity Analysis (BUA)
- BRCGS Clause 3.9 – Traceability Requirements
C
- CAPA – Corrective & Preventive Action
- Cartonization – Right-Size Packing
- Catch Weighing
- Catch-Weight Traceability – Variable Weight Lots
- Certificate of Analysis (CoA)
- CFIA SFCR – Canada Food Traceability
- Change Control
- Chemical Management System (CMS)
- Cleaning Validation
- Component Release
- Computer System Validation (CSV)
- Continued Process Verification (CPV)
- Control Limits (SPC)
- Cost of Poor Quality (COPQ)
- Country of Issuance (COI)
- Country of Origin (COO)
- Cross-Contamination Control
- Cycle Counting
D
- Data Integrity
- Data Retention & Archival
- Design History File (DHF)
- Deviation / Nonconformance (NC)
- Device History Record (DHR)
- Device UDI in Australia – AusUDID Transition
- Directed Picking
- Directed Put-Away
- Dock Loading – Outbound Staging & Handover
- Dock-to-Stock
- Document Control
- Document Management System (DMS)
- Drug Supply Chain Security Act (DSCSA)
- Dual Verification
- Dynamic Lot Allocation
E
- Electronic Batch Record (eBMR)
- Electronic Data Interchange (EDI)
- Electronic MMR (eMMR)
- ELN – Electronic Laboratory Notebook
- Environmental Monitoring (EM)
- EPCIS Traceability Standard
- Equipment Qualification (IQ/OQ/PQ)
- Error-Proofing (Poka-Yoke)
- EU MDR 2017/745 – Medical Device Regulation
- Expiration & Shelf-Life Control
F
G
H
I
- ICH Q10
- ICH Q7
- Identity Testing
- In-Process Controls (IPC)
- Incoming Inspection
- Installation Qualification (IQ)
- Instruction for Use (IFU)
- 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 14971 – Medical Device Risk Management
- ISO 22716 – Cosmetics GMP
- ISO 9001 – Quality Management Systems
- ISO/IEC 17025 – Testing & Calibration Lab Competence
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 Verification – Barcode & UDI Checks
- Labeling Control – Artwork, Claims & Changes
- 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
- Lot Release – QA Disposition
- Lot Traceability – End-to-End Genealogy
- Lot/Batch Number (AI 10) – Source Traceability
M
- Machine Vision Inspection
- Macro Dosing – Bulk Component Weighing
- Management of Change (MOC)
- Manufacturing Operations Management (MOM)
- Mass Balance
- Master Batch Record (MBR)
- Master Manufacturing Record (MMR)
- Material Requirements Planning (MRP)
- Material Review Board (MRB)
- Measurement Systems Analysis (MSA)
- MES Manufacturing Execution System
- Micro-Ingredient Dosing
- Mock Recall Performance
- Modernization of Cosmetics Regulation Act (MoCRA)
N
O
P
- Pack & Ship – Compliant Order Fulfillment
- Pallet Building – Unit Load Creation
- Paperless Manufacturing
- Personal Protective Equipment (PPE)
- PIC/S Guide to GMP (PE 009)
- Policies – QMS Governance & Control
- Potency/Assay Adjustment – Recipe Compensation
- Predicate Rule
- 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
- Purchase Orders – Procurement & Receiving Control
Q
R
- Recall Readiness – Rapid Traceability & Response
- Recipe Formulation – Product & Process Design
- Recipe Management – Master Recipes & Control
- Recipe Scaling & Basis
- Recipe Versioning – Change Control for Formulas
- Record Retention – Data Integrity & Archival
- Release Status (Hold/Release) – QA Disposition
- Returns (RMA) – Reverse Logistics & Quality
- Rework – Controlled Reprocessing
- Rework Traceability – Controlled Re-Use
- Risk Management (QRM) – Risk Register & Controls
- Root Cause Analysis (RCA)
- Routing – Operation Sequence & Resources
S
- Sampling – Statistical & GMP Sampling Plans
- Serial Shipping Container Code (SSCC)
- Serialization – Unit/Case/Pallet Identification
- Shelf-Life & Expiry Dating
- Shipping Manifest
- SQF Edition 9 – Traceability & Mass Balance
- Stability Studies – Product Shelf-Life Evidence
- Standard Deviation (SD)
- Standard Operating Procedure (SOP)
- Statistical Process Control (SPC)
- Supervisory Control & Data Acquisition (SCADA)
- Supplier Corrective Action Request (SCAR)
- Supplier Qualification – Approval & Monitoring
- Supplier Quality Management (SQM)
- Supplier Verification of COAs
T
- Tare Weight
- Temperature Mapping
- Test Method Validation (TMV)
- Tests – Laboratory Analyses & Review
- Therapeutic Goods Administration (TGA)
- Therapeutic Goods Orders (TGO)
- Tolerable Negative Error (TNE)
- Total Productive Maintenance (TPM)
- Traceability – End-to-End Lot Genealogy
- 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)