GxP, GMP & Validation Glossary

Validation fundamentals

CSV

Computer System Validation — demonstrating through documented lifecycle activity that automated systems are fit for intended use under GMP. What is CSV? — Full guide → Explore in GXPLearn.io training →

CSA

Computer Software Assurance — risk-based software assurance emphasising critical thinking, intended use and proportionate evidence. What is CSA? — Full guide → Explore in GXPLearn.io training →

CSV vs CSA

Two complementary lenses on the same GMP obligation — CSV provides lifecycle structure and traceability; CSA proportiones assurance effort on production and QMS software by process risk. CSV vs CSA — Full guide → Explore in GXPLearn.io training →

Risk-based testing

Scoping verification and validation effort according to risk, intended use and potential impact on patient safety, product quality and data integrity. What is CSA? — Full guide → Explore in GXPLearn.io training →

Validation planning & requirements

Validation plan

A validation plan defines how a computerised system will be validated — scope, approach, roles, risk rationale, deliverables, testing strategy and traceability before IQ, OQ or PQ protocols are executed. Validation plan — Full guide → Explore in GXPLearn.io training →

URS

User Requirements Specification — documents intended system behaviour from the process and quality perspective with testable requirements that anchor validation planning, traceability and qualification evidence. URS guide — Full guide → Explore in GXPLearn.io training →

FRS

Functional Requirements Specification — translates user requirements into functional system behaviour to be implemented, verified through design outputs and tested during qualification. URS guide — Full guide → Explore in GXPLearn.io training →

Traceability matrix

A traceability matrix links requirements to design specifications and test evidence — making coverage visible so reviewers can verify every requirement has corresponding qualification proof. V-Model validation — Full guide → Explore in GXPLearn.io training →

V-Model

A lifecycle diagram mapping specification layers on the left (user requirements, functional requirements, design) to verification and validation activities on the right (installation checks, operational testing, intended-use confirmation). V-Model validation — Full guide → Explore in GXPLearn.io training →

Qualification

IQ

Installation Qualification — documented verification that a system is installed according to approved specifications, including versions, configuration baselines and environment checks before functional testing. IQ, OQ & PQ explained — Full guide → Explore in GXPLearn.io training →

OQ

Operational Qualification — documented verification that a system operates as intended across defined operating ranges under controlled test conditions, with acceptance criteria, observed results and deviation handling. IQ, OQ & PQ explained — Full guide → Explore in GXPLearn.io training →

PQ

Performance Qualification — documented verification that a system performs reliably in production-like or intended-use conditions, confirming operational performance with procedures, batches or site expectations. IQ, OQ & PQ explained — Full guide → Explore in GXPLearn.io training →

Validation frameworks

GAMP 5

ISPE's risk-based framework for compliant GxP computerised systems. Software categories (1, 3, 4, 5) help teams scale validation effort, leverage suppliers and align testing with patient safety and data integrity risk. GAMP 5 categories — Full guide → Explore in GXPLearn.io training →

Data integrity

Data integrity

Ensuring GMP data is attributable, legible, contemporaneous, original and accurate (ALCOA+) throughout its lifecycle — the foundation for trustworthy batch records, audit trails and release decisions. What is data integrity? — Full guide → Explore in GXPLearn.io training →

ALCOA+

Data integrity principles — Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring and Available. What is data integrity? — Full guide → Explore in GXPLearn.io training →

Audit trail

Secure, time-stamped record of who changed what in a system — essential for investigations, data integrity and GMP review. What is data integrity? — Full guide → Explore in GXPLearn.io training →

Regulations

Part 11

21 CFR Part 11 — the US FDA regulation governing electronic records and electronic signatures, requiring controls for access, audit trails and validation evidence where predicate rules apply. What is CSA? — Full guide → Explore in GXPLearn.io training →

Annex 11

EU GMP Annex 11 — guidance for computerised systems in pharmaceutical manufacturing, covering validation, data integrity, access control and change management throughout the system lifecycle. Validation lifecycle — Full guide → Explore in GXPLearn.io training →

Lifecycle & evidence

Change control

Formal process to assess, approve and implement changes to validated systems with traceable impact on GxP state. Validation lifecycle — Full guide → Explore in GXPLearn.io training →

Validation evidence

Documented proof that requirements are met — specifications, test results, traceability and summary reports reviewers can follow. Validation lifecycle — Full guide → Explore in GXPLearn.io training →

Automation & manufacturing

GMP

Good Manufacturing Practice — quality system requirements for medicines manufacturing, including documented control of processes and systems. Explore in GXPLearn.io training →

GxP

Collective term for Good Practice quality guidelines (GMP, GCP, GLP, etc.) governing regulated life-science activities. Explore in GXPLearn.io training →

DeltaV

A commercial DCS platform. GXPLearn.io uses DeltaV-style educational simulations — not a licensed DeltaV product or emulator. Explore in GXPLearn.io training →

ISA-88

Batch control standard defining hierarchical recipe models (procedure, unit procedure, operation, phase) for repeatable manufacturing. Explore in GXPLearn.io training →

Recipe

Structured batch instructions defining process organisation, parameters and execution logic coordinated at runtime by batch services. Explore in GXPLearn.io training →

Phase

The lowest executable batch object in ISA-88 — acts on equipment, reports status and is orchestrated by higher recipe layers. Explore in GXPLearn.io training →

Unit procedure

ISA-88 layer that organises operations on a specific process unit within a wider batch procedure. Explore in GXPLearn.io training →

Equipment module

Equipment-facing control abstraction that groups devices and phases for coordinated batch execution on a unit. Explore in GXPLearn.io training →

Control module

Lowest-level control entity — typically a valve, loop or device command interface used by phases and equipment modules. Explore in GXPLearn.io training →

Batch record

Documented evidence of how a batch was executed — parameters, alarms, operator actions, sign-offs and linked electronic records. Explore in GXPLearn.io training →

Alarm

Operator notification of an abnormal condition requiring awareness or response — managed by priority, shelving and acknowledgement discipline. Explore in GXPLearn.io training →

Deviation

Departure from an approved instruction, specification or expected result — investigated for impact, root cause and corrective action. Explore in GXPLearn.io training →

Historian

Time-series data archive for process values — used in batch review, deviation support and validation evidence. Explore in GXPLearn.io training →

HMI

Human-Machine Interface — operator graphics and controls for monitoring and interacting with running batch and process equipment. Explore in GXPLearn.io training →

PLC

Programmable Logic Controller — industrial controller for discrete and sequential logic, often integrated with wider DCS architectures. Explore in GXPLearn.io training →

DCS

Distributed Control System — platform spreading real-time control across plant controllers with centralised engineering and operations. Explore in GXPLearn.io training →

SCADA

Supervisory Control and Data Acquisition — software supervising remote equipment, often paired with PLCs or DCS layers in manufacturing. Explore in GXPLearn.io training →

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