CSV, CSA and GMP Automation Glossary
Short definitions for validation, QA and automation terms used across the GXPLearn.io training platform.
- CSV
- Computer System Validation — demonstrating through documented lifecycle activity that automated systems are fit for intended use under GMP. Explore in GXPLearn.io training →
- CSA
- Computer Software Assurance — risk-based software assurance emphasising critical thinking, intended use and proportionate evidence. Explore in GXPLearn.io training →
- 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 →
- Audit trail
- Secure, time-stamped record of who changed what in a system — essential for investigations, data integrity and GMP review. 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 →
- Change control
- Formal process to assess, approve and implement changes to validated systems with traceable impact on GxP state. Explore in GXPLearn.io training →
- Validation evidence
- Documented proof that requirements are met — specifications, test results, traceability and summary reports reviewers can follow. Explore in GXPLearn.io training →
- Risk-based testing
- Scoping verification and validation effort according to risk, intended use and potential impact on patient safety and product quality. Explore in GXPLearn.io training →
- Data integrity
- Ensuring data is attributable, legible, contemporaneous, original and accurate (ALCOA+) throughout its lifecycle. Explore in GXPLearn.io training →
- ALCOA+
- Data integrity principles — Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring and Available. 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 →