Validation Terminology

A list of common validation terminology. A list of Frequently Asked Questions about validation is also available.

Actual Result – What a system does when a particular action is performed

Deliverable – A tangible or intangible object produced as a result of project execution, as part of an obligation. In validation projects, deliverables are usually documents.

Deviation – When a system does not act as expected

End-User – A person who uses the validated system

Expected Result – What a system should do when a particular action is performed

Protocol – A collection of Test Cases, used to document the testing of a system

Qualification – A testing protocol which designates that a system meets a particular collection of requirements. An Installation Qualification ensures that a system has been properly installed. An Operational Qualification demonstrates that a system functions as expected in a controlled environment. A Performance Qualification verifies that a system works under real-life conditions.

Quality Assurance – Members of the organization who are tasked with ensuring the quality of materials produced at that organization. GxP organizations are required to have robust and independent Quality Assurance operations. Depending on the organization, this group may be titled Quality Control or Quality Organization; other organizations have multiple groups dedicated to quality with their own distinct missions.

Requirement – Something a system must be able to do

Retrospective Validation – Validation of an existing system. Retrospective validations are usually performed in response to a new need for a system to be compliant or an identified gap in GxP compliance.

Specification – A document outlining the requirements for a system. Specifications are usually sub-divided into User Requirements Specifications, Functional Requirements, and Design Specifications.

System – Object or process undergoing validation. In these pages, system is intended to be a generic term, meaning computer system, equipment, method or process to be validated.

System Owner – The individual who is ultimately responsible for a system

Test Case – A documented procedure, used to test that a system meets a particular requirement or collection of requirements

Test Plan – A general testing methodology established to ensure that a system meets requirements. A Test Plan can also refer to the collection of protocols or qualifications used to test and document that a system meets requirements.

Test Step – An individual line of a Test Case. Each Test Step should include instructions, an expected result, and an actual result.

Traceability – The ability to ensure that requirements outlined in the specifications have been tested. This is usually recorded in a Requirements Traceability Matrix.

Validation – A documented process, testing a system to demonstrate and ensure its accuracy, reliability, and consistent intended performance

Validation Package – A collection of documents produced during a validation project

Common Validation Acronyms

CC – Change Control
DS – Design Specification
FAT – Factory Acceptance Testing
FS – Functional Specification
FRS – Functional Requirement Specification (See Functional Specification)
GCP – Good Clinical Practice, a collection of quality guidelines for clinical operations
GLP – Good Laboratory Practice, a collection of quality guidelines for pharmaceutical laboratory operations
GMP – Good Manufacturing Practice, a collection of quality guidelines for pharmaceutical manufacturing operations
GxP – An abbreviation combining GCP, GLP, and GMP. Sometimes also called cGxP, Current Good Practices
IQ – Installation Qualification
IOPQ – Installation/Operational/Performance Qualification
IOQ – Installation/Operational Qualification
PQ – Performance Qualification
OPQ – Operational/Performance Qualification
OQ – Operational Qualification
RTM – Requirement Traceability Matrix
SAT – Site Acceptance Testing
SDS – Software Design Specification (See Design Specification)
Spec – Specification
TM – Traceability Matrix
UAT – User Acceptance Testing
URS – User Requirement Specification
VMP – Validation Master Plan
VP – Validation Plan

Validation Document Resources