ולידציה – GAMP – Definition of Terms

Good Automated Manufacturing Practice (GAMP) Definition of Terms

Definition of Terms Used in Testing Environments

This document provides a definition of a set of testing terms used within pharmaceutical and other life sciences (consistent with those used in GAMP 4), Information Technology (IT) industries, and control and automation industries, in order to facilitate understanding testing environments.

It is recommended that a definition of consistent testing terms should be prepared on an organizational or project basis, where members of User and Supplier organizations work together. It is helpful to agree on these testing terms definition prior to contract signing, to ensure that contractual issues are based on common understanding of activities and milestones.

:The definition of terms listed below is based on three sources

GAMP 4 Definition from the GAMP Guide for the Validation of Automated Systems

IEEE Definition from IEEE 100, the Authoritative Dictionary of IEEE Standard Terms

BCS Definition from Working Draft: Glossary of terms used in software testing, version 6.2, produced by the British Computer Society Interest Group in Software Testing – BCS SIGIST

Terms and Definitions

Terminology Definition Source
Acceptance Criteria Criteria that a system or component must satisfy in order to be accepted by the User, customer or other authorized entity  GAMP 4 , IEEE
Acceptance Test

Formal testing conducted to determine whether or not a system satisfies its acceptance criteria, and to enable the customer to determine whether or not to accept the system

See also Factory Acceptance Test (FAT) and
Site Acceptance Test SAT

 ,GAMP 4 IEEE
Black Box Testing See Functional Testing IEEE
Boundary Condition Testing Testing for correct operation when one or more variables are at a limiting value or a value at the edge of the domain of interest IEEE
Calibration Set of operation that establish, under specified conditions, the relationship between values indicated by a measuring instrument or system, or values represented by a material measure or a reference material, and the corresponding values of a quantity realized by a reference standard  GAMP 4,   ISO 10012

 

 

Terminology Definition Source
Challenge Testing Testing to check system behavior under abnormal conditions. Can include stress testing and deliberate challenges, e.g., to the security access system, data formatting rules, possible combinations of operator’s actions, etc
Commissioning Process of providing to the appropriate components the information necessary for the designed communication between them IEEE
Emulation A model that accepts the same inputs and produces the same outputs as the given system IEEE
Environmental Testing Testing that evaluates system or component performance up to the specified limits of environmental parameters, e.g., temperature, humidity or pressure
Firmware FW Combination of hardware (HW) device, computer instructions and data that reside as read-only software (SW) on that device IEEE
Factory Acceptance Test FAT

Acceptance Test in the Supplier’s Factory, usually involving the customer

See also Factory Acceptance Contrast to Site Acceptance Test – SAT

GAMP 4 , IEEE
Functional Testing Testing that ignores the internal mechanism of a system or component, and focuses solely on the outputs generated in response to input and execution conditions
Also known as Black Box Testing
GAMP 4 , IEEE
Hardware- HW

Physical equipment used to process, store, or transmit computer programs or data

Physical equipment used in data processing, as opposed to programs, procedures, rules, and associated documentation

IEEE
HW Testing Testing carried out to verify the correct operation of system HW independent of any custom application SW IEEE
Installation Qualification – IQ Documented verification that a system is installed according to written and pre-approved specifications  GAMP 4 , IEEE
Integration

Process of combining SW components, HW components, or both, into an overall system

Sometimes described as SW Integration and System Integration, respectively

IEEE

 

Terminology Definition Source
Integration Testing

(1) Testing in which SW components, HW components, or both, are combined and tested to evaluate the integration between them

(2) Orderly progression of testing of incremental pieces of the SW program, in which SW elements, HW elements, or both, are combined and tested until the entire system has been integrated to show compliance with the program designed, and the system capabilities and requirements

IEEE
Instance Single installation of a SW application (plus associated databases, tools and utilities). Usually applied to configurable IT systems
Load Testing Stress testing conducted to evaluate a system or component up to the limits of its specified requirements
Loop Testing Testing in which control system inputs and outputs are exercised and their functionality verified
Market Requirements Specification Statement of generic industry requirements used by the Supplier as an input to its product development life cycle IEEE
Middleware Combination of HW, computer instructions and data that provides infrastructure used by other system modules IEEE
Module Testing Testing of individual HW or SW components, or groups of related components IEEE
Negative Testing Testing aimed at showing that the SW does not work BCS
Operational and Support Testing

(1) Testing conducted to evaluate a system or component in an operational environment

(2) All testing required to verify system operation in accordance with design after the major component is energized or operated

IEEE
Operation Qualification- OQ Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating range GAMP 4 , IEEE
Performance Qualification – PQ Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, whilst operating in its specified environment GAMP 4 , IEEE
Positive Testing Testing aimed at showing that the SW does meet the defined requirements BCS

 

 

Terminology Definition Source
Qualification Process to demonstrate the ability to fulfill specified requirements

GAMP 4

  ISO

Simulation A model that behave or operates like a given system when provided a set of given inputs IEEE
Site Acceptance Test – SAT

Acceptance Test at the customer’s Site, usually involving the customer

See also Factory Acceptance Contrast to Site Acceptance Test – SAT

GAMP 4,

IEEE

Software – SW Computer programs, procedures, and associated documentation and data pertaining to the operation of a computer system IEEE
Stress Testing Testing conducted to evaluate a system or component at or beyond the limits of its specified requirements IEEE
Structural Testing Examining the internal structure of the source code. Includes the low-level and high-level code review, path analysis, auditing of programming procedures, and standards actually used, inspection for extraneous “dead code”, boundary analysis and other techniques. Requires specific computer science and programming expertise
Also known as White Box Testing
GAMP 4
Supplier Organization or person that provides a product   GAMP 4,  ISO
System Testing Testing conducted on a complete, integrated system to evaluate its compliance with its specified requirements GAMP 4
Test

 Procedure in which by executes an activity under specified conditions, the results are observed and recorded, and an evaluation is made of some aspect of that system or component

 Determination of one or more characteristics according to a procedure

,GAMP 4

ISO

GAMP 4

 IEEE

Test Case Set of test inputs, execution conditions and expected results developed for a particular objective, such as to exercise a particular program path or to verify compliance with a specific requirement

GAMP 4 ,

 IEEE

Test Plan Document describing the scope, approach, resources and schedule of intended activities. It identifies test items, features to be tested, testing tasks, personnel en charged of each task, and risks requiring contingency planning GAMP 4

 

Terminology Definition Source
Test Procedure Detailed instructions for the setup, execution and evaluation of results for a given test case GAMP 4,   IEEE
Test Protocol See Test Specification IEEE
Test Script Documentation that specifies a sequence of actions for executing a given test GAMP 4 , IEEE
Test Specification Document describing the scope, management, use of procedures, sequencing, test environment, and prerequisites for a specific phase of testing
Test Strategy See Test Plan
Unit Testing Testing of individual HW or SW units or groups of related units IEEE
Usability Testing Testing the ease with which Users can learn and use a product BCS
User Person or persons who operate or interact directly with the system GAMP 4
Validation Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes GAMP 4 , FDA
Verification Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled GAMP 4 ,    ISO
White Box Testing See Structural Testing IEEE