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 |
,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 |
