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 se…
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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…