21CFR

Requirements for electronic signatures and electronic record systems used by FDA and related suppliers or distributors

Acceptance testing

Formal testing with respect to user needs, requirements, and business processes conducted to determine whether or not a system satisfies the acceptance criteria and to enable the user, customers or other authorized entity to determine whether or not to accept the system [IEEE 610.12]

Behavior-driven testing

Testing based on the behavior of a component or system to a set of input values and preconditions

Black box testing

Functional or non-functional testing without reference to the internal structure of the component or system

Business Analysis

Investigation into the operations of a business to expose the causes behind the results achieved, and the effects of those results on the business

CMMI

A framework that describes the key elements of an effective product development and maintenance process. The Capability Maturity Model Integration covers Best-Practices practices for planning,engineering and managing product development and maintenance. CMMI is the designated successor of the CMM. (Capability Maturity Model)

Design Qualification (DQ)

Documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.

Equivalence (class) partitioning

Black box test design technique in which test cases are designed to execute representatives from equivalence partitions.

ERP

Enterprise Resource Planning system.

Exploratory testing

Informal test design technique where that the tester actively controls the design of the tests as those tests are performed and  information gained while testing to design new and better tests [Bach 04]

FDA

US Food and Drug Administration

FRA

Functional Risk Assessment

GAMP

Good Automated Manufacturing Practice

GxP Regulation

The underlying international pharmaceutical requirements, such as those set forth in the US FD&C Act, US PHS Act, FDA regulations, EU Directives, Japanese regulations, or other applicable national legislation or regulations under which a company operates. These include but are not limited for:

• Good Manufacturing Practice (GMP) (pharmaceutical, including Active Pharmaceutical Ingredient (API), veterinary, and blood)
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Distribution Practice (GDP)
• Good Quality Practice (GQP)
• Good Pharmacovigilance Practice
• Medical Device Regulations
• Prescription Drug Marketing Act (PDMA)

Hazard

The potential source of harm [ISO/IEC Guide 51]

ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IEEE

Institute of Electrical and Electronics Engineers association

Installation Qualification (IQ)

Documented verification that a system is installed according to written and pre-approved specifications

Integration testing

Testing performed to expose defects in the interfaces and in the inter-actions between integrated components or systems

IRA

Initial Risk Assessment

IREB

International Requirements Engineering Board

ISO

International Organization for Standardization

ISTQB

International Software Testing Qualifications Board

Operational Qualification (OQ)

Documented verification that a system operates according to written and pre-approved specifications throughout specified operating ranges

Performance Qualification (PQ)

Documented verification that a system is capable of performing the activities of the processes it is required to perform, according to written and pre-approved specifications, within the scope of the business process and operating environment

PIC/S

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

QSR

Quality System Regulations

RAM

Requirements Abstraction Model comprises four abstraction levels developed as a response to the industrial need. The model allows for placement of requirements on different levels and supports abstraction or break down of requirements to make them comparable to each other

Risk

A factor that could result in future negative consequences; usually expressed as impact and likelihood

Safety

The capability of the software product to achieve acceptable levels of risk of harm to people, business,software, property or the environment in a specified context of use. [ISO 9126]

SAP

Germam company for Business Management and Software Solutions Applications and Services

System testing

The process of testing and integrated system to verify that it meets specified requirements [Hetzel  88]

TPI

Test Process Improvement. A continuous framework for test process improvement that describes the key elements of an effective test process, especially targeted at system testing and acceptance testing

Unit testing

Also called: component testing. The testing of individual software components [IEEE 610.12]

Validation Plan

Document describing how to ensure compliance and fitness for intended use of specific systems. They specify scope, approach, resources, roles and responsibilities. and the types and extent of activities,tasks, and deliverables

Validation Report

Document summaring the activities performed, any deviations from the validation plan, any outstanding and corrective actions, and providing a statement of fitness for intended use of the system

White box testing

Testing based on an analysis of the internal structure of the component or system