21CFRRequirements for electronic signatures and electronic record systems used by FDA and related suppliers or distributors
Acceptance testingFormal 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 testingTesting 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 AnalysisInvestigation into the operations of a business to expose the causes behind the results achieved, and the effects of those results on the business
CMMIA 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) partitioningBlack box test design technique in which test cases are designed to execute representatives from equivalence partitions.
ERPEnterprise 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]
FDAUS Food and Drug Administration
FRAFunctional Risk Assessment
GAMPGood 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)
HazardThe potential source of harm [ISO/IEC Guide 51]
ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IEEEInstitute of Electrical and Electronics Engineers association
Installation Qualification (IQ)Documented verification that a system is installed according to written and pre-approved specifications
Integration testingTesting performed to expose defects in the interfaces and in the inter-actions between integrated components or systems
IRAInitial Risk Assessment
IREBInternational Requirements Engineering Board
ISOInternational Organization for Standardization
ISTQBInternational 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

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

QSRQuality System Regulations
RAMRequirements 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
RiskA factor that could result in future negative consequences; usually expressed as impact and likelihood
SafetyThe 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]
SAPGermam company for Business Management and Software Solutions Applications and Services
System testingThe process of testing and integrated system to verify that it meets specified requirements [Hetzel  88]
TPITest 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 testingAlso called: component testing. The testing of individual software components [IEEE 610.12]
Validation PlanDocument 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 testingTesting based on an analysis of the internal structure of the component or system