Please also see your list of Frequently Asked Questions about validation.
Actual Result - What a system does when a particular action is performed.
Deliverable - a tangible or intangible object produced as a result of project execution, as part of an obligation. In Validation Projects, Deliverables are usually documents.
Deviation - When a system does not act as expected.
End User - Personnel who use the validated System.
Expected Result - What a system should do when a particular action is performed.
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Protocol - A collection of Test Cases, used to document the testing of a system.
Qualification - A testing protocol which designates that a system meets a particular collection of requirements. An Installation Qualification ensures that a system has been properly installed. An Operational Qualification demonstrates that a system functions as expected in a controlled environment. A Performance Qualification verifies that a system works under real-life conditions.
Quality Assurance - Members of the organization who are tasked with ensuring the quality of materials produced at that organization. GxP organizations are required to have robust and independent Quality operations. Depending on the organization, this group may be titled Quality Control or Quality Organization; other organizations have multiple groups dedicated to quality with their own distinct missions.
Requirement - Something that a system must be able to do.
Retrospective Validation - Validation of an existing system. Retrospective validations are usually performed in response to
a new need for a system to be compliant or an identified gap in GxP compliance. Specification - A document outlining the requirements for a system. Specifications are usually sub-divided into User Requirement Specification, Functional Requirements and Design Specification.
System - Object or process undergoing validation. In these pages, System is intended to be a generic term, meaning Computer System, Equipment, Method or Process to be validated.
System Owner - The individual who is ultimately responsible for a System.
Test Case - A documented procedure, used test that a system meets a particular requirement or collection of requirements.
Test Plan - A general testing methodology established to ensure that a system meets requirements. A Test Plan can also refer to the collection of Protocols or Qualifications used to test and document that a system meets requirements.
Test Step - An individual line of a Test Case. Each Test Step should include instructions, an expected result and an actual result.
Traceability - The ability to ensure that requirements outlined in the specifications have been tested. This is usually recorded on a Traceability Matrix.
Validation - A documented process, testing a system to demonstrate and ensure its accuracy, reliability and consistent intended performance.
Validation Package - A collection of documents produced during a validation project
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Common Validation Acronyms
Validation Document Resources
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