ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Traceability

The degree to which each element in a software development product establishes its reason for existing; e.g., the degree to which each element in a bubble chart references the requirement that it satisfies.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Traceability Analysis Traceability Matrix

Traceability

A prerequisite for trustworthy records, apart from data security. Traceability is the part of the laboratory data system audit trail that holds the evidence of who did what to a record and when.

Traceability

(ISO) Ability to trace the history, application or location of that which is under consideration.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Traceability

(IEEE) The degree to which a relationship can be established between two or more products of the development process, especially products having a predecessor-successor or master-subordinate relationship to one another; e.g., the degree to which the requirements and design of a given software component match.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Consistency

Traceability

The ability to link a user requirement specification through functional specifications and design specifications to test cases. It should be possible to look at a specification and determine how it was tested, or to look at a test and determine what specifications it challenges.

Publication Source: GAMP® Good Practice Guide: Global Information Systems Control and Compliance

Publication Date: 2005

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