1. Data in the form of a logical path linking a sequence of events, used to trace the transactions that have affected the contents of a record. (ISO)
2. A chronological record of system activities that is sufficient to enable the reconstruction, reviews, and examination of the sequence of environments and activities surrounding or leading to each event in the path of a transaction from its inception to output of final results
A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions where those features and/or actions are both unique to that individual and measurable.
Current Good Manufacturing Practice - The basis principles, procedures and resources required to ensure an environment suitable for manufacturing products of an acceptable quality.
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
U. S. Food and Drug Administration
The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry
GxP stands for a combination of GMP, GLP and GSP
GMP - Good Manufacturing Practice
GLP - Good Laboratory Practice
GSP - Good Safety Practice
A technique used to identify conceivable failures affecting system performance, human safety or other required characteristics.
Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer's recommendations are suitably considered. (FDA)
An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system
Establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances. (FDA)
Establishing confidence that the process is effective and reproducible. (FDA)
Written procedures [prescribing and describing the steps to be taken in normal and defined conditions] which are necessary to assure control of production and processes.
A matrix that records the relationship between two or more products; e.g., a matrix that records the relationship between the requirements and the design of a given software component. (IEEE)
Used as an entity to define a procedure of review, analysis, and testing throughout the software life cycle to discover errors, determine functionality, and ensure the production of quality software. (NIST)
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