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The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.
The rules may be implemented through the automated facilities of a data dictionary, or by the inclusion of explicit application program validation logic of the computer and its application. This is distinct from formal verification , which attempts to prove or disprove the correctness of algorithms for implementing a specification or property.
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000. The words "verification" and ...
If a regulated firm keeps "hard copies" of all required records, those paper documents can be considered the authoritative document for regulatory purposes, and the computer system is not in scope for electronic records requirements—though systems that control processes subject to predicate rules still require validation. [5]
An example of a data-integrity mechanism is the parent-and-child relationship of related records. If a parent record owns one or more related child records all of the referential integrity processes are handled by the database itself, which automatically ensures the accuracy and integrity of the data so that no child record can exist without a parent (also called being orphaned) and that no ...
A requirement is that both the system data and model data be approximately Normally Independent and Identically Distributed (NIID). The t-test statistic is used in this technique. If the mean of the model is μ m and the mean of system is μ s then the difference between the model and the system is D = μ m - μ s. The hypothesis to be tested ...
“The rest of the world is cracking down on the internet even faster than the U.S.,” Goldman said. “So we’re a step behind the rest of the world in terms of censoring the internet.
The security policy must be explicit, well-defined, and enforced by the computer system. Three basic security policies are specified: [6] Mandatory Security Policy – Enforces access control rules based directly on an individual's clearance, authorization for the information and the confidentiality level of the information being sought. Other ...