software validation


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Related to software validation: Software verification

software validation

The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often performed by a third party consulting organization.
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References in periodicals archive ?
Both of the last two differences in the chart use the phrase, "a clear set of detailed requirements." This is the most crucial element for proper software validation, and one that is frequently neglected.
* Have more than one internal expert involved in the mapping and review processes and do not rely solely on software validation.
SACEM software validation. In Proceedings of the 12th IEEE International Conference on Software Engineering (Nice, France, Mar.
* Multiple hosting options--Cloud or on-premise solutions reduce issues associated with software validation)
Software validation company ValGenesis Inc reported on Tuesday that it has received the first patent for the paperless validation lifecycle process from the US Patent and Trademark Office (USPTO).
- Usability, software validation and risk management evaluation
Many organizations view software validation as a necessary evil and sometimes sidestep requirements to meet business goals.
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm085371.pdf
FDA Guidelines 21 CFR 820.3(z) and (aa) and 820.30(f) and (g) define medical device software validation as "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended use, and that the particular requirements implemented through software can be consistently fulfilled."
However, an Association for the Advancement of Medical Instrumentation (AAMI) workgroup has been formed to write a technical information report on the topic of software validation for regulated automated process software.
In addition, Cobham's OBC Reference Design features extensive software support including; board support package, boot software, peripheral drivers and a path for software validation. The reference design can be leveraged on its own or easily interface to a broader system that includes an FPGA.

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