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.
References in periodicals archive ?
He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.
SOFTWARE VALIDATION SOPs Non-Product Computer Systems Validation SOP (main) Training SOP 21 CFR Part 11 SOP Disaster Recovery SOP Backup and Recovery SOP Validated Systems Administration SOP Incident (Deviation) Reporting SOP Retrospective Validation SOP Validation Protocol Development SOP Validated Systems Change Control SOP Custom Software Development SOP Validation Risk Assessment SOP Supplier Audit (Vendor Assessment) For Validated Validation Systems SOP Testing SOP System Security For Validated Systems SOP CAPA/NC Management For Validated Systems SOP Validation Reporting SOP Data Migration For Validated Systems Validation Document Control SOP Table 1: The minimum standard operating procedures needed for software validation.
If you do not have one, it is highly recommended that you develop one for software validation.
The new guidance describes how certain provisions of the medical device Quality System Regulation (QSR) apply to software, and the FDA's current approach to evaluating a software validation system.
While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.
The term "green validation" refers to a new, more responsible approach to software validation that leverages GAMP methodologies and advanced technologies to promote a paperless validation environment.
Given the impact of ERP systems on financial, manufacturing, and business processes, risk is an important consideration for software validation of these systems.
This article summarizes the requirements for effective validation and summarizes what it will take to master software validation within your organization.

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