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Why Can’t I Just Purchase Validation Documentation?The FDA requires verification and validation activities cover how a system is configured in the customer’s environment so there is no one-size-fits-all validation.Below are eight of the most common systems, all of which fall under FDA regulation as well as ISO and SOX control.
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Understanding the actual guidelines and best practices for meeting these requirements isn’t always clear and, as a result, your software may be compliant but you may not be.
This article provides answers to the top five most common software validation and documentation questions asked by others in FDA-regulated industries and demonstrates best practices for meeting the guidelines. The FDA mandates software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.
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The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions.The following documents are what auditors like to see in a Quality System Validation: Software Validation Protocol; Network Diagram; Software Requirements Specification; Risk Analysis (the GAMP standard template is recommended); Part 11 Compliance Analysis; Design Specification (only for systems or areas of the system which contain custom code such as integrations between your Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems) ; Test Plan; Test Specifications/Test Cases; and a Final Validation Report.These documents may be combined so long as you capture all of the information.Here’s what you need to know: If you’d like to learn more about medical device software validation, start with International Technical Commission (IEC) 62304 — the validation standards of most countries are based on this document, which outlines development life cycle standards for medical software.If you’re interested in the pharmaceutical industry’s validation standards, Good Automated Manufacturing Practice (GAMP), visit the International Society for Pharmaceutical Engineering (ISPE) GAMP resources page.Select an edition below to learn more, or download the free 30-day trial to explore all of Bar Tender’s features and see how it can solve your toughest needs for labeling, barcoding and more.Tags: Adult Dating, affair dating, sex dating