Glossary
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Failure mode effects analysis (FMEA )
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Systematic tool used to identify: (1) effects of a potential product/service's failure. (2) methods to eliminate or reduce the chances of a failure.
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FDA 21 CFR Part 11
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FDA rule defining criteria for acceptable electronic records and signatures.
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FDA 21 CFR Part 820
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Also known as the Quality System Regulation, it ensures that finished devices will be safe and effective for people to use.
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Financial Compliance Vendors
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Companies that sell Compliance Software
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FSA Personnel Compliance Software
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Compliance Software that ensures personnel systems comply with FSA regulations.
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FSA
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Regulations Regulations created by the Financial Services Authority (FSA). The FSA is a company (limited by guarantee) that regulates the financial services industry in the United Kingdom. It is an independent, non-governmental, quasi-judicial body.
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