academy

Glossary


Failure mode effects analysis (FMEA )
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.
FDA 21 CFR Part 11
FDA rule defining criteria for acceptable electronic records and signatures.
FDA 21 CFR Part 820
Also known as the Quality System Regulation, it ensures that finished devices will be safe and effective for people to use.
Financial Compliance Vendors
Companies that sell Compliance Software
FSA Personnel Compliance Software
Compliance Software that ensures personnel systems comply with FSA regulations.
FSA
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.