Validation Compliance Annual: 1995
CRC Press, 17. feb. 1995 - 1200 sider
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
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abbreviated acceptance accordance action activities addition adequate Administration agency analysis application appropriate approved areas audit authorized automated batch blood body clinical collection complete compliance components concern conducted considered contain copy corrective described determine Directive documentation donor drug product effectiveness electronic ensure equipment established evaluation facility failure firm Food functions human identified indicate individual initial inspection intended investigation issues labeling laboratory limited listed maintained manufacturer marketing materials means medical devices meet methods necessary notified operation performed period person personnel practice prevent problems procedures proposed protocol quality assurance reason records reference regulations relating request requirements responsible safety samples signature specifications sponsor standards storage submitted substance tion unit validation written