The system meets the U.S. Food and Drug Administration's 21 CFR Part 11 Validation Standard, involving controls for closed systems, electronic records and signatures, and verifiable auditing.
Highlights
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PI/VIS Revision Validation at Receipt and Putaway
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Allocation of "Ship With" PI/VIS's to Orders and Line Detail on the Packing List
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PI/VIS Management for Expiration and Ship With PI/VIS's at Product Group/Item/Lot Level
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Move to "Hold" on Expiring Lot, PI/VIS, etc. during End Of Day Process
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IRMS accommodates industry and Federal government requirements concerning the warehousing and distribution of pharmaceuticals and other such limited shelf-life products, from vaccines to food.
The system meets the U.S. Food and Drug Administration's 21 CFR Part 11 Validation Standard, involving controls for closed systems, electronic records and signatures, and verifiable auditing.
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As part of the approval process, IRMS was successfully evaluated by the FDA using Good Automated Manufacturing Process (GAMP4) standards. Additionally, IRMS meets requirements for the Federal government's Price Index/Producer Price Index (PI/PPI) revision.
Select from clients, Distribution Solutions International (pharmaceuticals), Breyers / Good Humor (ice cream) and the State of Ohio (vaccine), for more on the use of IRMS in FDA-regulated industries and environments.
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