Solution Meets FDA Standards For Electronic Signature Capture

Compiled By Traci Purdum In order to reap the benefits for electronic records and signatures, pharmaceutical companies must comply with U.S. Food and Drug Administration (FDA) regulations, specifically 21 Code of Federal Regulations (CFR) Part 11. With this in mind, LIS, a global provider of supply-chain execution solutions, has released version 7.3 of its warehouse management system, Dispatcher-WMS. This latest version complies with the FDA regulations concerning electronic records and electronic signatures. "The advent of supply-chain execution solutions has allowed pharmaceutical companies to provide increased access to information, as well as move to a more cost-effective paperless environment," says Bob Carver, vice president of marketing for LIS. "While there are huge benefits, great care regarding electronic records and signatures must be taken, and this means full compliance with the FDA's 21 CFR Part 11." Under 21 CFR Part 11, which was implemented to reduce fraud, nearly everything is affected, including the receiving of ingredients and raw materials, manufacturing and the final distribution to the customer.

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