What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.
fda approval guidelines
supports its mission, the FDA has defined Good Manufacturing Practices (GMPs) . Originally, GMPs were based upon the best practices of the industry. As technology and practices improved, the GMPs evolved as well. In the U.S., drug GMPs were formally introduced in 1963 and significantly rewritten in the 1970s. GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to GMPs are safe, properly