Pharma braces for new regulations that test ERP's quality, manufacturing tools
In November 2013, legislators initially introduced the Drug Quality and Security Act (DQSA) - a proposed law that would include the Compounding Quality Act and the Drug Supply Chain Security Act. The first sets up a voluntary compliance arrangement for pharmaceutical firms and the other requires the FDA to develop a national track-and-trace system that manufacturers must use when introducing products into the supply chain.
The bill was signed into law in 2013, but manufacturers had until January 2015 to implement portions of the required labeling, tracking, and paperwork. A company's ability to meet those standards will depend in large part on the capabilities of their existing ERP system.