SYSPRO ERP solution support pharmaceutical manufacturers to new FDA regulation

SYSPRO, the leading provider of visionary, pragmatic ERP software, today announced that the company is highly confident that the SYSPRO ERP solution will enable pharmaceutical manufacturers to meet the new U.S. Food and Drug Administration (FDA) regulations being proposed by Congress. The Drug Safety and Accountability Act of 2010 will strengthen quality pharmaceutical standards with stringent oversight on suppliers, manufacturers and their supply chains. The bill would require manufacturers to establish additional procedures to ensure the quality of safety drugs and drug components. It also would require companies to document the components in the drug manufacturing supply chain. The new Act is follow-through on the part of FDA executives who promised to strengthen inspection and quality requirements for drug makers who outsource to suppliers. As a result of these changes, many pharmaceutical manufacturers are looking to companies like SYSPRO to supply them with ERP systems to facilitate both the management and meeting of these new standards.

“Safety remains a serious concern, and SYSPRO will continue efforts to enable its software to assist customers by providing users greater visibility and control over quality and tracking in industries such as food, medical devices and pharmaceuticals, where quality and regulatory conformance are particularly crucial.”

Traceability functionality is the key component required to assist in the meeting of these new standards. SYSPRO ERP software offers extensive traceability capabilities as well as other functionalities that facilitate the ability of manufacturers to trace products from origin, through the manufacturing process, to their ultimate destination, fully maintaining assurance certification and tracking expiration dates.

SYSPRO optionally allows specific traceable components to be reserved for specific work-orders, as well as providing the flexibility of specifying the parent traceable numbers at the beginning, during or the end of the manufacturing process.

SYSPRO lot traceability and serial tracking functionality afford extensive visibility up or down the chain, as well as providing specific component to parent tracking, thereby providing the means to expedite recalls, should the need arise. In fact, so extensive are the traceability aspects inherent in SYSPRO software that they extend to Landed Cost Tracking, which provides visibility of imported goods and tracks all associated cost, which is another area to which the FDA is applying more stringent regulations.

According to SYSPRO USA President Joey Benadretti, "Safety remains a serious concern, and SYSPRO will continue efforts to enable its software to assist customers by providing users greater visibility and control over quality and tracking in industries such as food, medical devices and pharmaceuticals, where quality and regulatory conformance are particularly crucial."