Unified Software Platform Responds to FDA cGMP Guidelines

12/29/2004

Datasweep, Inc. (San Jose, Calif.), has introduced a control platform that offers pharmaceutical manufacturers comprehensive and unified support for the FDA's emerging Current Good Manufacturing Practices (cGMPs).

Pharmaceutical companies facing stringent regulatory and product supply challenges will benefit from the software's ability to span multiple manufacturing sites, tightly integrate quality management procedures with operations and IT, and reduce the overall cost of FDA compliance. The integrated solution allows manufacturers to reduce the number of separate systems required to support quality and manufacturing while significantly improving visibility, information accuracy and manufacturing process control.

"Datasweep is... the first software company to consolidate quality assurance, operational and quality control, compliance, and global best practices into one system for customers with both batch and discrete manufacturing processes," said Keith Chambers, Life Sciences Director at Datasweep. "Our enterprise-class system gives customers a range of platform choices that synchronize with their ERP investments -- everything from Windows to HP/UX to Linux -- simplifying deployment and maintenance. Integration with other enterprise applications is critical, and we continue to collaborate with SAP and other leading technology vendors to promote open integration standards, such as J2EE and S95."