SAN JOSE, Calif.-A software platform for pharmaceutical manufacturers promises to support FDA 21st Century cGMPs by letting companies span one or multiple manufacturing sites, tightly integrate quality management procedures with manufacturing operations and IT, and reduce the cost of FDA compliance.
Keith Chambers, life sciences director at Datasweep Inc. (www.datasweep.com), says, “We are 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.”
Datasweep's pharma management software, says the company, is a response to the FDA’s Pharmaceutical cGMPs for the 21st Century-A Risked-Based Approach (see CleanRooms, December 2004, page 1), which says in part: “It has been the goal of the cGMP initiative to create a regulatory framework that will encourage pharmaceutical manufacturers to make use of these modern tools, to facilitate the implementation of robust manufacturing processes that reliably produce pharmaceuticals of high quality and that accommodate process change to support continuous process improvement.”
The Datasweep platform is designed so that pharmaceutical manufacturers can reduce the number of separate systems that are required to support quality and manufacturing, while improving visibility, information accuracy, and manufacturing process controls.
The software solutions help create and control continuous improvement processes while building detailed product history records based on production operations, supplier management, service and repair, quality management, and regulatory compliance. III