Datasweep Delivers Unified Software Platform for Pharmaceutical Manufacturers; Responds to New FDA Guidelines for ”cGMPs for the 21st Century”
Datasweep, Inc. today announced comprehensive and unified support for the FDA’s emerging Current Good Manufacturing Practices (cGMPs) for pharmaceutical manufacturers. 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.
“Datasweep is unique in being able to supply an enterprise-class platform that meets evolving pharmaceutical requirements. 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,” 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 critically important, and we continue to collaborate with SAP and other leading technology vendors to promote open integration standards, such as J2EE and S95.”
In its final report called Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach, the FDA created a new framework for the regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches. “In recent years, significant advances in manufacturing science, quality management systems and risk management have taken place, yielding modern manufacturing tools that can be used to help ensure manufacturing quality,” states the report. “Such new tools enable manufacturers to detect, analyze, correct, and prevent problems and continuously improve their manufacturing processes. It has been the goal of the cGMP initiative to create a regulatory framework that will encourage pharmaceutical manufacturers to also 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.”
Datasweep’s integrated solutions allow pharmaceutical manufacturers to reduce the number of separate systems that are required to support quality and manufacturing while significantly improving visibility, information accuracy and manufacturing process control. The goal is the ability to achieve “perfect order” performance in drug manufacturing.
“Companies must adopt an enterprise-wide, top-down approach to regulatory compliance to ensure efficient and coordinated compliance efforts across all of the organization. In manufacturing operations, compliance should be built into operation and process capabilities, not just serving as a part of quality control activities,” said Roddy Martin, vice president of Life Sciences Research, in an AMR Research report(1). “Improving the performance of the pharmaceutical manufacturing enterprise requires an integrated approach to quality management, with an initial focus on excellence in core production processes and process controls.”
Datasweep’s successful track record in providing solutions for companies such as General Electric, Johnson & Johnson, St. Jude Medical, and Respironics demonstrates its knowledge and experience in FDA-regulated environments.
About Datasweep
Datasweep is a recognized leader in enterprise software solutions that help global manufacturers achieve predictable and profitable product supply through a quality-based approach to manufacturing operations. Datasweep solutions extend the value of ERP systems by creating and controlling continuous improvement processes while building detailed product history records based on production operations, supplier management, service and repair, quality management and regulatory compliance. Headquartered in San Jose, California, Datasweep serves customers in high-tech, medical device, pharmaceutical, automotive, telecommunications and other industries, including ArvinMeritor, General Electric (GE), Johnson & Johnson (JNJ), KLA-Tencor Corporation (KLAC), LSI Logic (LSI); Lucent (LU), Pemstar (PMTR), Qualcomm (QCOM), Siemens Medical Group USA (SI), SonoSite (SONO) and St. Jude Medical (STJ). Additional information can be found at www.datasweep.com .
Datasweep is a registered trademark and Datasweep Advantage is a trademark of Datasweep, Inc. All other trademarks are the property of their respective owners.
(1)”Pharmaceutical and Life Sciences Industry Outlook,” Roddy Martin, AMR Research, September 2004, and “Pharmaceutical Quality: Build It Into the Process,” Roddy Martin, AMR Research, May 2004
