Datasweep Releases Validation Solution for Software Compliance.Business Editors/High-Tech Writers SAN JOSE San Jose, city, United States San Jose (sănəzā`, săn hōzā`), city (1990 pop. 782,248), seat of Santa Clara co., W central Calif.; founded 1777, inc. 1850. , Calif.--(BUSINESS WIRE)--Feb. 23, 2004 Life Sciences Solution Developed in Collaboration with KMI/PAREXEL; Brings Risk-based Approach to Validating Manufacturing Processes and Systems Datasweep, Inc., a recognized leader in software solutions that help global manufacturers drive performance, quality and value across the product lifespan, today announced the availability of the Datasweep(R) Validation Solution(TM) for Life Sciences, a comprehensive solution that combines technical guidance with implementation services to accelerate and certify validation of the Datasweep Advantage(TM) suite of manufacturing software The following list of software modules are the manufacturing components of Baan's ERP (BaanERP) system, acquired by SSA Global in 2003 and subsequently by Infor at the end of 2006. It is listed here because it provides a comprehensive overview of the required software. See MES. products. Developed in collaboration with KMI/PAREXEL, a leading provider of validation solutions for bio/pharmaceutical manufacturing, the new solution brings a risk-based approach to addressing Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) requirements for validation of off-the-shelf software used during product development and in the manufacturing process. The Datasweep Validation Solution cuts product delivery time-to-market for global Life Sciences manufacturing firms. The solution's pre-defined templates and scripts provide a turn-key option to accelerating the tasks and reducing the burden of the validation process. The solution delivers out-of-the-box, proven techniques, guidelines, checklists, risk-based traceability matrices, flowcharts and plans. The solution is designed to address regulatory compliance requirements Compliance requirements are a series of directives established by United States Federal government agencies that summarize hundreds of Federal laws and regulations applicable to Federal assistance (also known as Federal aid or Federal funds). referenced in 21 CFR CFR See: Cost and Freight Part 820, 21 CFR Parts 210 and 211, 21 CFR Part 11, and ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485: 2003. "A robust validation process can help accelerate time-to-market, reduce implementation costs without compromising safety and effectiveness, and provide a sustainable business process for risk management and regulatory compliance," said Ronald Tetzlaff, Ph.D., President, KMI/PAREXEL. "We are pleased to collaborate on the definition of Datasweep's Validation Solution and look forward to providing clients with our expertise in the implementation of Datasweep Life Sciences validation solutions." "KMI/PAREXEL is a leading provider of manufacturing compliance and validation services," said Dr. Bo Preising, director, Life Sciences at Datasweep. "We specifically chose them to help define and provide validation consultation for the Datasweep Validation Solution due to their expertise and proven methodologies on the application of risk assessment to reduce the complexity and length of the validation process." About KMI/PAREXEL KMI/PAREXEL, a Division of PAREXEL International, is a peak performance management consulting company that advises leading pharmaceutical and medical device companies on technical and regulatory issues involved in the manufacture of medical products. By integrating quality expertise with tools and techniques for process improvements, organizational change, and technology innovation in manufacturing, quality assurance/control, validation and information technology, KMI/PAREXEL helps companies obtain peak performance in manufacturing, from discovery through commercial launch, which in turn can help to deliver extraordinary bottom line results. KMI/PAREXEL, headquartered in Waltham, MA, is an operating unit operating unit A type of operating company that engages in transactions with outsiders and that is owned by another business. For example, in 1995 the stockholders of Capital Cities/ABC approved a $19 billion merger with the Walt Disney Company, whereupon of PAREXEL International Corporation's PAREXEL Consulting Group. PAREXEL is one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of expertise in clinical research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Additional information can be found on the Internet at www.kminc.com. About Datasweep Datasweep is a recognized leader in software solutions that help global manufacturers drive performance, quality and value across the product lifespan. Based on operations performance management best practices, Datasweep solutions uniquely drive continuous improvement through unit lifecycle management to improve process efficiencies, increase product quality and reduce product lifecycle costs. Headquartered in San Jose, California San Jose (IPA: /ˌsænhoʊˈzeɪ/) is the third-largest city in California, and the tenth-largest in the United States. It is the county seat of Santa Clara County. , Datasweep serves customers in high-tech, life sciences, automotive, telecommunications and other industries, including Flextronics International, Ltd. (FLEX), General Electric (GE), Harris Corporation (HRS), Johnson & Johnson (JNJ JNJ Johnson and Johnson (stock symbol) JNJ Journal of Nursing Jocularity ), KLA-Tencor Corporation (KLAC), Lucent (LU), Plexus Plexus - A modular World-Wide Web server written in Perl by Tony Sanders <sanders@earth.com>. Comes with interfaces to allow many other information services to be served via the Web. Version 3.0m 1994-07-22. , (PLXS), Siemens Medical Group USA (SI), SonoSite (SONO) and St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. (STJ STJ Superior Tribunal de Justica (Brazil) STJ Supremo Tribunal de Justiça (Portugal) STJ Superconducting Tunnel Junction STJ San Giljan (postal locality, Malta) ). Additional information can be found on the Internet at www.datasweep.com. Datasweep is a registered trademark of Datasweep, Inc. Advantage and Validation Solution are trademarks of Datasweep, Inc. PAREXEL is a registered trademark of PAREXEL International Corporation. All other trademarks are the property of their respective owners. |
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