Sanmina-SCI Connex(TM) Validated to Comply With U.S. FDA Quality System Regulation
Jan 20, 2005
Sanmina-SCI Corporation (Nasdaq: SANM) announced Sanmina-SCI Connex(TM), a real-time business collaboration portal, has been validated to comply with the U.S. Food and Drug Administration (FDA) Title 21 Code of Federal Regulations, Electronics Records and Signatures (21 CFR Part 11).
The FDA regulation requires companies using computerized technologies and systems to have a quality system validated for the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices intended for commercial distribution in the United States.
"Sanmina-SCI Connex meets the needs of our global customers in all sectors of technology, including the medical instrumentation industry," said Dan Marinsik, Vice President of Quality Assurance and Regulatory Affairs for Sanmina-SCI Worldwide Medical Division. "Electronic products are the lifeblood of our customers, and its imperative that we meet their cost, time-to-market and regulatory requirements. Secure portal capabilities ensure we provide collaborative tools across the entire supply chain. Sanmina-SCI Connex is just one more example of our commitment to providing medical OEMs manufacturing excellence, quality and regulatory compliance."
Sanmina-SCI Connex is engineered to provide many powerful features for real-time business collaboration over the web. Sanmina-SCI business customers, partners and suppliers can easily view documentation and conduct on-line discussions specifically tailored to their business and product segment through a secure portal.