August 22, 2008
Medical Device and Pharmaceutical Manufacturers Choose WinSPC Statistical Process Control Software to Assure Superior Product Quality and Regulatory Compliance
DataNet Adds New Life Sciences Manufacturers To Growing Customer List
SOUTHFIELD, Mich.-August 21, 2008-DataNet Quality Systems (DataNet), manufacturer of WinSPC® and QualTrend® Quality Control software, announced today that it has added two new Life Sciences manufacturers to its growing customer list and has had an existing customer, also a Life Sciences manufacturer, extend its deployment of WinSPC internationally. The companies, one medical device manufacturer and two pharmaceutical manufacturers, plan to rollout WinSPC across their facilities within the next 90 days.
“Based on our discussions with Life Sciences manufacturers, we see a real need for these manufacturers to access, and respond to, real-time process information. This gives them the power to prevent the process errors that lead to defects,” said Stephen A. Arnett, DataNet’s CEO. “Additionally, our solution provides tools to lower the cost of regulatory compliance and build product traceability into their processes. We are excited to be able to broaden our reach within this industry and expect growing revenue within this segment.”
The two pharmaceutical companies will deploy WinSPC across their international operations. Their goal is to assure product quality and comply with regulatory requirements. They chose WinSPC for its ease-of-use, FDA 21 CFR 11 compliance, and DataNet’s software validation support. The companies will validate WinSPC using DataNet’s Software Validation Toolkit, which offers a complete set of IQ and OQ software validation templates.
The medical device manufacturer plans to expand WinSPC to its Chinese plant, where it will automate data collection and assure superior quality through preventative SPC techniques. It has been using WinSPC at its U.S. facilities since 2005.