February 7, 2001
New SPC Features Support FDA Electronic Signature Requirements for Food, Beverage and Life Science Manufacturers
SOUTHFIELD, Mich.–Feb. 7, 2001— DataNet Quality Systems, a real-time SPC software manufacturer, announced today that it will introduce Version 1.4 of its award-winning statistical process control software at Booth # 6357, National Manufacturing Week , March 5- 8, McCormick Place, Chicago, IL. WinSPC v1.4 includes new password controls that allow users to fully satisfy the FDA’s Electronic Signatures requirement as specified in 21 CFR part 11.
Enhanced password administration capabilities allow users to set password controls that verify user access to software modules and forms, and confirm rights to open or utilize elements of Data Collection and Administration. Password changes are enforced and tracked to avoid duplication, assure scheduled password changes and to verify compliance to regulatory requirements.
Expanded OLE Automation properties
WinSPC’s OLE Automation capabilities have been greatly enhanced in v1.4. Improvements include expanded automated control of data collection, making virtually all aspects of data collection accessible through OLE Automation. With this added flexibility, users can now utilize a custom GUI to match data collection scenarios or machine interfaces already in place and automatically have SPC monitoring and alarming in the background.
Web-based reporting
The new release features advances in WinSPC’s Custom Web Reporter (CWR), a Web-based solution that provides fully customizable report generation with extensive statistical analysis and graphing tools. The CWR uses the web or corporate intranet to provide worldwide distribution of quality and related production-level information to enterprise management, customers and suppliers. Version 1.4 provides additional reporting templates and methods to analyze and report on Key Performance Indicators for manufacturers.
“With CWR, users can create reports customized for the recipient, delivered anywhere in the world via common Web browsers,” said Ned Greenberg, DataNet Vice President. “With the power to analyze data and present reports and charts over the Web, this technology can provide enterprise-wide management reports in minutes rather than the weeks it used to take.”