Life Sciences Industry Manufacturers Choose WinSPC Real-time SPC Software to Lower Costs While Meeting Regulatory and Customer Requirements
Life Sciences industry manufacturers Beckmann-Coulter, GenPharm, and Patheon selected DataNet to provide the real-time SPC solution for their manufacturing operations. Citing the need to reduce manufacturing costs and satisfy exacting regulatory requirements, these companies chose WinSPC because of its ease-of-use on the shop floor, its ability to interface with medical test devices and manufacturing systems, and its capabilities supporting audit trails, product traceability and FDA 21 CFR 11 compliance.
“WinSPC offers Pharmaceutical, Bio-tech, and Medical Device manufacturers a compelling value proposition,” said Ned Greenberg, president of DataNet. “It provides the tools to control process quality in real time to reduce costs, while at the same time offering innovative technology to meet the most stringent regulatory and customer requirements. That, in combination with DataNet’s implementation and software validation services, has enabled our customers achieve a return on their investment in as little as three months.”
Real-time WinSPC enables manufacturers to automate data collection, monitor and control process quality in real-time, perform advanced statistical analysis, and create a variety of pre-defined or custom quality reports. Additionally, WinSPC provides specific features to support the unique requirements of FDA-regulated industries, such as:
- Complete audit trail documentation
- Lot traceability
- Electronic signatures
- Electronic records
- Advanced security controls and password protection
- System-wide event log
DataNet’s Solution Delivery services offer consulting, installation, configuration, custom programming, training, and software validation services specifically designed to assist Life Sciences manufacturers in quickly and cost-effectively implementing WinSPC and QualTrend software.