April 20, 2005
WinSPC® Software from DataNet Satisfies 21 CFR Part 11 Requirement
SOUTHFIELD, Mich.–April, 2005–DataNet Quality Systems now provides the most robust real-time Statistical Process Control (SPC) software available to the medical device and pharmaceutical industry. WinSPC C/S Enterprise offers manufacturers a single solution for combined automated and manual data collection operations, with a full array of SPC tools to enable compliance with the Electronic Records and Signatures requirement of FDA Title 21 CFR Part 11.
Award-winning WinSPC software has long been a trusted quality control solution chosen by leading manufacturers throughout the world. Renowned for its ease of use for administrators and operators, WinSPC C/S includes a granular security system and traceability capabilities that meet the most stringent regulatory standards. Some of the enhanced security controls and features include:
- Secure access to virtually every function and feature by login, individual user and user group
- Audit trail maintains all original product and process configurations, specifications, and collection methods; changes and edits are logged with original and changed values
- Password controls include configurable number of allowed attempts, automatic expiration, reuse prevention, form and encryption enforcement
- Configurable automatic logoff from data collection based upon inactivity
- Option to log reason for every action that requires an electronic signature
These capabilities further enhance WinSPC’s reputation as the premier SPC solution for world-class medical device and pharmaceutical manufacturers.
Additional features that distinguish WinSPC include:
- Client/Server architecture supporting deployments on Oracle, MS SQL and other major databases
- Centralized administration that minimizes configuration time
- Real-time data collection from almost any automated digital output, such as gauges, devices, keyboard, CMMs, PLCs, lab equipment, electronic testing devices and barcode readers
- Fully customizable reports that can be published via the internet
- Intelligent closed-loop feedback with configurable triggers to automatically flag and respond to user-defined violations.