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DataNet Supplies Real-Time SPC Software to Medical Device and Pharmaceutical Manufacturers


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 gages, 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.
 

About DataNet


DataNet Quality Systems delivers quality control software and services that empower manufacturers to improve product and process quality through real-time Statistical Process Control. WinSPC and QualTrend software, in combination with DataNet's solution delivery services, enable manufacturers to:
  • Identify, control and prevent defects
  • Close the quality loop from "detection to correction"
  • Gain executive-level visibility into shop floor operations

With over 2500 installed facilities worldwide and distributors throughout the world, DataNet is dedicated to delivering a high level of customer service and support, shop-floor expertise, and professional continuous improvement, Six Sigma, and Lean Manufacturing services.


© Copyright 2008, DataNet Quality Systems. All rights reserved. WinSPC and QualTrend are registered trademarks of DataNet Quality Systems. All other trademarks are the property of their respective owners.


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