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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 empowers manufacturers to improve products, processes, and profitability through real-time statistical software solutions.  The company’s vision is to deliver trusted and capable technology solutions that allow manufacturers to create the highest quality product for the lowest possible cost. DataNet’s flagship product, WinSPC, provides statistical decision-making at the point of production and delivers real-time, actionable information to where it is needed most. With over 2500 installed facilities worldwide and distributors across the globe, 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 2009, 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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