Life Sciences - Manufacturing Quality Control Software - Because your profit is on the bottom line...

Life Sciences

Real-time Statistical Process Control & Analysis for the Life Sciences Industry


  • Prevent Product Defects
  • Improve Product Release Cycles
  • Maximize Productivity and Profitability
  • Reduce Waste
  • Meet FDA Regulatory Requirements

DataNet Quality Systems provides Life Sciences manufacturers with a real-time Statistical Process Control (SPC) solution to automate, monitor, control, and improve product and process quality, resulting in better products, faster release cycles, and increased profitability.

Through a combination of real-time SPC software, implementation and configuration services, software validation, and a variety of extended support and service programs, DataNet offers a comprehensive solution designed to support your team throughout the entire quality control program lifecycle.

  • Real-time SPC software
  • IQ, OQ, PQ Validation Services
  • Web-based Manufacturing Intelligence
  • FDA 21 CFR 11 Compliance
  • Installation and Training Services
  • Extended Service and Support


Superior support for FDA-regulated industries


Ensure compliance with 21 CFR Part 11
WinSPC supports the FDA 21 CFR Part 11 requirement for electronic signatures, making it easier for manufacturers to ensure compliance while focusing on product and process quality. WinSPC offers the following functionality designed specifically to enable you to comply with FDA 21 CFR Part 11:
  • Complete audit trail documentation
  • Lot traceability
  • Electronic signatures
  • Electronic records
  • Advanced security controls and password protection
  • Event log: Store and retrieve nearly any type of system-wide activity, such as edits to data or specification limits, failed log-ins, and more
  • All system data and application data are stored centrally in a single SQL database (passwords, configurations, audit trail documentation, etc.)


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Log, store, search, trace & audit your process quality data using WinSPC's event log
WinSPC's system event log allows you to store virtually any vital process information, such as electronic signatures, corrective actions, systems edits and more. The enhanced filtering and search functions make it easy to produce reports for company audits and comply with regulatory requirements. Of course, all the event log data is stored in a central, secure database for compliance with FDA 21 CFR Part 11.
  • Search, store, sort, report, print, archive or export logged events
  • Capture audit trail documentation
  • Enable complete traceability
  • Capture electronic signatures
  • Perform fast queries







Software Validation


Validation Toolkit DataNet’s WinSPC Software Validation services allow you to quickly and cost-effectively validate your SPC software.
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Validation Toolkits

Learn more about DataNet's Software Validation services

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Get Started

  • Download a free trial of WinSPC
  • Get a web demo of WinSPC and find out if it is right for you
  • Call 1-866-4WINSPC or email us at This email address is being protected from spam bots, you need Javascript enabled to view it
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