Superior support for FDA-regulated industries

Superior support for FDA-regulated industries

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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

 
Visit us at Booth #727 for a demonstration of our latest WinSPC release.
 
Successes
"It's been a great process improvement tool for us. Since implementing WinSPC we've been able to stabilize our process, increase throughput, and reduce scrap"

Doug McKinley, Quality Manager
Paragon Medical

Other successes include
Abbott Laboratories
Advance Turning & Manufacturing, Inc.
Allergan
APEX International
Astellas Pharma Inc.
Beckman Coulter
Becton Dickinson
Bristol-Myers
Carelton Life Support
Centerpulse
Cholestech
Conor Medsystems Inc.
Edwards Lifesciences
GAMBRO
Genpharm, Inc.
Guidant
Instrumentation Laboratory
Invitrogen
Johnson & Johnson
Lake Region manufacturing
Medtronic
Millipore Corporation
OSG Pharmaceuticals
Paragon Medical
Pall
Porex
Pulmonetic Systems, Inc.
QuadraSpec, Inc.
Schering-Plough
Superior Tube
Terumo Medical Corporation
Tyco