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FastTrak™ CAPA
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Integware’s FastTrak™ CAPA helps your organization manage quality issues using a proven, well-defined CAPA process. FastTrakTM CAPA is the only solution that:

  • Delivers the CAPA process required for FDA regulated companies
  • Mandates entry of comprehensive risk assessment information to accurately determine event severity
  • Identifies all potential root causes to ensure thorough investigation
  • Targets root causes with an appropriate action plan
  • Measures CAPA effectivity using a flexible monitoring plan
  • Enforces discipline with a two-stage approval process
Integware’s FastTrak™ CAPA is:
  • Designed to meet the needs of FDA regulated companies
  • Built on top of the proven, scalable, Matrix PLM Platform™
  • Delivered as a complete set of configuration services, validation scripts, online training and documentation
Benefits of FastTrak CAPA
  • Enables an accurate, concise and comprehensive FDA compliant CAPA process for 21 CFR part 820.100
  • Increases efficacy of the CAPA process
  • Supplies strong justification for business decisions
  • Moves your organizational focus from reactive to preventive
  • Minimizes adverse events and legal liabilities surrounding products and processes
  • Significantly reduces preparation for FDA audits
  • Provides direct integration with Change Control, NCR and other processes