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