Suite for Small to Medium Companies
FastTrak Med Device™ offered by Integware, is a powerful, user friendly and feature rich set of solutions that encompass key elements of 21 CFR part 820 and part 11 compliance:
- Document Management
- Change Control
- Product Development Process (PDP)
- Design History File (DHF)
- Configuration Management / Device Master Record (DMR)
Integware’s FastTrak Med Device™ solution suite is:
- Priced specifically for the small to medium-sized medical device company
- 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 Med Device™
- Accelerates new product launches
- Reduces time-to-market
- Reduces cost of compliance for 21 CFR part 820 and part 11
- Reduces cost of quality (excess/rework/scrap)
- Minimizes preparation for FDA audits
- Implements quickly - 6 weeks or less
- Returns a rapid ROI - less than 12 months
- Integrates all processes seamlessly
- Includes validation scripts, online training and documentation in its All In Delivery™
- Employs industry proven processes