The Quality Management solution enabled us to organize ourselves and manage the ISO and FDA certification processes. It would have been impossible to achieve without the software. We may have gone out of business without it.
A Stronger Supply Chain
A Unified System of Record
Mitigate Risk & Ensure FDA Compliance
Upgrade your performance.
The medical device industry is growing and changing and your business has to keep up. Let Synergy help you optimize your business processes and systems, so you can expand capabilities and improve business performance.
Remain highly competitive.
Although change is hard, in today’s digital transformation era it is essential for your company to “keep-up”. Synergy’s Continuous Improvement and Change Management teams will help you sustain your competitive position. Our solutions include:
- Secure electronic signature and document control to comply with 21 CFR Part 11
- Installation Qualification (IQ), Operations Qualification (OQ), and Performance Qualification (PQ)
- Warranty and service tracking
- CAD Library Management and Bi-Directional Integration from (CAD & ERP)
- ISO 13485, ISO 9001, FDA Compliance 21 CFR Part 820
- Comprehensive Corrective Action/Preventive Action (CAPA), and Process/Product PQ functionality
- Product lifecycle management
- Nonconforming product review and tracking
- Paperless ShopFloor