A global medical device company founded in 1856, Smith & Nephew employs 10,000 people in 36 countries. Smith & Nephew markets innovative and clinically superior products, principally in orthopedics, endoscopy, wound management, and rehabilitation, that offer clear clinical and cost benefits, plus industry-leading service.
Smith & Nephew’s orthopedic unit began searching for a product lifecycle management and collaboration tool in 1999 to replace its non-millennial compliant PDM system. As a medical device company operating in the United States, Smith & Nephew is also bound by FDA regulations. Any new system must comply with those regulations, especially 21 CFR Part 11 (commonly referred to as Part 11), that pertain to electronic records and electronic signatures.
Dassault Systèmes Response
In addition to meeting Smith & Nephew’s needs for a millenniumcompliant product lifecycle management tool, eMatrix’s high degree of flexibility ensured Smith & Nephew could configure the system to comply with the FDA’s Part 11 regulations. The Smith & Nephew implementation team, which was certified in CMII for configuration management, ensured eMatrix™ met the organization’s exacting needs for global configuration management.
• Increased Productivity Designs adjusted in real-time online • Dramatically Improved Global Collaboration Version control issues eliminated by eliminating global paper trail • FDA Part 11 Regulatory Compliance Flexibility and configurability of eMatrix enabled system to be modified for compliance