The Thermage product is a Class II medical device and therefore is required to meet stringent FDA guidelines. Implementing Omnify and transitioning to electronic processes meant Solta Medical had to comply with 21 CFR Part 11 requirements and validate the software. "Omnify provides a controlled environment to manage all of our product data and design processes as well as the capabilities to support our FDA compliance requirements," stated Andy Kuver, Sr. document control specialist for Solta Medical. "Complete history tracking on all changes helps us to comply with electronic audit trails, and robust security features guarantee we have valid electronic signatures."
Mark Blakely, Sr. software quality assurance engineer for Solta Medical, added, "Solta Medical does not take shortcuts so we were very diligent with our validation. Because Omnify is a reliable and straightforward solution, we were able to show how we use the system and prove that it does what it is supposed to do to complete our validation fairly quickly."
About Omnify Software
Omnify Software, the leading provider of business-ready Product Lifecycle Management (PLM) solutions, helps OEMs shorten development cycles, accelerate product innovation and improve bottom-line profitability. Omnify's commitment to customer success has resulted in a unique solution that is quick to implement, easy to use, and provides an open integration platform built on the Microsoft .NET Framework. Omnify is well-known for superior customer service, delivering outstanding training, development and support with a team of experienced technology professionals. Omnify is acknowledged as an industry leader, winning such honors as START-IT Magazine's Hottest Companies for three consecutive years, START-IT 125 for two consecutive years, Power of Partnerships and Top 50 Technologies awards, as well as Manufacturing Business Technology's Top 40 Emerging Vendors and Kinetic Information's Process Innovation Award. For additional product information, including pricing, please call 978-988-3800, email Email Contact or visit www.omnifysoft.com.
"Omnify" is a registered trademark of Omnify Software. Any trade, product or service name referenced in this document using the name "Omnify" is a trademark and/or property of Omnify Software. All other trade, product, or service names referenced in this release may be trademarks or registered trademarks of their respective holders.
Media Contact: Alaine Portnoy Omnify Software Email Contact 978-988-3800 Valerie Harding Ripple Effect Communications Email Contact 617-536-8887