CIMdata PLM Industry Summary Online Archive
9 February 2009
Implementation Investments
Solta Medical Meets FDA Compliance With Omnify Software
Omnify Software announced that Solta Medical, Inc. has completed their Software Validation of the Omnify Empower PLM system. The validation supports the meeting of FDA (Food and Drug Administration) Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) compliance requirements for electronic product data management for the Thermage solution.
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."
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