Solta Medical Meets FDA Compliance With Omnify Software
February 09 2009 - 8:30AM
Marketwired
Omnify Software, a leading provider of Product Lifecycle Management
(PLM) software for electronic, medical, mechanical, and defense
manufacturers, today announced that Solta Medical, Inc. (NASDAQ:
SLTM), a global leader in the medical aesthetics market and holding
company for the Thermage� and Fraxel� brands, 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."
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
info@omnifysoft.com 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
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