Omnify's growing medical device customer base includes companies such as Criticare Systems, Inc., a designer and manufacturer of patient monitoring technology; Pacific Biosciences, a developer of third-generation DNA sequencing technology; PLC Medical Systems, Inc., a medical technology company specializing in innovative technologies for the cardiac and vascular markets; Still River Systems, a developer of proton beam radiation therapy (PBRT) systems; and Thermage, a leader in non-invasive tissue tightening.
Many of Omnify's medical device customers are leveraging Omnify Empower PLM to meet requirements set forth by the FDA regulation Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) and the FDA 21 CFR Part 820 Quality System regulation and have completed the Software Validation process mandated by the FDA for software used to design, develop, or manufacture medical devices.
"The benefits medical device customers receive from our PLM solution is twofold," stated Chuck Cimalore, CTO for Omnify Software. "First, they are able to benefit from improved product design and development processes; second, they are able to leverage features such as history tracking, secure electronic signatures, reporting, a closed-loop Corrective and Preventive Action system, and training records management in order to meet stringent FDA compliance guidelines."
"PLC's validation of Omnify Empower confirmed that we chose wisely in selecting a PLM product," stated Ern Damon, document control manager for PLC Medical Systems. "Quality, Purchasing and Manufacturing have easily adopted the FDA 21 CFR Part 11 compliant electronic signature process and are capitalizing on both the workflow driven change process and the speedy distribution of approved changes." Damon also noted, "Our development team is taking great advantage of the online Device Master Records and searchable Design History Files and the Training Management module provides improved communication and record keeping features at a significant labor saving over the paper process it replaced. We look forward to adding the Quality module for our CAPA process next."
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.
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Media Contact: Alaine Portnoy Omnify Software Email Contact 978-988-3800 Valerie Harding Ripple Effect Communications Email Contact 617-536-8887