Omnify Software Delivers Features to Help Customers in a Highly Regulated Industry

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Mon Jan 12, 2009 10:31am EST

  ANDOVER, MA, Jan 12 (MARKET WIRE) -- 
Omnify Software, a leading provider of Product Lifecycle Management (PLM)
software for electronic, medical, mechanical, and defense manufacturers,
today announced that they have seen an increase in the number of medical
device manufacturers implementing their PLM technology due to the
systems' ability to support controlled design processes and manage data
for FDA (Food and Drug Administration) compliance.

    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
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

Copyright 2009, Market Wire, All rights reserved.

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