CIMdata PLM Industry Summary Online Archive
12 January 2009
Product News
Omnify Software Delivers Features to Help Customers in a Highly Regulated Industry
Omnify Software 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."
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