Critical decision: Omnify sees PLM uptake in highly regulated med device industry

02/02/2009


Omnify Software reports an increase in medical device manufacturers implementing product life-cycle management (PLM) technology due to the ability of Omnify’s solutions 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 , a designer and manufacturer of patient monitoring technology; Pacific Biosciences , a developer of third-generation DNA sequencing technology; PLC Medical Systems , 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 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,” says Chuck Cimalore, Omnify CTO. “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 to meet stringent FDA compliance guidelines.”
“PLC’s validation of Omnify Empower confirmed that we chose wisely in selecting a PLM product,” says 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.”





No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2013 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Leaders Under 40 program features outstanding young people who are making a difference in manufacturing. View the 2013 Leaders here.
The new control room: It's got all the bells and whistles - and alarms, too; Remote maintenance; Specifying VFDs
2014 forecast issue: To serve and to manufacture - Veterans will bring skill and discipline to the plant floor if we can find a way to get them there.
2013 Top Plant: Lincoln Electric Company, Cleveland, Ohio
Case Study Database

Case Study Database

Get more exposure for your case study by uploading it to the Plant Engineering case study database, where end-users can identify relevant solutions and explore what the experts are doing to effectively implement a variety of technology and productivity related projects.

These case studies provide examples of how knowledgeable solution providers have used technology, processes and people to create effective and successful implementations in real-world situations. Case studies can be completed by filling out a simple online form where you can outline the project title, abstract, and full story in 1500 words or less; upload photos, videos and a logo.

Click here to visit the Case Study Database and upload your case study.

Bring focus to PLC programming: 5 things to avoid in putting your system together; Managing the DCS upgrade; PLM upgrade: a step-by-step approach
Balancing the bagging triangle; PID tuning improves process efficiency; Standardizing control room HMIs
Commissioning electrical systems in mission critical facilities; Anticipating the Smart Grid; Mitigating arc flash hazards in medium-voltage switchgear; Comparing generator sizing software

Annual Salary Survey

Participate in the 2013 Salary Survey

In a year when manufacturing continued to lead the economic rebound, it makes sense that plant manager bonuses rebounded. Plant Engineering’s annual Salary Survey shows both wages and bonuses rose in 2012 after a retreat the year before.

Average salary across all job titles for plant floor management rose 3.5% to $95,446, and bonus compensation jumped to $15,162, a 4.2% increase from the 2010 level and double the 2011 total, which showed a sharp drop in bonus.

2012 Salary Survey Analysis

2012 Salary Survey Results

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.