Validation: 8 things you need to know

Validation of manufacturing processes is extremely important, given our highly regulated environment. Here’s a primer to get you started on the subject. Steve VanderKooi, Kyle Kulwicki, Kevin Roberts, PTI Engineered Plastics Validation uses objective evidence to prove that a process is capable of consistently producing a product that meets pre-defined requirements, including customer and user needs, functional

11 companies with interesting technology at MD&M East

Thousands of engineers and executives are expected to descend on the Javits Center in New York next week for MD&M East, the largest medical device manufacturing event on the East Coast. Fun attractions include Apple co-founder Steve “Woz” Wozniak delivering a keynote speech, the 19th annual Medical Design Excellence Awards, robot battles and a 3D printed

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What is validation and why is it perceived as so complex?

Oscar Ford/Business Development Manager/Preh IMA Automation Evansville Inc. Many perceive validation as complex, ill-defined, and fear-inducing. The question is, “Why?” Why does the mere mention of the word “validation” stimulate fear and anxiety for some people? The following might provide some insight into this perception:  In many cases validation is not consistently described and understood because

What does the FDA say about validating software?

Kevin Ballard/Director of Software Validation/MasterControl Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21

Speeding up software validation

The process of software validation is fraught with long lead times, redundancy and expense. The tools most commonly used are good ones, but by making better use of technology they could be improved – at least according to Kevin Ballard, director of software validation at MasterControl. But let’s back up a bit. To start, software regulation

NN, Inc. Precision Engineered Products Group announces validation of equipment and material properties for additive manufacturing processes

NN, Inc. Precision Engineered Products Group (PEP), a global manufacturer of highly engineered precision customized solutions serving the medical market, announced it has completed the validation and production readiness qualification of its direct-metal laser sintering (DMLS) process technology. In keeping with its strategy of innovation and providing engineered solutions, NN, Inc. PEP has secured the

MasterControl launches industry’s first transfer performance qualification solution

MasterControl has again set an industry benchmark by being the first company to deliver a Transfer Performance Qualification (TPQ) solution, which automates a previously cumbersome portion of the software validation process—a requirement for highly regulated companies. Software validation establishes documented evidence that demonstrates an organization has a high degree of assurance that the software it

NN, Inc. Precision Engineered Products Group announces validation of additive manufacturing machines and more

NN, Inc. Precision Engineered Products Group (PEP), a global manufacturer of highly engineered precision customized solutions serving the medical market, today announced that both its EOS M280 and EOS 290 additive manufacturing machines have successfully completed validation based on installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) standards.  The company performs industry-leading additive manufacturing (ASTM

ValGenesis Ventures its Validation Lifecycle Management System into the Blood Industry and Collaborates with a Leading Plasma-based Product Company

ValGenesis opened a new avenue of opportunity with a leading Plasma based product company that has implemented the paperless Validation Lifecycle Management System (VLMS) into their plasma donor collection centers. The Blood Services industry must ensure compliance with several agencies including the Food & Drug Administration, (FDA), the Center for Biologics Evaluation and Research (CBER),

What is validation & testing?

Validation & testing is the process of making sure a medical device meets all of the engineering requirements that make up its product requirements. Developers must also track all the data generated from bench-top, in-tissue, animal and human testing. All medical devices, from simple Class I products to complex Class III devices, must be tested

Evana Automation launches new validation program to assist with meeting FDA regulations 

Evana Automation Specialists, a leading Systems Integrator and builder of custom, automated assembly and test systems, recently launched a new validation program to assist healthcare product manufacturers with meeting FDA regulations during the process of implementing automated manufacturing equipment. The Evana Validation Process (EVP) was designed to help healthcare product manufacturers avoid costly mistakes – such

Medtech start ups: Finding market value and raising funds

Sean Macleod is an expert on the formation and market validation of medical therapeutic companies. He says the classic challenge for companies is taking the creative idea, science or technology, and turning it into a true market need. “The starting point of innovation really has to do with understanding the difference between solving a problem

Validating sterilization processes by ethylene oxide

Paul Dvorak | Founding Editor | Medical Design & Outsourcing The FDA’s expectation is that validating a sterilization process follows the traditional validation and verification model, commonly referred to as “V&V.” An installation qualification verifies that the sterilization equipment has been installed to manufacturer’s specification, while the operational qualification verifies that the machinery is working as intended.

Infor and The Copley Consulting Group introduce medical device industry micro-vertical solution

Infor, a provider of beautiful business applications specialized by industry and built for the cloud, and The Copley Consulting Group, one of Infor’s Gold Level Channel Partners, recently announced a new micro-vertical program specialized for the medical device industry. At the core of Infor Industrial Manufacturing for Medical Devices is Infor CloudSuite Industrial, which provides

Software validation simplified in 6 easy steps

by Kevin Ballard, Director of Software Validation, MasterControl Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software. If your company is regulated by the Food and Drug Administration (FDA), you are required to