Are you struggling with finding a fully validated Requirements Management Tool?

In Generis, generis group, Life sciences, manufacturing, manufacturing operations, medical device, medtech, mfg, Uncategorized by Generis0 Comments

“Validation is required, as regulated by FDA, to ensure that a company’s product development software/system will meet its intended purpose. The software/system must show that it will function in a reliable, consistent manner and is in compliance with regulatory and business requirements. Additionally, once the software/system has been accepted and released for use, there is a need to maintain compliance and fitness throughout its operational life. Unfortunately, information on how to develop a validation plan and the activities expected as part of a validation effort are limited and subject to misinterpretation.” Are you struggling with finding a fully validated Requirements Management Tool? If so, check out the full white paper by Cognition!     

Sonoco ThermoSafe Expands Range of LD7 Pallet Shippers for Temperature-Sensitive Bulk Air Shipment

In additive manufacturing, commercialization, design, design engineering, Design Thinking, Generis, generis group, logistics, manufacturer, manufacturing, manufacturing operations, medical device, operational excellence, product design, product development, production efficiency by Generis0 Comments

Sonoco ThermoSafe, a unit of Sonoco (NYSE:SON) and a leading global provider of temperature assurance packaging, leverages award winning technology to expand its line of pallet solutions with the launch of the LD7 Half PAG pallet shipper. The Half PAG solution is designed to ship multiple pallet loads, while reducing the cost and operational complexity of bulk shipments by optimizing the use of aircraft ULDs (LD7 air pallets). The Half PAG is available for 2-8°C or 15-25°C temperature ranges with durations in excess of five days. Each solution has a universal pack-out design to be used in both hot and cold seasons while also accommodating the demands of cross-hemispheric shipments. To learn more about LD7 Half PAG Pallet Shippers, Check out this article by Sonoco! 

Cost-Effective Range of 48-Hour Pre-Qualified Temperature Controlled Shippers

In biotechnology, Generis, generis group, healthcare technology, Life sciences, manufacturing, manufacturing operations, medical device, pharmaceutical by Generis0 Comments

Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons. To learn more about qualified temperature controlled shippers, check out this article by Sonoco!

Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships

In biomanufacturing, healthcare technology, Life sciences, logistics, manufacturer, manufacturing, marketing, medical device, pharmaceutical, technology by Generis0 Comments

Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits: To learn more about smart outsourcing and what the operational and business benefits are, check out this white paper by OQSIE 

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Q&A eBook with QT9 Software: Benefits of Automating Your Quality Management System with Software

In emerging technology, Generis, innovation, manufacturing, medical device, medtech, quality, Quality Management System, Quality System Management, technology by Generis0 Comments

Industry regulations can make life for medical device manufacturers very challenging. Regulations are there for a reason and are required to grow and improve your business. This is different than in most manufacturing sectors. Demonstrating compliance to these various regulations requires meticulous record management. As an example; the ability to easily manage and maintain your records for Product Design, can provide an organization with a competitive edge for getting new products, or enhancing existing products for their market. QT9 Software will be speaking at our American Medical Device Summit taking place October 4-5th, 2017 in Chicago, IL. The presentation topic will be on the “Benefits of Automating Your Quality Management System with Software.” We asked Brant a few questions about quality management, issues medical device manufacturers are facing today, and how to save time and money in the industry. Please, take a look at our Q&A eBook with Brant Engelhart from QT9 Software below!

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Industry Insights: Interview with Dr. Steve Levine, Dassault Systèmes

In manufacturing, medical device, medtech, technology by Generis0 Comments

At Generis’ American Medical Device Summit 2016, we sat down with Dr. Steve Levine, Senior Director of Product Strategy and Executive Director of the Living Heart Project at Dassault Systèmes and discussed scientific innovation initiatives such as the Living Heart Project, realistic simulation, and technology’s role in the industry. Check out the full video below!

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The Future of Medical Device Manufacturing

In compliance, cost reduction, manufacturing, medical device, medtech, mfg, technology by Generis0 Comments

The medical device manufacturing world can be a competitive space, and it can be difficult to stay afloat among other competitors. In this executive brief by Copley Consulting, you will find out more about key initiatives that will allow you to maintain a strong, competitive position in this space. With next-generation ERP systems that include the newest analytics and tools for collaboration, you can meet Baby Boomer demand while controlling costs. Key highlights include: Improving agility; Fostering collaboration; Keeping up with changing demands; Lowering costs and reducing lead times; and Gaining a competitive edge. Find out more about these key themes and ERP systems in the full brief below: 

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Infor CloudSuite Industrial (SyteLine) for Medical Devices

In cost management, cost reduction, manufacturing, marketing, medical device, medtech, quality, Quality Management System, Quality System Management, risk management by Generis0 Comments

For medical device manufacturers, advancing and maintaining information management solutions that are compliant with an evolving set of FDA regulatory standards is a constant challenge. As you strive to manufacture high-quality medical devices, you need an enterprise resource planning (ERP) solution that can help you minimize compliance risk, as you maintain profitability, drive efficiencies, and streamline all parts of your business. This article will delve into: Upholding GMP quality standards; Maintaining regulatory compliance; Using integrated electronic records; and Meeting regulatory requirements. To find out more about how to reduce compliance risks and meet regulatory requirements, check out the white paper by Copley Consulting Group below: