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!     

Case Study: 4 Steps to solving Complex Development Projects

In Generis, generis group, healthcare technology, manufacturing, manufacturing operations by Generis0 Comments

Successful companies are constantly fine-tuning existing products and planning new ones. But even the most ambitious businesses can suffer when critical projects get backed up in the pipeline. Management at Chicago-based Rauland-Borg Corporation realized its good intentions were being subverted by the lack of effective project portfolio management (PPM), and decided to do something about it.   Check out the full case study to discover the four step approach to solving complex development projects. 

Does Data Help or Hamper Your Ability to Execute Effectively?

In additive manufacturing, automotive, commercialization, Generis, generis group, logistics, manufacturing, supply chain by Generis0 Comments

Winning the game requires you to manage the details in short increment time intervals. For a fast/short cycle time business, if you learned that you missed the day at the end of the day, it’s too late to do much about it. But if you had the ability to measure and address performance in hourly or shorter time frames, there’s time to take action to ensure you meet the day’s goals. To learn more about data-driven daily management, check out this eguide by Dploy Solutions! 

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!

Are You Forgetting Something In Your Single-Use Strategy?

In biomanufacturing, biotechnology, Generis, generis group, innovation, manufacturer, manufacturing, manufacturing operations, system design by Generis0 Comments

In your experience, what has the outcome been like when an organization has taken the time to improve its’ single-use strategy? The first thing people sigh in relief about is that there is no danger of breathing in particles and that they are dispersing all over the manufacturing facility. Once the system is closed, there is no longer so much time spent on cleaning and validation. In addition, it helps speed up the process making it so there is one less bottleneck on the road to continuous manufacturing. To learn more about single-use strategy and make sure you are including everything you need, check out the full ebook by ILC Dover below! 

Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In biomanufacturing, business, Generis, generis group, manufacturing, pharmaceutical, production efficiency by Generis0 Comments

In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below! 

CRYSTALOMICS: A PATHWAY FORWARD FOR PROTEIN CRYSTALLIZATION

In biomanufacturing, Generis, generis group, healthcare technology, Life sciences, logistics, manufacturing by Generis0 Comments

Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development. All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home. This informative white paper by Althea covers the challenges of crystallization of proteins for therapeutic use and how to preserve efficiency during crystallization. Learn more about a pathway forward for protein crystallization in the white paper below!   

Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most

In biomanufacturing, Generis, generis group, healthcare technology, innovation, Life sciences, logistics, manufacturing, mfg, pharmaceutical, production efficiency, supply chain, technology, testing by Generis0 Comments

World Courier is transporting Zika diagnostic test kits to and from South America. Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind. The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending. Take a look at the full white paper below!