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!     

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 

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!

View Post

Optimizing Temperature Control for Biopharmaceuticals

In biomanufacturing, biotechnology, Generis, industrial markets, innovation, Life sciences, logistics, manufacturer, manufacturing, mfg, pharmaceutical, quality, Quality by design, risk management, safety, supply chain, system design, technology by Generis0 Comments

This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

View Post

How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency

In emerging technology, Generis, healthcare technology, innovation, Lean manufacturing, Life sciences, manufacturing, medical device, medtech, mfg, product development, production efficiency, Quality by design, risk management by Generis0 Comments

Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain. This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps. Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:

eBook: Realistic Simulation for Medical Device Developers

In design engineering, Design Thinking, innovation, Life sciences, manufacturing, medical device, medtech by Generis0 Comments

Medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reducing development costs, and improving patient safety and product quality. In addition, SIMULIA provides medical device companies with the ability to more efficiently evaluate design alternatives, accelerate long-term stress life testing to predict product reliability, collaborate on projects and leverage computing resources for more efficient design analysis. Check out the eBook below!  

eBook: Product Content Management in a Regulated Environment

In compliance, Life sciences, medical device by Generis0 Comments

In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above. In the eBook below, Seismic addresses some of the challenges that life sciences companies face and provides some solutions to these challenges. Check out the eBook below!    

What Happens When Life Sciences Messaging Doesn’t Meet FDA Regulations

In commercialization, Life sciences, medical device by Generis0 Comments

Medical device organizations face a number of regulatory and compliance challenges ranging from design and development to commercialization.  In preparation for the American Medical Device Summit 2016 we wanted to share the post below to introduce some of the challenges that can arise when life sciences messaging doesn’t meet FDA standards. The Seismic blog post below discusses some common missteps life sciences marketers make when it comes to FDA compliant messaging, and the consequences to distributing non-compliant medical product promotional content. It also offers some simple solutions for avoiding those missteps. Check out the post!