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!     

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!

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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!  

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Word Press: Five Considerations When Justifying an Investment in ERP

In automation, Gemba, manufacturer, manufacturing, marketing, mfg, technology, workforce by Generis0 Comments

Organizations entering into an ERP project begin their journey by making a business case for ERP. The effort involves determining an expected return on investment, anticipating total costs and fully documenting the business case for investing in a new or upgraded system. This can’t-miss paper makes the case that it is critical to document the business reasons for an investment in ERP. You’ll see the reasons to calculate the expected value to offset the cost. Identifying risk is part of the process, as is putting in plans to mitigate risk. This white paper by Ultra Consultants will identify five considerations to keep in mind when justifying an investment in ERP leveraging Ultra Consultants’ experience in helping manufacturers with this process. View the full white paper below!

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Novel Single-Use Systems Allow Faster Powder Transfer and Higher Recovery Rates

In biomanufacturing, biotechnology, design, Generis, manufacturing, mfg, quality by Generis0 Comments

Single use powder containment practices are still in their infancy but keeping your product from cross contamination and reducing airborne particulates is important. Understanding how more modern bag designs can increase safety and speed is a concern to the industry. We looked at the ease of fill along with dispensing times and product loss. ILC Dover’s EZ-Biopac shows a 71% decrease in filling times when measured against an industry standard 2D bag. Due to the non-static film we saw an almost 20% reduction in powder discharge times. In addition, it demonstrates a 33.3% improvement in powder recovery showing reduced waste. Choosing the proper containment system can have a significant impact on plant productivity and profitability. This case study by ILC Dover will delve into: the issues of powder handling; the keys to efficient powder transfer and containment; evaluating potential systems; results; and discharge trials. Find out more about ILC Dover’s EZ-Biopac below!

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QReview: Supply Chain News You Can Use

In cost management, cost reduction, culture, facility, innovation, manufacturer, manufacturing, manufacturing operations, mfg, quality, value chain by Generis0 Comments

Transportation Impact, a 4-time Inc. 5000 company, comes from humble beginnings. In 2008, Keith Byrd and Travis Burt, both then senior-level managers at UPS, left the world’s largest shipping company after nearly two decades, respectively, to launch their own start-up with the mission of providing clients with the most competitive small package contracts in the country. The QReview is a magazine that highlights Transportation Impact’s Quarterly Review learnings and is filled with supply chain news that delves into specific strategies, statistics, and stories relevant to the supply chain industry. Take a look inside and find out how to overcome market challenges, look for optimization opportunities, and more below! Subscribe to QReview here. 

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Infographic: 8 Types of Meeting Personalities

In business, corporate culture, cost reduction, Generis, innovation, manufacturing, mfg, workforce by Generis0 Comments

Meeting Misery: Meeting Makeover Edition  This year in Corporate America–that’s your company and mine–we are going waste over $37 Billion attending meetings. It is well documented that meetings are a source of pain and great frustration due to high levels of inefficiency and ineffectiveness. Over the last 25 years, we have identified the eight most common meeting personalities that create this Meeting Misery! Find out more about the 8 types of meeting personalities below. Competitive Solutions, Inc. has a three step Meeting Makeover Solution to be applied to a single team, a specific department, or an entire organization. Find out how to get these 8 personalities out of your meetings, and end your meeting misery today! Shane Yount, Principal & Author at Competitive Solutions, will also be speaking on Business Bootcamp – Driving Greater Execution, Engagement, And Ultimately, Earnings! at our Amerian Manufacturing Summit taking place March 28-29th in Chicago, IL. View the full infographic below!

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Making Sense of IIoT Analytics

In Internet of Things, IoT, manufacturer, manufacturing, mfg, technology by Generis0 Comments

Making Sense of IIoT Analytics | Automation World As the Industrial Internet of Things (IIoT) picks up steam, attention is pivoting from connectivity to analytics, flooding manufacturers with a wave of new offerings that all promise to facilitate real business change. In the article below, find out how Sight Machine is integrating and visualizing data throughout the manufacturing industry. Sight Machine’s CEO and co-founder, Jon Sobel, explains that the company has created an automated intake process that refines data from incompatible factory floor systems and contextualizes it for subsequent analytics. Read the full article below to find out more!    

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A Change Management Strategy For Your ERP Project

In business, Generis, innovation, Internet of Things, IoT, manufacturer, manufacturing, marketing, mfg, technology by Generis0 Comments

C>R | C=a*b*d. What does this equation mean? Why is it critical to an ERP change management strategy? Successful ERP transformation projects must take many facets into consideration, in particular, people, processes and technology. Most projects address the process and technology portions, but have little or no focus on the people portion. For a transformation to be successful, it is the people component that is the most critical piece in order for the transformation to be successful. Download the full white paper below to discover the practical ways to apply current change management strategy models to prepare your business for an ERP transition. If you didn’t know the equation above, you’ll also find out the answer within! Read more below…