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Managing Complex Pharma Projects

In corporate culture, operational excellence, pharmaceutical by Generis0 Comments

As the pharmaceutical landscape is evolving to adjust to external effects, the demand for efficiency within the internal pharma industry is at a high. Praxis Life Sciences, who is reputable for analyzing challenges within an industry workforce and creating solutions based on quantitative and qualitative research has just released a new beneficial case study to the pharma industry. Their consultation within the life sciences field has a track record of proven results, and their most recent study, Managing Complex Pharma Projects, is no exception to this. The challenge that most pharma companies are currently facing is the inefficiency created by having a large project team with “disparate decision makers.” Praxis Life Sciences has analyzed this problem, and created solutions ensuring that ” decisions and progress are made in a timely fashion.”

To learn more about the results of their case study, click here.

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. 

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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! 

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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! 

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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!

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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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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! 

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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! 

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