Are you in the Medical Device industry? Reduce cost, time and energy on validation. Software solutions are now an integral part in the product development of a medical device. Software solutions should be validated during three stages: the initial implementation, software upgrades, and customer modifications. The Cognition Corporation’s latest case study explores the benefits of using the Validation Kit for product development teams, which include “improving efficiency and reliability of integrating requirements management programs” and “risk mitigation while performing innovative low-cost/high-quality product development initiatives.” For more information on the case study, click here.
“Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes into its larger business strategy, the benefits go far beyond compliance.”
To learn more about the benefits from project leadership, check out the case study by Integrated Project Management, click here.
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.
“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.”
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.
This PDF by Averna will delve into:
- Higher and higher frequencies
- More RF standards, fewer test resources
- Increased Takt time and slower throughput
- Capturing large instantaneous bandwidths
- Streaming large amounts of RF data
Click on the link below to check out the full PDF about the major test challenges for RF products!
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.
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.
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.
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: