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Unlocking Success: The Transformative Benefits of Variant Management Through Product Line Engineering Embark on a journey of innovation and efficiency with this webinar on the benefits of variant management through Product Line Engineering (PLE), as we explore how PLE serves as a catalyst for organizational success. In this insightful session, our industry experts will guide […]
MIL-STD-810: Ensuring Quality and Reliability in Challenging Defense Environments From the desert to swamps to the frozen tundra, the United States Department of Defense (DoD) created the Military Standard 810 (MIL-STD-810) to enforce manufacturers deliver a product that will not fail in operational environments. This compliance regulation outlines environmental engineering considerations for testing equipment’s durability, […]
Unveiling the NASA Systems Engineering Handbook Rev2: A Comprehensive Guide for Space Exploration NASA, the National Aeronautics and Space Administration, has been at the international forefront of space exploration for decades, pushing the boundaries of human knowledge and expanding our understanding of the universe. Behind every successful NASA mission lies a robust framework of engineering […]
Streamlining Defense Contract Bid Document Deliverables with Jama Connect® In the defense sector, whether it is a large prime, a subcontractor, or one of the thousands of other organizations under the defense umbrella, winning a contract bid for the United States Government comes with as astronomical amount of document deliverables that can be daunting and […]
Digital Engineering Between Government and Contractors How does a digital thread work when tool ecosystems are disconnected from each other? For the defense contracting world, THIS is the elephant in the room. The DoD (Department of Defense) wants its Digital Engineering (DE) vision to become a reality and they do realize it cannot happen overnight, […]
A comprehensive look at ISO/IEC/IEEE 15288 goals, standards, and tools to achieve compliance. Product development is evolving quickly; over the past few years, it’s become increasingly complex. A study of nearly 300 design and engineering professionals found that 92% of respondents say they’re experiencing at least one form of increased complexity. Moreover, 76% say they’re […]
In this blog, we define GAMP®5, the framework for a risk-based approach, with an introduction and conclusion provided by Jakob Khazanovich, Medical Device Solutions Consultant at Jama Software®. This blog contains details sourced from the International Society for Pharmaceutical Engineering. What is GAMP®5 and How Does Its Guidance Help Regulated Companies Using Computerized Systems? When […]
DOD 5000 Series DOD 5000 Series consists of policy guidance and is backed by a collection of directives that describe a disciplined management approach for acquiring systems and materiel to satisfy valid military needs. Six pathways of the adaptive acquisition framework: urgent capability acquisition; middle tier of acquisition (MTA); major capability acquisition; software acquisition; defense […]
Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA Intro Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative […]
Editor’s Note: This blog was originally published through IEEE Innovation at Work, “Managing Complexity in Systems Engineering for Product Development with Live Traceability,” by author Nikhil Rai, IEEE Senior Member, Senior Director of Product and Solutions Marketing at Jama Software. Systems Engineering for Product Development with Live Traceability Complexity of Product Development is Exploding In […]