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ISO 24089, developed by the International Organization for Standardization (ISO), is a standard that provides guidelines for managing software updates in a methodical and orderly way. Planning, testing, deployment, and monitoring are all included in the framework for managing the software update process that is specified by the standard. The main requirements and advantages of […]
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 […]
The Top Challenges in Industrial Manufacturing and Consumer Electronic Development From supply chain disruptions to digitization – learn more about what development teams are up against and get expert suggestions for how to overcome them PART I: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development Industrial manufacturing has always been a cornerstone of […]
Your Guide to the Verifying Accurate Leading-edge IVCT Development (VALID) Act For more than four years, members of both houses of Congress have solicited input from a variety of stakeholders to improve Food and Drug Administration (FDA) oversight of Laboratory-Developed Tests (LDTs). The result is the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bi-partisan and […]
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 […]
Jama Software® is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Regulatory Focus – Euro Roundup: MDCG publishes guidance on MDR, IVDR authorized representative requirements – originally published […]
When personal computers first came into common use in the 1980s, the closest a microchip came to an automobile was during transit to its final destination. Few consumers could have predicted there would come a time when their automobiles would be controlled by computer chips, much less have integrated technologies to manage everything from cell […]
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 […]
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Hali-Brite® – What Is a Vertiport: Everything You Need to Know – originally published on […]
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 […]