March 25, 2024
The HIMSS 2024 conference on 'Creating Tomorrow’s Health' that took place in Orlando, FL, with its vibrant discussions and insights, served as a roadmap for navigating the future of healthcare. This article by Dr. Sriram Rajagopalan, Inflectra’s Global Lead on Training and Agile Transformation, synthesizes the conference's key takeaways, emphasizing the paramount importance of quality, the ethical considerations in deploying technology, and the spirit of innovation that drives healthcare forward.
Read MoreMarch 21, 2024
At the heart of a revolution, where innovation unfolds in tandem with the essence of care, the HIMSS 2024 conference in Orlando, FL, USA unfolded a narrative that could well define the future of healthcare. As reported by Dr. Sriram Rajagopalan, Global Lead on Training and Agile Transformation at Inflectra, HIMSS painted a future where AI and human compassion are not at odds but in harmony with each other and called for the re-envisioning of healthcare where every technological stride enhances the human touch, ensuring that at the very core of healthcare innovation lies the unwavering commitment to care.
Read MoreMarch 20, 2024
Dr. Sriram Rajagopalan, the Global Lead on Training and Agile Transformation at Inflectra, walks us through the seismic technological shifts transforming healthcare - straight from the HIMSS 2024 conference. This article offers insights into navigating the cutting-edge advancements poised to redefine healthcare as we know it.
Read MoreMarch 18, 2024
Since SpiraPlan is considered a validated platform to plan, develop, manage and test solutions for the life sciences industry, we are required to undergo an annual external audit of our quality and security systems. This audit has to comply with 21 CFR Part 11 as well as the ISO:9001 and ISO:27001 standards. Normally a desk audit of a software provider like Inflectra would take about 5 hours. However because we use SpiraPlan ourselves, it only took 90 minutes, and even better, it ended with no observations or issues!
Read MoreMay 17, 2018
Thanks to those who attended our recent webinar discussing the challenges and opportunities testing and validating software and systems in the life sciences and healthcare industries. We have published a recording of the webinar and Q&A.
Read MoreDecember 7, 2017
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the fourth article in the blog series, and covers the configuration of the release workflows.
Read MoreDecember 5, 2017
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the third article in the blog series, and covers the configuration of the test case workflows.
Read MoreNovember 29, 2017
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customers in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the second article in the blog series, and covers the configuration of the requirements workflows.
Read MoreNovember 20, 2017
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments.
Read MoreApril 29, 2016
In this morning's Washington Post, there was an article about 'The new sheriff in town' describing how the new biotechnology and drug screening startups in Silicon Valley are colliding with the conservative, formal testing philosophy of the United States Food & Drug Administration (FDA).
September 18, 2015
When developing software, systems and hardware for use in medical devices, healthcare IT systems or pharmaceutical processes, you need to follow a requirements and quality management process that complies with the FDA Title 21 CFR Part 11 set of Federal Regulations. Part 11 (as it's more commonly called) defines the criteria under which electronic records and electronic
signatures are considered trustworthy, reliable, and equivalent to paper
records.