Posts Tagged 'Medical'

Medical AI: Software Diagnosing Health Issues?

May 6, 2024

The AI boom has prompted conversations across the internet and news about bots replacing humans in a variety of fields (most commonly writing and coding). But what about the healthcare and medical industries? These are typically thought of as requiring a human’s touch, intuition, and nuance — but that hasn’t stopped some from suggesting that AI robot doctors will be replacing all humans in the coming years.
As a company, we’ve seen almost two decades of software trends and shifts, as well as how these changes impact different industries. We also work closely with dozens of partners in the biotech and medical fields that rely on cutting-edge software every day. With that in mind, let’s discuss AI’s impact on healthcare today and where we anticipate it going. 

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Using the SpiraPlan Document Workflow Enhancements for GxP CFR Part 11 Projects

January 28, 2021

We're very excited about the upcoming release of SpiraPlan 6.7.1 for both our cloud and on-premise customers. In addition to the powerful new tools for developers and DevOps engineers, we also have some new document management enhancements that will be amazing for customers working in the life sciences, especially on GxP projects that have to follow FDA / EMA rules such as 21 CFR Part 11.

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Webinar Recap: How To Accelerate Software Testing, Validation & Compliance Of Your Medical Trials

March 30, 2020

On March 25 2020, Inflectra's Adam Sandman headlined a live webinar called: How To Accelerate Software Testing, Validation & Compliance Of Your Medical Trials. The webinar focuses on compliance with HIPAA and FDA 21 CFR Part 11 and discusses how SpiraPlan makes that compliance front and center of your software development and testing initiatives. 

If you missed the webinar, please enjoy this recap, complete with a video recording.

Webinar Agenda:

The webinar covered the following areas: 

  • The urgency around Software Validation & Testing
  • Best practices in Software Validation & Testing
  • SpiraPlan Compliance Features: Electronic Signatures, End-to-End Traceability, Audit Trails.
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Recording of Software Testing, Validation & Compliance in Healthcare Webinar

May 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.

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Recording of Testing & Compliance Challenges Webinar for Healthcare in the Cloud

March 12, 2018

In this presentation we discuss some of the unique testing and compliance requirements for IT projects in healthcare and the life sciences. We discuss the move to the cloud, the opportunities and challenges it will bring, and how the Inflectra platform can help. We then have a practical demonstration of our two products - SpiraTeam and Rapise - that can help you achieve compliance faster and more affordably than ever before.

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Configuring SpiraTeam for Testing in Validated Environments (Part 4)

December 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.

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Configuring SpiraTeam for Testing in Validated Environments (Part 3)

December 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.

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Configuring SpiraTeam for Testing in Validated Environments (Part 2)

November 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.

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Configuring SpiraTeam for Testing in Validated Environments (Part 1)

November 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.

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When the FDA Sheriff Comes to Town - You Need to be Ready!

April 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).

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