Inflectra | Part 1

Posts Tagged 'Part 1'

The Perils of Agile Estimation (Part 1)

March 23, 2021

Estimation has always been an inflection point in the software engineering world. Many developers admit that one of the hardest parts of their job is not about naming things or invalidating caches (as the old saying goes) but giving estimates. Certainly, for many experienced software engineers, estimates have always been the most frequent area of friction between software developers and managers. Both sides seem to have valid arguments: managers want to know how long things will take, as they need to manage budgets and customer expectations. Developers, on the other hand, know that most software tasks cannot be estimated accurately enough to satisfy the manager's needs. This friction has been so intense that it's given rise to the #NoEstimates movement and many flame wars on social media. But is the choice truly between one of these two extreme positions, or can a happy medium be found that satisfies both sides?

This series of articles attempts to explore and answer this question.

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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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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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Spira 5.0 Preview - Digital Signatures

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.

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