Inflectra | Healthcare

Posts Tagged 'Healthcare'

Recording of Software Testing, Validation & Compliance in Healthcare

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More